Tissue Adhesive vs. Sterile Strips in Cesarean Delivery
Status: | Terminated |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 2/7/2019 |
Start Date: | November 2016 |
End Date: | June 2018 |
A Randomized Controlled Trial of Tissue Adhesive Compared to Sterile Strips for Cesarean Delivery (TASC)
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.
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.
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
We found this trial at
3
sites
University of Chicago One of the world's premier academic and research institutions, the University of...
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