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Tissue Adhesive vs. Sterile Strips After Cesarean Delivery (TASC)

N

NorthShore University HealthSystem

Status

Terminated

Conditions

Wound Complication
Complications; Cesarean Section

Treatments

Device: Sterile strips
Device: Tissue Adhesive

Study type

Interventional

Funder types

Other

Identifiers

NCT02838017
EH16-095

Details and patient eligibility

About

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.

Enrollment

504 patients

Sex

Female

Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

504 participants in 2 patient groups

Tissue Adhesive
Experimental group
Description:
Tissue Adhesive will be placed over subcuticular suture closure.
Treatment:
Device: Tissue Adhesive
Steri-Strips
Active Comparator group
Description:
Sterile strips will be placed over subcuticular suture closure.
Treatment:
Device: Sterile strips

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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