A Study Comparing Two Different Techniques for Closing the Skin After a Cesarean Delivery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples|
- Post operative pain
- Length of time of skin closure
- Cosmetic outcome
- Wound disruption rate
- Infection rate
- Patient Satisfaction
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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.
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.
The cesarean delivery should be performed in the usual fashion according to the surgeon's preference.
- Skin is prepped with a suitable antibacterial agent
- Appropriate prophylactic antibiotics
- Bladder flap should not be routinely created or closed
- Uterus may be closed in 1 or 2 layers
- Peritoneum should not be routinely closed
- Skin wound should be irrigated after fascia closure
- Subcutaneous drains or sutures at surgeon's discretion
- Steri-strips will be placed prior to dressing placement in the OR
- Dressing removal on POD #1
- Metal staple removal prior to discharge from hospital preferred, but ultimately up to surgeon's discretion
Skin incisions will be closed with the assigned stapling device. Addison tissue forceps will be used to evert the skin edges. The recommended distance between staples is 8 to 10mm; however this can be altered at the discretion of the operating physician.
The subject's age, race, gravidity, parity, reported weight, indication for cesarean delivery, medical co-morbidity, delivery associated complications and findings, charted pain medication and clinic status will be assessed by chart review. Pain, time of placement, patient satisfaction, and cosmetic outcome will be assessed by data sheets filled out by the OR staff, physicians, and patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293683
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jason K. Baxter, MD, MSCP||Thomas Jefferson University|