Acellular Dermal Matrix in Breast ReconstructionNCT04710537
Comparing AlloDerm and DermACELL in Breast Reconstruction
A study testing AlloDerm and DermACELL in people with Acellular Dermal Matrix in Breast Reconstruction, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acellular Dermal Matrix in Breast Reconstruction
- What is being tested?
- AlloDerm and DermACELL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2021to 26 Jul 2022
- 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
- Female patients over the age of 18
- May be undergoing either therapeutic or prophylactic mastectomy
- Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders
Who cannot join
- Patients who wish to avoid the use of ADM in their reconstruction
- History of radiation of the breast
- Unilateral mastectomies
- Direct to implant breast reconstruction (not utilizing a tissue expander)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DAVinci Plastic Surgery
Washington D.C., District of Columbia, 20016
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality
This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.
Read the detailed description
The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstruction. Patients who are undergoing bilateral mastectomies with tissue expanders and acellular dermal matrix (ADM) with one of the investigators' two surgeons, Dr. Steven Davison or Dr. Ximena Pinell, are eligible to be enrolled. Patients' breasts will be randomized to receive either AlloDerm or DermACELL so that each patient had AlloDerm placed in one breast and DermACELL placed in the other on the day of surgery. Then, the following data for each breast will be recorded: time until drain removal, total drain output, time until first expander fill, and occurrences of infection and seroma.
- Being tested
- AlloDerm, DermACELL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloDermOther
Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.
DermACELLOther
Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.
| Study group | Role | What they receive |
|---|---|---|
| AlloDerm | Active comparator | AlloDerm will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. AlloDERM will be placed in the breast opposite to the breast in which DermACELL is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa. Receives: Other: AlloDerm |
| DermACELL | Active comparator | DermACELL will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. DermACELL will be placed in the breast opposite to the breast in which AlloDERM is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa. Receives: Other: DermACELL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain time
Number of days between surgical placement of drains and time until drains are removed.
Measured: Up to 90 days
Drain output
Total amount of fluid collected by the drains until their removal (measured in cc).
Measured: Up to 90 days
Incidence of Seroma
Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.
Measured: Up to 90 days
Incidence of Infection
Each patient will be evaluated for incidence of infection in either breast at postoperative visits.
Measured: Up to 90 days
Secondary outcomes (3)
Incidence of Skin necrosis
Each patient will be evaluated for skin necrosis of either breast at postoperative visits.
Measured: Up to 90 days
Incidence of Hematoma
Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits.
Measured: Up to 90 days
Incidence of Device Explantation
If patients require device explantation in one breast due to complications (e.g. infection).
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start21 Oct 2021
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acellular Dermal Matrix in Breast ReconstructionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- At the time of surgery, the assignment of AlloDerm vs. DermACELL to the patient's left and right breasts will be randomized. The surgical assistant, scrub tech, and circulators can randomly choose which acellular dermal matrix product will be used "first" or "second". The ADM product that will be used first will be placed in either the left or right breast, depending on what breast the surgeon decided to perform the surgery on first. Then, the second breast that is operated on will receive whichever ADM product was not used on the first breast.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven P Davison, MD, Principal investigator, Sibley Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710537
- Sponsor's protocol ID
- IRB00248878
- Status last verified
- Aug 2022
- First submitted
- 29 Dec 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zenn MR, Salzberg CA. A Direct Comparison of Alloderm-Ready to Use (RTU) and DermACELL in Immediate Breast Implant Reconstruction. Eplasty. 2016 Aug 11;16:e23. eCollection 2016.
PubMed 27602176Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study. Plast Reconstr Surg. 2017 Mar;139(3):521-528. doi: 10.1097/PRS.0000000000003048.
PubMed 28234811Steiner CA, Weiss AJ, Barrett ML, Fingar KR, Davis PH. Trends in Bilateral and Unilateral Mastectomies in Hospital Inpatient and Ambulatory Settings, 2005-2013. 2016 Feb [updated 2016 Mar]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #201. Available from http://www.ncbi.nlm.nih.gov/books/NBK367629/
PubMed 27253008
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality
- ClinicalTrials.gov ID
- NCT04710537
- Acronym / sponsor ID
- IRB00248878
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 14 Jan 2021 (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.
This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.
Detailed description
The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstruction. Patients who are undergoing bilateral mastectomies with tissue expanders and acellular dermal matrix (ADM) with one of the investigators' two surgeons, Dr. Steven Davison or Dr. Ximena Pinell, are eligible to be enrolled. Patients' breasts will be randomized to receive either AlloDerm or DermACELL so that each patient had AlloDerm placed in one breast and DermACELL placed in the other on the day of surgery. Then, the following data for each breast will be recorded: time until drain removal, total drain output, time until first expander fill, and occurrences of infection and seroma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- At the time of surgery, the assignment of AlloDerm vs. DermACELL to the patient's left and right breasts will be randomized. The surgical assistant, scrub tech, and circulators can randomly choose which acellular dermal matrix product will be used "first" or "second". The ADM product that will be used first will be placed in either the left or right breast, depending on what breast the surgeon decided to perform the surgery on first. Then, the second breast that is operated on will receive whichever ADM product was not used on the first breast.
| Arm | Type | Receives |
|---|---|---|
| AlloDerm | Active comparator | Other: AlloDermAlloDerm will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. AlloDERM will be placed in the breast opposite to the breast in which DermACELL is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa. |
| DermACELL | Active comparator | Other: DermACELLDermACELL will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. DermACELL will be placed in the breast opposite to the breast in which AlloDERM is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients over the age of 18
- May be undergoing either therapeutic or prophylactic mastectomy
- Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders
Key exclusion criteria (4 listed)
- Patients who wish to avoid the use of ADM in their reconstruction
- History of radiation of the breast
- Unilateral mastectomies
- Direct to implant breast reconstruction (not utilizing a tissue expander)
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 |
|---|---|---|
| AlloDermEnrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery. | Other | AlloDerm |
| DermACELLEnrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery. | Other | DermACELL |
Primary outcome
Drain time
Time frame: Up to 90 days
Number of days between surgical placement of drains and time until drains are removed.
Drain output
Time frame: Up to 90 days
Total amount of fluid collected by the drains until their removal (measured in cc).
Incidence of Seroma
Time frame: Up to 90 days
Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.
Incidence of Infection
Time frame: Up to 90 days
Each patient will be evaluated for incidence of infection in either breast at postoperative visits.
3 secondary outcomes
Incidence of Skin necrosis
Time frame: Up to 90 days
Incidence of Hematoma
Time frame: Up to 90 days
Incidence of Device Explantation
Time frame: Up to 90 days
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 4 Aug 2022.
- Background: PubMed 27602176Zenn MR, Salzberg CA. A Direct Comparison of Alloderm-Ready to Use (RTU) and DermACELL in Immediate Breast Implant Reconstruction. Eplasty. 2016 Aug 11;16:e23. eCollection 2016.
- Background: PubMed 28234811Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study. Plast Reconstr Surg. 2017 Mar;139(3):521-528. doi: 10.1097/PRS.0000000000003048.
- Background: PubMed 27253008Steiner CA, Weiss AJ, Barrett ML, Fingar KR, Davis PH. Trends in Bilateral and Unilateral Mastectomies in Hospital Inpatient and Ambulatory Settings, 2005-2013. 2016 Feb [updated 2016 Mar]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #201. Available from http://www.ncbi.nlm.nih.gov/books/NBK367629/
- Individual participant dataSharing planned: No
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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.
Steven P Davison, MD principal investigator
Sibley Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlloDerm and DermACELL in people with Acellular Dermal Matrix in Breast Reconstruction, run by Johns Hopkins University at 2 sites 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 3 inclusion and 4 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Drain time (time frame: Up to 90 days). The study lists 4 primary outcomes in all. 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 NCT04710537, which also lists 3 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 4 Aug 2022.