Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Subcuticular monocryl suture, Subcuticular absorbable staple using Insorb device.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial
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
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 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.
Interventions
- Procedure Subcuticular monocryl suture
Under the skin suture placed by hand - Device Subcuticular absorbable staple using Insorb device
Under the skin stapling device that delivers absorbable staples
Primary outcome measures
- Operating time [Time frame: Time from the start of surgery through end of skin closure up to 8 hours]
Secondary outcome measures (2)
- Wound Cosmesis [Time frame: Up to six weeks post partum]
- Post Operative Pain [Time frame: up to 3 days post-operatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Inova Fairfax Medical Campus — Falls Church
Identifiers
NCT: NCT07167199 · INOVA-2024-333