Wound ComplicationTASCNCT02838017
Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
A study testing Tissue Adhesive and Sterile strips in people with Wound Complication and Complications; Cesarean Section, run by Endeavor Health at 3 sites in United States.
Trial summary
The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\adhesive. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Complication, Complications; Cesarean Section
- What is being tested?
- Tissue Adhesive and Sterile strips
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women undergoing Pfannenstiel Cesarean delivery
Who cannot join
- Inability to provide informed consent in English
- Planned use of staples for skin closure
- Unavailability of research personnel to accomplish consent and randomization at the time of cesarean
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60637
NorthShore Evanston Hospital
Evanston, Illinois, 60201
NorthShore Highland Park Hospital
Highland Park, Illinois, 60035
About this study
Official title: Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial
The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.
- Being tested
- Tissue Adhesive, Sterile strips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue AdhesiveDevice
Also called Dermabond, Dermaflex, 2-octyl cyanoacrylate
Sterile stripsDevice
Also called Steri-Strips
| Study group | Role | What they receive |
|---|---|---|
| Tissue Adhesive | Experimental | Tissue Adhesive will be placed over subcuticular suture closure. Receives: Device: Tissue Adhesive |
| Steri-Strips | Active comparator | Sterile strips will be placed over subcuticular suture closure. Receives: Device: Sterile strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Wound Complication
Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation
Measured: 6-8 weeks from cesarean delivery
Secondary outcomes (5)
Number of Participants With Readmission for Wound Complication
Measured: Within 8 weeks from cesarean delivery
Satisfaction With Cesarean Scar
The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups.
Please see website in links section for more details on this assessment tool.
Measured: 6-8 weeks from cesarean delivery
Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication
The investigators will review medical records to assess for ambulatory visits for wound complaints
Measured: Within 8 weeks of delivery
Operative Time
The investigators will review operative records to assess operative time
Measured: At time of delivery
Number of Participants Requiring Antibiotic Treatment for Wound Complication
The investigators will review medical records to assess for antibiotic prescriptions for wound complications
Measured: Within 8 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Based on results of an interim analysis, the study was halted for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Principal investigator, Beth Plunkett, Endeavor Health
- Investigators
- Beth Plunkett, MD, Principal investigator, Endeavor HealthLena Braginsky, MD, Study director, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838017
- Sponsor's protocol ID
- EH16-095
- Acronym
- TASC
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2016
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, will be available upon request.
Publications
Souza EC, Fitaroni RB, Januzelli DM, Macruz HM, Camacho JC, Souza MR. Use of 2-octyl cyanoacrylate for skin closure of sternal incisions in cardiac surgery: observations of microbial barrier effects. Curr Med Res Opin. 2008 Jan;24(1):151-5. doi: 10.1185/030079908x253807.
PubMed 18034920Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
PubMed 25479008Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214.
PubMed 20878942Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-232. doi: 10.1097/AOG.0000000000000384.
PubMed 25004353Tipton AM, Cohen SA, Chelmow D. Wound infection in the obese pregnant woman. Semin Perinatol. 2011 Dec;35(6):345-9. doi: 10.1053/j.semperi.2011.05.020.
PubMed 22108085Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.
PubMed 28796687Daykan Y, Sharon-Weiner M, Pasternak Y, Tzadikevitch-Geffen K, Markovitch O, Sukenik-Halevy R, Biron-Shental T. Skin closure at cesarean delivery, glue vs subcuticular sutures: a randomized controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):406.e1-406.e5. doi: 10.1016/j.ajog.2017.01.009. Epub 2017 Jan 30.
PubMed 28153666Braginsky L, Javellana M, Cleveland E, Elue R, Wang C, Boyle D, Plunkett BA. Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):295-301. doi: 10.1097/AOG.0000000000003367.
PubMed 31306319
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02838017
- Acronym / sponsor ID
- TASC / EH16-095
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on results of an interim analysis, the study was halted for futility
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- Nov 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue Adhesive | Experimental | Device: Tissue AdhesiveTissue Adhesive will be placed over subcuticular suture closure. |
| Steri-Strips | Active comparator | Device: Sterile stripsSterile strips will be placed over subcuticular suture closure. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing Pfannenstiel Cesarean delivery
Key exclusion criteria (3 listed)
- Inability to provide informed consent in English
- Planned use of staples for skin closure
- Unavailability of research personnel to accomplish consent and randomization at the time of cesarean
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 |
|---|---|---|
| Tissue AdhesiveAlso: Dermabond, Dermaflex, 2-octyl cyanoacrylate | Device | Tissue Adhesive |
| Sterile stripsAlso: Steri-Strips | Device | Steri-Strips |
Primary outcome
Number of Participants With Wound Complication
Time frame: 6-8 weeks from cesarean delivery
Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation
5 secondary outcomes
Number of Participants With Readmission for Wound Complication
Time frame: Within 8 weeks from cesarean delivery
Satisfaction With Cesarean Scar
Time frame: 6-8 weeks from cesarean delivery
Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication
Time frame: Within 8 weeks of delivery
Operative Time
Time frame: At time of delivery
Number of Participants Requiring Antibiotic Treatment for Wound Complication
Time frame: Within 8 weeks of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18034920Souza EC, Fitaroni RB, Januzelli DM, Macruz HM, Camacho JC, Souza MR. Use of 2-octyl cyanoacrylate for skin closure of sternal incisions in cardiac surgery: observations of microbial barrier effects. Curr Med Res Opin. 2008 Jan;24(1):151-5. doi: 10.1185/030079908x253807.
- Background: PubMed 25479008Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
- Background: PubMed 20878942Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214.
- Background: PubMed 25004353Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-232. doi: 10.1097/AOG.0000000000000384.
- Background: PubMed 22108085Tipton AM, Cohen SA, Chelmow D. Wound infection in the obese pregnant woman. Semin Perinatol. 2011 Dec;35(6):345-9. doi: 10.1053/j.semperi.2011.05.020.
- Background: PubMed 28796687Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.
- Background: PubMed 28153666Daykan Y, Sharon-Weiner M, Pasternak Y, Tzadikevitch-Geffen K, Markovitch O, Sukenik-Halevy R, Biron-Shental T. Skin closure at cesarean delivery, glue vs subcuticular sutures: a randomized controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):406.e1-406.e5. doi: 10.1016/j.ajog.2017.01.009. Epub 2017 Jan 30.
- Derived from this study: PubMed 31306319Braginsky L, Javellana M, Cleveland E, Elue R, Wang C, Boyle D, Plunkett BA. Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):295-301. doi: 10.1097/AOG.0000000000003367.
- Patient Scar ScaleLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, will be available upon request.
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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.
Beth Plunkett, MD principal investigator
Endeavor Health
Lena Braginsky, MD study director
Endeavor Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Adhesive and Sterile strips in people with Wound Complication and Complications; Cesarean Section, run by Endeavor Health at 3 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Wound Complication (time frame: 6-8 weeks from cesarean delivery). 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 NCT02838017, which also lists 8 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 14 Aug 2019.