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

The University of Texas Medical Branch, Galveston117 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

117

Conditions

Operative Time Wound Heal

Interventions

INSORB: subcuticular stapling deviceDEVICE

Under the skin stapling device that delivers absorbable staples

Subcuticular monocryl suture manufactured by EthiconDEVICE

Under the skin suture placed by hand

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

John Sealy Hospital at University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

Operating Time

Total time for the procedure

Time frame: Start of surgery through end of skin closure in minutes

Secondary Outcomes

Wound Cosmesis

A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.

Time frame: Time of surgery through six weeks post partum

Number of Participants With Composite Wound Complication

Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers

Time frame: Time of surgery through six weeks post partum

Post Operative Pain

Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain.

Time frame: 5-10 days

Number of Adverse Events

Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis

Time frame: Time of surgery through six weeks post partum

Use of Resources

Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures

Time frame: Time of surgery through six weeks post partum

Data from ClinicalTrials.gov

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