Postoperative PainNCT03195322
Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction
A study testing Pre-pectoral Tissue Expander in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Johns Hopkins University at 1 site in United States.
Trial summary
Primary Objective: To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life
- What is being tested?
- Pre-pectoral Tissue Expander
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be women, aged 18-75 years.
- Choose bilateral mastectomy (therapeutic or prophylactic) followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
- Have no inflammatory breast cancers.
- Be aware of the nature of her malignancy.
- Understand the study purpose, requirements, and risks.
- Be able and willing to give informed consent.
Who cannot join
- Plan to undergo final reconstruction with autologous material.
- Allergies to gentamicin, cefoxitin, lincomycin, vancomycin, or polymixin (antibiotics used in the pre-treatment of AlloDerm®).
- Active connective tissue disease.
- Current smokers.
- History of, or plan to undergo irradiation of the breasts.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University
Baltimore, Maryland, 21287
About this study
Official title: The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot
Primary Objective:
- To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage.
Read more
Secondary Objectives:
- To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement
- To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
- To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement.
- To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
- To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
- To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant.
- To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
- To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
- To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant.
- To describe the patient's final assessment of pre-pectoral reconstruction from free-form text.
Tertiary Objectives:
- To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.
Read the detailed description
Study participants meeting inclusion criteria will be enrolled prior to surgery. Once the patient has been seen by one of the Institutional Review Board (IRB)-approved study physicians at the initial clinic visit and informed consent has been obtained, pre-study patient-reported outcome (PRO) questionnaires will be distributed and collected by one of the IRB-approved healthcare providers (i.e. medical assistant, nurse, nurse-practitioner, or plastic surgeon). These questionnaires include the Pain Visual Analog Scale, the Patient Pain Assessment Questionnaire which assesses static and dynamic pain as well as nausea and interference with sleep, the Subjective Pain Survey, the preoperative Breast-Q: Reconstruction Module, the SF-36, and the Brief Pain Inventory-Short Form. Participants will then be asked to complete a general patient history form.
Patients will undergo bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage. Patients who are determined to be poor surgical candidates intra-operatively will be excluded from the study and receive standard of care reconstruction. All patient-specific surgical details will be recorded intra-operatively. See Figure 1 for a schematic of the first stage of reconstruction: bilateral mastectomy and tissue expander placement.
Following the surgery, postoperative pain will be assessed by the Pain Visual Analog Scale (VAS), the Patient Pain Assessment Questionnaire, and the Brief Pain Inventory-Short Form (BPI-SF); pain medication/opioid use and nausea/vomiting will be assessed by the Postoperative nausea and vomiting (PONV) Intensity Scale; and adverse events (AEs)/serious adverse events (SAEs) and the occurrence of complications (seroma, hematoma, cellulitis, and infection requiring expander removal) will be assessed by staff during the hospital stay (Day 1, Day 2, Day 3) and on Day 7 (±2 days) when participants return to clinic for the first follow-up visit after mastectomy and tissue expander placement. At this visit on Day 7, an updated medical history will be completed, pain medication and opioid use will be recorded, and participant complications/AEs/SAEs assessed. In order to minimize missing data, participants will be educated by an IRB-approved member to complete all possible questionnaire items. Furthermore, in order to avoid expectancy-bias, study team members will ensure that patients complete the PRO questionnaires before meeting with study healthcare providers for all postoperative follow-up appointments. Following the completion of all assessments on Day 7, patients will undergo initiation of tissue expander expansion carefully recording the rate and volume of fill.
Longer-term quality-of-life/health outcomes assessments will be performed on postoperative Day 30 (±4 days) and Day 60 (±7 days) after the initiation of tissue expander expansion. During these visits, pain scores (Pain Visual Analog Scale, Patient Pain Assessment Questionnaire, and Brief Pain Inventory-Short Form), pain medication/opioid use, postoperative Breast-Q, and SF-36 questionnaires will be administered. Day 60 follow-up is included as a tertiary endpoint to capture differences in residual pain. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up.
Following final reconstruction with tissue expander exchange for permanent implant, typically three months after mastectomy and tissue expander placement, all PRO questionnaires, postoperative static and dynamic pain, nausea/vomiting/opioid use, short-term changes in Quality of Life, complication rates, average hospital length of stay and residual pain will be assessed. Additionally, on Day 30, and Day 60 after permanent implant placement patients will be photographed comparing the breasts at rest and with pectoralis muscle flexion to assess for breast animation deformity using the Spear 4-point grading system. They will then be imaged using "VECTRA® XT 3D" digital imaging technology ("CANFIELD Scientific", Inc.) on Day 60. Differences in breast volume, surface area, shape, size, contour, and symmetry will be evaluated using the "VECTRA® XT" Analysis Module software. Day 60 follow-up is included as a tertiary endpoint to capture differences in cosmetic result and residual pain after final reconstruction. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up. See Figure 2 for a schematic of the second stage of reconstruction: tissue expander exchange for permanent implant.
*Patients will be called the morning of their Day 7, Day 30, and Day 60 appointments as a reminder. In the event they are unable to attend, every attempt will be made to reschedule within 2, 4, and 7 days, respectively.
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life, Breast Cancer, Breast Prosthesis; Pain
- Being tested
- Pre-pectoral Tissue Expander
- Keywords
- Immediate Breast Reconstruction, Pain Control, Post Mastectomy Pain Control, Acellular Dermal Matrix
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Breast Neoplasms, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-pectoral Tissue ExpanderProcedure or surgery
All participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
| Study group | Role | What they receive |
|---|---|---|
| Pre-pectoral Tissue Expander | Experimental | Pre-pectoral immediate tissue expander breast reconstruction with complete AlloDerm® coverage to reinforce breast tissues. Receives: Procedure: Pre-pectoral Tissue Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using Visual Analog Scale (VAS)
Postoperative static pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement) at Day 1
Measured: Day 1
Secondary outcomes (24)
Evaluation of Postoperative Dynamic Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS
Postoperative dynamic pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement) Day 1, Day 2, Day 3, and Day 7, before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS
Postoperative static pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement at Day 2, Day 3, and Day 7, before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.
Measured: Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using "BPI-SF" questionnaire
postoperative static pain scores with standard deviations from BPI-SF, will be measured on post-operative (after mastectomy and tissue expander placement) Day 1, Day 2, Day 3, and Day 7 before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Level of Postoperative opioid use after Mastectomy and Tissue Expander
Evaluation of level of opioids (type of opioids and dosage) which the patient required to alleviate the pain related to the insertion and expansion of tissue expander. Relevant information will be assessed by the patients' charts (when inpatient) and by patients' reports to study members (as an outpatient) on Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Number of participants with postoperative vomiting after Mastectomy and Tissue Expander placement using the PONV Intensity Scale
Evaluation of number of participants who report postoperative vomiting according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Number of participants with postoperative nausea after Mastectomy and Tissue Expander placement using the PONV Intensity Scale
Evaluation of number of participants who report postoperative nausea to either according the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire
Postoperative short-term changes in Quality of Life scores by using the Breast-Q questionnaire scores, on Day 30 after mastectomy and tissue expander placement.
Measured: Day 30
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire
Preoperative and postoperative (Day 30 after mastectomy and tissue expander placement) Quality of Life scores will be assessed by using the Breast-Q questionnaire scores. Changes in Quality of Life Scores will be assessed by subtracting preoperative score from the one recorded postoperative.
Measured: Baseline and Day 30
Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire
Postoperative short-term changes in Quality of Life scores by using the SF-36 Health Survey, after mastectomy and tissue expander placement on post-operative Day 7, and Day 30.
Measured: Day 7, Day 30
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire
Preoperative and postoperative (Day 7, 30 after mastectomy and tissue expander placement) Quality of Life scores will be assessed by using the SF-36 Health Survey. Changes in Quality of Life Scores will be assessed by subtracting preoperative score from the ones recorded postoperative.
Measured: Day 7, Day 30
Number of participants with any postoperative complication following mastectomy and tissue expander placement based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Postoperative complication rates will be assessed by patients' charts at Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after mastectomy and tissue expander placement. Number and characteristics of complications will be recorded.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Level of Postoperative opioid use after final breast reconstruction
Evaluation of level of opioids (type of opioids and dosage) which the patient required to alleviate the pain related to final breast reconstruction with permanent implant. Relevant information will be assessed by the patients' charts (when inpatient) and by patients' reports to study members (as an outpatient) on Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final reconstruction with permanent implant.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative vomiting after final breast reconstruction using the PONV Intensity Scale
Evaluation of number of participants who report postoperative vomiting according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final breast reconstruction with permanent implant.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative nausea after final breast reconstruction using the PONV Intensity Scale
Evaluation of number of participants who report postoperative nausea according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final breast reconstruction with permanent implant
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction with permanent implant by using Breast-Q questionnaire
Postoperative short-term changes in Quality of Life scores by using the Breast-Q questionnaire scores, on Day 30, and Day 60 after final breast reconstruction with permanent implant.
Measured: Day 30, 60
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using Breast-Q questionnaire
Preoperative, postoperative after mastectomy and tissue expander placement and postoperative after final breast reconstruction Quality of Life scores will be assessed by using the Breast-Q questionnaire scores. Changes in Quality of Life Scores will be assessed by subtracting the most recent score from the previous one, and the most recent from the very first one.
Measured: Day 30, 60
Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire
Postoperative short-term changes in Quality of Life scores by using the SF-36 Health Survey, after final breast reconstruction at post-operative Day 7, Day 30, and Day 60.
Measured: Day 7, Day 30, Day 60
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire
Preoperative, postoperative after mastectomy and tissue expander placement and postoperative after final breast reconstruction Quality of Life scores will be assessed by using the SF-36 Health Survey. Changes in Quality of Life Scores will be assessed by subtracting the most recent score from the previous one, and the most recent from the very first one.
Measured: Day 7-60
Number of participants with any postoperative complication following final breast reconstruction based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Postoperative complication rates will be assessed by patients' charts at Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final breast reconstruction with permanent implant. Number and characteristics of complications will be recorded.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative breast animation deformity assessed by Spear grading system and "VECTRA XT 3D"
Postoperative rates of breast animation deformity will be assessed at Day 7, Day 30, and Day 60 after final reconstruction with permanent implant, using the Spear 4-point grading system. Participants will then be imaged using VECTRA® XT 3D digital imaging technology ("CANFIELD Scientific, Inc.") on Day 60. Differences in breast volume, surface area, shape, size, contour, and symmetry will be evaluated using the "VECTRA® XT" Analysis Module software
Measured: Day 7, Day 30, Day 60
Evaluation of Hospital Length of Stay after final reconstruction in days
Hospital Length of Stay in days after final reconstruction with permanent implant will be assessed and recorder by reviewing patients' chart
Measured: Day 1-3
Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)
Postoperative static pain scores with standard deviations from VAS will be measured on post-operative at Day 1, Day 2, Day 3, and Day 7, Day 30, and Day 60 following final breast reconstruction.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Dynamic Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)
Postoperative dynamic pain scores with standard deviations from VAS will be measured on post-operative at Day 1, Day 2, Day3, and Day 7, Day 30, and Day 60 following final breast reconstruction.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using BPI-SF
Postoperative static pain scores from BPI-SF will be measured on post-operative at Day 1, Day 2, Day3, and Day 7, Day 30, and Day 60 following final breast reconstruction.
Measured: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Oct 2017
- Primary completion30 Nov 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gedge D Rosson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195322
- Sponsor's protocol ID
- IRB00091477
- Status last verified
- Dec 2021
- First submitted
- 18 Apr 2017
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment, there is no plan to share Individual Participant Data (IPD)
Publications
American Cancer Society. Breast Cancer Facts and Figures 2015-2016. http://www.cancer.org. Accessed November 5, 2015.
Lucas DJ, Sabino J, Shriver CD, Pawlik TM, Singh DP, Vertrees AE. Doing more: trends in breast cancer surgery, 2005 to 2011. Am Surg. 2015 Jan;81(1):74-80.
PubMed 25569069Albornoz CR, Bach PB, Mehrara BJ, Disa JJ, Pusic AL, McCarthy CM, Cordeiro PG, Matros E. A paradigm shift in U.S. Breast reconstruction: increasing implant rates. Plast Reconstr Surg. 2013 Jan;131(1):15-23. doi: 10.1097/PRS.0b013e3182729cde.
PubMed 23271515Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007.
PubMed 11373553Girotto JA, Schreiber J, Nahabedian MY. Breast reconstruction in the elderly: preserving excellent quality of life. Ann Plast Surg. 2003 Jun;50(6):572-8. doi: 10.1097/01.SAP.0000069064.68579.19.
PubMed 12783001Harless C, Jacobson SR. Current strategies with 2-staged prosthetic breast reconstruction. Gland Surg. 2015 Jun;4(3):204-11. doi: 10.3978/j.issn.2227-684X.2015.04.22.
PubMed 26161305Susarla SM, Ganske I, Helliwell L, Morris D, Eriksson E, Chun YS. Comparison of clinical outcomes and patient satisfaction in immediate single-stage versus two-stage implant-based breast reconstruction. Plast Reconstr Surg. 2015 Jan;135(1):1e-8e. doi: 10.1097/PRS.0000000000000803.
PubMed 25539329Sbitany H, Sandeen SN, Amalfi AN, Davenport MS, Langstein HN. Acellular dermis-assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009 Dec;124(6):1735-1740. doi: 10.1097/PRS.0b013e3181bf803d.
PubMed 19952627Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
PubMed 8880841Spear SL, Schwartz J, Dayan JH, Clemens MW. Outcome assessment of breast distortion following submuscular breast augmentation. Aesthetic Plast Surg. 2009 Jan;33(1):44-8. doi: 10.1007/s00266-008-9275-y. Epub 2008 Dec 4.
PubMed 19052809Vardanian AJ, Clayton JL, Roostaeian J, Shirvanian V, Da Lio A, Lipa JE, Crisera C, Festekjian JH. Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix. Plast Reconstr Surg. 2011 Nov;128(5):403e-410e. doi: 10.1097/PRS.0b013e31822b6637.
PubMed 22030500Reitsamer R, Peintinger F. Prepectoral implant placement and complete coverage with porcine acellular dermal matrix: a new technique for direct-to-implant breast reconstruction after nipple-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Feb;68(2):162-7. doi: 10.1016/j.bjps.2014.10.012. Epub 2014 Oct 16.
PubMed 25455288Lee KT, Mun GH. Updated Evidence of Acellular Dermal Matrix Use for Implant-Based Breast Reconstruction: A Meta-analysis. Ann Surg Oncol. 2016 Feb;23(2):600-10. doi: 10.1245/s10434-015-4873-9. Epub 2015 Oct 5.
PubMed 26438439Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
PubMed 1026900Kim MS, Sbalchiero JC, Reece GP, Miller MJ, Beahm EK, Markey MK. Assessment of breast aesthetics. Plast Reconstr Surg. 2008 Apr;121(4):186e-194e. doi: 10.1097/01.prs.0000304593.74672.b8.
PubMed 18349598
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot
- ClinicalTrials.gov ID
- NCT03195322
- Acronym / sponsor ID
- IRB00091477
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life, Breast Cancer, Breast Prosthesis; Pain
- Keywords
- Immediate Breast Reconstruction, Pain Control, Post Mastectomy Pain Control, Acellular Dermal Matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage.
Secondary Objectives:
- To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement
- To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
- To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement.
- To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
- To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
- To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant.
- To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
- To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
- To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant.
- To describe the patient's final assessment of pre-pectoral reconstruction from free-form text.
Tertiary Objectives:
- To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.
Detailed description
Study participants meeting inclusion criteria will be enrolled prior to surgery. Once the patient has been seen by one of the Institutional Review Board (IRB)-approved study physicians at the initial clinic visit and informed consent has been obtained, pre-study patient-reported outcome (PRO) questionnaires will be distributed and collected by one of the IRB-approved healthcare providers (i.e. medical assistant, nurse, nurse-practitioner, or plastic surgeon). These questionnaires include the Pain Visual Analog Scale, the Patient Pain Assessment Questionnaire which assesses static and dynamic pain as well as nausea and interference with sleep, the Subjective Pain Survey, the preoperative Breast-Q: Reconstruction Module, the SF-36, and the Brief Pain Inventory-Short Form. Participants will then be asked to complete a general patient history form.
Patients will undergo bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage. Patients who are determined to be poor surgical candidates intra-operatively will be excluded from the study and receive standard of care reconstruction. All patient-specific surgical details will be recorded intra-operatively. See Figure 1 for a schematic of the first stage of reconstruction: bilateral mastectomy and tissue expander placement.
Following the surgery, postoperative pain will be assessed by the Pain Visual Analog Scale (VAS), the Patient Pain Assessment Questionnaire, and the Brief Pain Inventory-Short Form (BPI-SF); pain medication/opioid use and nausea/vomiting will be assessed by the Postoperative nausea and vomiting (PONV) Intensity Scale; and adverse events (AEs)/serious adverse events (SAEs) and the occurrence of complications (seroma, hematoma, cellulitis, and infection requiring expander removal) will be assessed by staff during the hospital stay (Day 1, Day 2, Day 3) and on Day 7 (±2 days) when participants return to clinic for the first follow-up visit after mastectomy and tissue expander placement. At this visit on Day 7, an updated medical history will be completed, pain medication and opioid use will be recorded, and participant complications/AEs/SAEs assessed. In order to minimize missing data, participants will be educated by an IRB-approved member to complete all possible questionnaire items. Furthermore, in order to avoid expectancy-bias, study team members will ensure that patients complete the PRO questionnaires before meeting with study healthcare providers for all postoperative follow-up appointments. Following the completion of all assessments on Day 7, patients will undergo initiation of tissue expander expansion carefully recording the rate and volume of fill.
Longer-term quality-of-life/health outcomes assessments will be performed on postoperative Day 30 (±4 days) and Day 60 (±7 days) after the initiation of tissue expander expansion. During these visits, pain scores (Pain Visual Analog Scale, Patient Pain Assessment Questionnaire, and Brief Pain Inventory-Short Form), pain medication/opioid use, postoperative Breast-Q, and SF-36 questionnaires will be administered. Day 60 follow-up is included as a tertiary endpoint to capture differences in residual pain. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up.
Following final reconstruction with tissue expander exchange for permanent implant, typically three months after mastectomy and tissue expander placement, all PRO questionnaires, postoperative static and dynamic pain, nausea/vomiting/opioid use, short-term changes in Quality of Life, complication rates, average hospital length of stay and residual pain will be assessed. Additionally, on Day 30, and Day 60 after permanent implant placement patients will be photographed comparing the breasts at rest and with pectoralis muscle flexion to assess for breast animation deformity using the Spear 4-point grading system. They will then be imaged using "VECTRA® XT 3D" digital imaging technology ("CANFIELD Scientific", Inc.) on Day 60. Differences in breast volume, surface area, shape, size, contour, and symmetry will be evaluated using the "VECTRA® XT" Analysis Module software. Day 60 follow-up is included as a tertiary endpoint to capture differences in cosmetic result and residual pain after final reconstruction. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up. See Figure 2 for a schematic of the second stage of reconstruction: tissue expander exchange for permanent implant.
*Patients will be called the morning of their Day 7, Day 30, and Day 60 appointments as a reminder. In the event they are unable to attend, every attempt will be made to reschedule within 2, 4, and 7 days, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-pectoral Tissue Expander | Experimental | Procedure: Pre-pectoral Tissue ExpanderPre-pectoral immediate tissue expander breast reconstruction with complete AlloDerm® coverage to reinforce breast tissues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be women, aged 18-75 years.
- Choose bilateral mastectomy (therapeutic or prophylactic) followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
- Have no inflammatory breast cancers.
- Be aware of the nature of her malignancy.
- Understand the study purpose, requirements, and risks.
Key exclusion criteria (5 listed)
- Plan to undergo final reconstruction with autologous material.
- Allergies to gentamicin, cefoxitin, lincomycin, vancomycin, or polymixin (antibiotics used in the pre-treatment of AlloDerm®).
- Active connective tissue disease.
- Current smokers.
- History of, or plan to undergo irradiation of the breasts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-pectoral Tissue ExpanderAll participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage. | Procedure or surgery | Pre-pectoral Tissue Expander |
Primary outcome
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using Visual Analog Scale (VAS)
Time frame: Day 1
Postoperative static pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement) at Day 1
24 secondary outcomes
Evaluation of Postoperative Dynamic Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS
Time frame: Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using "BPI-SF" questionnaire
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Level of Postoperative opioid use after Mastectomy and Tissue Expander
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Number of participants with postoperative vomiting after Mastectomy and Tissue Expander placement using the PONV Intensity Scale
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Number of participants with postoperative nausea after Mastectomy and Tissue Expander placement using the PONV Intensity Scale
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire
Time frame: Day 30
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire
Time frame: Baseline and Day 30
Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire
Time frame: Day 7, Day 30
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire
Time frame: Day 7, Day 30
Number of participants with any postoperative complication following mastectomy and tissue expander placement based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Level of Postoperative opioid use after final breast reconstruction
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative vomiting after final breast reconstruction using the PONV Intensity Scale
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative nausea after final breast reconstruction using the PONV Intensity Scale
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction with permanent implant by using Breast-Q questionnaire
Time frame: Day 30, 60
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using Breast-Q questionnaire
Time frame: Day 30, 60
Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire
Time frame: Day 7, Day 30, Day 60
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire
Time frame: Day 7-60
Number of participants with any postoperative complication following final breast reconstruction based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative breast animation deformity assessed by Spear grading system and "VECTRA XT 3D"
Time frame: Day 7, Day 30, Day 60
Evaluation of Hospital Length of Stay after final reconstruction in days
Time frame: Day 1-3
Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Dynamic Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using BPI-SF
Time frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- BackgroundAmerican Cancer Society. Breast Cancer Facts and Figures 2015-2016. http://www.cancer.org. Accessed November 5, 2015.
- Background: PubMed 25569069Lucas DJ, Sabino J, Shriver CD, Pawlik TM, Singh DP, Vertrees AE. Doing more: trends in breast cancer surgery, 2005 to 2011. Am Surg. 2015 Jan;81(1):74-80.
- Background: PubMed 23271515Albornoz CR, Bach PB, Mehrara BJ, Disa JJ, Pusic AL, McCarthy CM, Cordeiro PG, Matros E. A paradigm shift in U.S. Breast reconstruction: increasing implant rates. Plast Reconstr Surg. 2013 Jan;131(1):15-23. doi: 10.1097/PRS.0b013e3182729cde.
- Background: PubMed 11373553Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007.
- Background: PubMed 12783001Girotto JA, Schreiber J, Nahabedian MY. Breast reconstruction in the elderly: preserving excellent quality of life. Ann Plast Surg. 2003 Jun;50(6):572-8. doi: 10.1097/01.SAP.0000069064.68579.19.
- Background: PubMed 26161305Harless C, Jacobson SR. Current strategies with 2-staged prosthetic breast reconstruction. Gland Surg. 2015 Jun;4(3):204-11. doi: 10.3978/j.issn.2227-684X.2015.04.22.
- Background: PubMed 25539329Susarla SM, Ganske I, Helliwell L, Morris D, Eriksson E, Chun YS. Comparison of clinical outcomes and patient satisfaction in immediate single-stage versus two-stage implant-based breast reconstruction. Plast Reconstr Surg. 2015 Jan;135(1):1e-8e. doi: 10.1097/PRS.0000000000000803.
- Background: PubMed 19952627Sbitany H, Sandeen SN, Amalfi AN, Davenport MS, Langstein HN. Acellular dermis-assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009 Dec;124(6):1735-1740. doi: 10.1097/PRS.0b013e3181bf803d.
- Background: PubMed 8880841Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
- Background: PubMed 19052809Spear SL, Schwartz J, Dayan JH, Clemens MW. Outcome assessment of breast distortion following submuscular breast augmentation. Aesthetic Plast Surg. 2009 Jan;33(1):44-8. doi: 10.1007/s00266-008-9275-y. Epub 2008 Dec 4.
- Background: PubMed 22030500Vardanian AJ, Clayton JL, Roostaeian J, Shirvanian V, Da Lio A, Lipa JE, Crisera C, Festekjian JH. Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix. Plast Reconstr Surg. 2011 Nov;128(5):403e-410e. doi: 10.1097/PRS.0b013e31822b6637.
- Background: PubMed 25455288Reitsamer R, Peintinger F. Prepectoral implant placement and complete coverage with porcine acellular dermal matrix: a new technique for direct-to-implant breast reconstruction after nipple-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Feb;68(2):162-7. doi: 10.1016/j.bjps.2014.10.012. Epub 2014 Oct 16.
- Individual participant dataSharing planned: No. At the moment, there is no plan to share Individual Participant Data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gedge D Rosson, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-pectoral Tissue Expander in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using Visual Analog Scale (VAS) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195322, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.