Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
Purpose
Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.
Conditions
- Operative Time
- Wound Heal
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 18-50 years of age - Women ≥ 24 weeks viable gestation - Will be undergoing cesarean delivery
Exclusion Criteria
- Patient unwilling or unable to provide consent. - No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery. - Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other - Decision not to have skin closure (e.g. secondary wound closure, mesh closure) - Current skin infection - Coagulopathy - High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery) - Incarcerated individuals - Intraamniotic infection - Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Reviewers of wound cosmetics during the post operative time will be blind to the intervention. However, surgeon at the time skin closure and patient will not be blinded to the intervention.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Suture wound closure |
Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. |
|
|
Experimental Absorbable staple wound closure |
Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Medical Branch, Galveston
Study Contact
Detailed Description
This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.