Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial
| Registry | NCT02838017, acronym TASC |
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| Status | Terminated - Based on results of an interim analysis, the study was halted for futility |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, prevention |
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| Enrollment | 504 (Actual) |
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| Sponsor | Endeavor Health (Other); collaborators: University of Chicago |
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| Conditions | Wound Complication, Complications; Cesarean Section |
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| Interventions | Tissue Adhesive, Sterile strips (Device) |
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| Dates | start 2016-11-01, primary completion 2018-06-01, completion 2018-06-01, first posted 2016-07-20, last updated 2019-08-14 |
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| Locations | 3 sites in United States |
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-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. 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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Tissue Adhesive | Experimental | Device: Tissue Adhesive | Tissue Adhesive will be placed over subcuticular suture closure. |
| Steri-Strips | Active comparator | Device: Sterile strips | Sterile strips will be placed over subcuticular suture closure. |
- Tissue Adhesive (Device), also known as Dermabond, Dermaflex, 2-octyl cyanoacrylate
- Sterile strips (Device), also known as Steri-Strips
+Outcome measures
Primary outcomes
- Number of Participants With Wound Complication [6-8 weeks from cesarean delivery]: Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation
Secondary outcomes
- Number of Participants With Readmission for Wound Complication [Within 8 weeks from cesarean delivery]
- Satisfaction With Cesarean Scar [6-8 weeks from cesarean delivery]: 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.
- Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication [Within 8 weeks of delivery]: The investigators will review medical records to assess for ambulatory visits for wound complaints
- Operative Time [At time of delivery]: The investigators will review operative records to assess operative time
- Number of Participants Requiring Antibiotic Treatment for Wound Complication [Within 8 weeks of delivery]: The investigators will review medical records to assess for antibiotic prescriptions for wound complications
+Eligibility
Sex: Female, accepts healthy volunteers
Inclusion Criteria:
* Women undergoing Pfannenstiel Cesarean delivery
Exclusion Criteria:
* 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
+Posted results
Participant flow
| Milestone | Tissue Adhesive | Sterile Strips |
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| Started | 252 | 252 |
| Completed | 238 | 241 |
| Not completed | 14 | 11 |
Outcome results
- Number of Participants With Wound Complication (Primary), Count of participants, Participants: Tissue Adhesive 18; Sterile Strips 19
- Number of Participants With Readmission for Wound Complication (Secondary), Count of participants, Participants: Tissue Adhesive 1; Sterile Strips 1
- Satisfaction With Cesarean Scar (Secondary), Median, score on a scale: Tissue Adhesive 1 (1.0 to 3.0); Sterile Strips 2 (1.0 to 4.0)
- Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication (Secondary), Count of participants, Participants: Tissue Adhesive 16; Sterile Strips 18
- Operative Time (Secondary), Median, min: Tissue Adhesive 58.5 (48.0 to 70.3); Sterile Strips 60 (51 to 72)
- Number of Participants Requiring Antibiotic Treatment for Wound Complication (Secondary), Count of participants, Participants: Tissue Adhesive 7; Sterile Strips 12
Adverse events
Time frame: 8 weeks
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Tissue Adhesive | 0/252 (0.0%) | 0/252 (0.0%) | 0/252 (0.0%) |
| Sterile Strips | 0/252 (0.0%) | 0/252 (0.0%) | 0/252 (0.0%) |
+Locations (3)
| Facility | City | Country | Status |
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| University of Chicago | Chicago, Illinois | United States | |
| NorthShore Evanston Hospital | Evanston, Illinois | United States | |
| NorthShore Highland Park Hospital | Highland Park, Illinois | United States | |
+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. PMID 18034920
- Mackeen 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. PMID 25479008
- Noorani 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. PMID 20878942
- Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-232. doi: 10.1097/AOG.0000000000000384. PMID 25004353
- Tipton 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. PMID 22108085
- Buresch 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. PMID 28796687
- Daykan 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. PMID 28153666
- Results publication: Braginsky 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. PMID 31306319
+Study documents
+Investigators