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

The University of Texas System (UT)

Status: Terminated

Conditions: Wound Heal; Operative Time

Treatments: Device: INSORB: subcuticular stapling device; Device: Subcuticular monocryl suture manufactured by Ethicon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05112640

21-0045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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117 participants in 2 patient groups

Suture wound closure

Active Comparator group

Description:

Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.

Treatment:

Device: Subcuticular monocryl suture manufactured by Ethicon

Absorbable staple wound closure

Experimental group

Description:

Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.

Treatment:

Device: INSORB: subcuticular stapling device