About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-50 years of age
Women ≥ 24 weeks viable gestation
Will be undergoing cesarean delivery
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Subcuticular monocryl suture
Procedure/SurgeryUnder the skin suture placed by hand
Subcuticular absorbable staple using Insorb device
DeviceUnder the skin stapling device that delivers absorbable staples
Treatment groups
Trial outcomes
Primary outcomes
Operating time
Total time for the procedure
Secondary outcomes
Wound Cosmesis
A digital photograph of the incision will be obtained on wound check visit POD 5-10 days and 4-6 weeks post partum. 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.
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.
Other outcomes
Number of Adverse Events
Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
Number of participants with any unscheduled postpartum visit
Any additional postpartum clinic appointments for medical or clinical concerns beyond the routinely scheduled visits. Participants are counted once, regardless of number or type of visits
Skin Closure Time in Minutes
Minutes it takes for closure of the skin at time of surgery
Sponsors and contacts
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