Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-09-01

Brief Summary

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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

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Detailed Description

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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 Inova. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Suture wound closure

Absorbable Moncryl sutures for closure of cesarean skin incision

Group Type ACTIVE_COMPARATOR

Subcuticular monocryl suture

Intervention Type PROCEDURE

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 CooperSurgical.

Group Type EXPERIMENTAL

Subcuticular absorbable staple using Insorb device

Intervention Type DEVICE

Under the skin stapling device that delivers absorbable staples

Interventions

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Subcuticular monocryl suture

Under the skin suture placed by hand

Intervention Type PROCEDURE

Subcuticular absorbable staple using Insorb device

Under the skin stapling device that delivers absorbable staples

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No