Clinical trial NCT02838017: Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
Official title: Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Complication
Complications; Cesarean Section
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2016-07-20
Enrollment: 504
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Wound Complication
timeFrame: 6-8 weeks from cesarean delivery
Secondary outcomes:
measure: Number of Participants With Readmission for Wound Complication
timeFrame: Within 8 weeks from cesarean delivery
measure: Satisfaction With Cesarean Scar
timeFrame: 6-8 weeks from cesarean delivery
measure: Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication
timeFrame: Within 8 weeks of delivery
measure: Operative Time
timeFrame: At time of delivery
measure: Number of Participants Requiring Antibiotic Treatment for Wound Complication
timeFrame: Within 8 weeks of delivery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore Evanston Hospital
state: Illinois
city: Highland Park
country: United States
facility: NorthShore Highland Park Hospital
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Beth Plunkett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endeavor Health
name: Lena Braginsky, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1185/030079908x253807.
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;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
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.
citation: 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.
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.
citation: 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.
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.
citation: 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.