Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery


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.


  • Operative Time
  • Wound Heal


Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Accepts Healthy Volunteers

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

Study Type
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
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

ArmDescriptionAssigned Intervention
Active Comparator
Suture wound closure
Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.
  • Device: Subcuticular monocryl suture manufactured by Ethicon
    Under the skin suture placed by hand
Absorbable staple wound closure
Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.
  • Device: INSORB: subcuticular stapling device
    Under the skin stapling device that delivers absorbable staples

Recruiting Locations

John Sealy Hospital at University of Texas Medical Branch
Galveston, Texas 77555
Brett Goldman, MD

More Details

The University of Texas Medical Branch, Galveston

Study Contact

Brett Goldman, MD

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.