Tissue Adhesive vs. Sterile Strips After Cesarean Delivery

Wound Complication Clinical Trial

— TASC  

Official title:

Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02838017
• Other study ID #: EH16-095
• Status: Terminated
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2019
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 504
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Wound Complication

Intervention

Device:
• Tissue Adhesive

• Sterile strips

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	NorthShore Evanston Hospital	Evanston	Illinois
United States	NorthShore Highland Park Hospital	Highland Park	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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;(12):CD009516. doi: 10.1002/14651858.CD009516.pub2. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-32. doi: 10.1097/AOG.0000000000000384. Erratum in: Obstet Gynecol. 2016 Sep;128(3):660. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Wound Complication	Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation	6-8 weeks from cesarean delivery
Secondary	Number of Participants With Readmission for Wound Complication		Within 8 weeks from cesarean delivery
Secondary	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.	6-8 weeks from cesarean delivery
Secondary	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	Within 8 weeks of delivery
Secondary	Operative Time	The investigators will review operative records to assess operative time	At time of delivery
Secondary	Number of Participants Requiring Antibiotic Treatment for Wound Complication	The investigators will review medical records to assess for antibiotic prescriptions for wound complications	Within 8 weeks of delivery

External Links

•   Patient Scar Scale