Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Thomas Jefferson University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Post operative pain
Study Overview
Brief Summary
We hypothesize that the use of absorbable staples to close cesarean skin incisions will cause less pain, have better long-term cosmetic results, and result in improved patient satisfaction over standard metal staples. We expect to see no difference in wound complication rates with these two cesarean skin closure techniques.
Detailed Description
Type: Randomized controlled trial
Selection of Patients: All pregnant women, undergoing a primary (their first) cesarean delivery at Thomas Jefferson University Hospital will be offered randomization regardless of indication for cesarean delivery. Patients will be excluded from the study if they have a history of a previous cesarean delivery, history of a previous Pfannensteil skin incision for an indication other than for a cesarean delivery (i.e. myomectomy, laparotomy), or a planned vertical skin incision prior to randomization.
Randomization:
Patients will be randomized to skin closure with either the standard staples or the Insorb™ absorbable staple using a computer-generated random number sequence in blocks of six and ten. Allocation will be concealed in opaque, sealed study envelopes that are held on labor and delivery until after consent is obtained. Patients will not be masked as to the type of stapler used however, the investigator obtaining outcome data at six months will be masked.
Procedure:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 12 Years to 55 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients at TJUH undergoing primary cesarean delivery via Pfannenstiel incision
- •Surgeon willing to adhere to randomized skin staple category
Exclusion Criteria
- •Known allergy to staples or suture
- •Vertical skin incision
- •Repeat cesarean deliveries
Outcomes
Primary Outcomes
Post operative pain
Secondary Outcomes
- Length of time of skin closure
- Costs
- Cosmetic outcome
- Wound disruption rate
- Infection rate
- Patient Satisfaction