Overview

This trial is active, not recruiting.

Condition cesarean section
Treatment insorb absorbable skin staple
Sponsor Thomas Jefferson University
Start date December 2004
End date October 2014
Trial size 120 participants
Trial identifier NCT00293683, 04U.498

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Post operative pain
time frame:

Secondary Outcomes

Measure
Length of time of skin closure
time frame:
Costs
time frame:
Cosmetic outcome
time frame:
Wound disruption rate
time frame:
Infection rate
time frame:
Patient Satisfaction
time frame:

Eligibility Criteria

Female participants from 12 years up to 55 years old.

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

Additional Information

Official title Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples
Principal investigator Jason K. Baxter, MD, MSCP
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: The cesarean delivery should be performed in the usual fashion according to the surgeon's preference. We recommend: - 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. Follow Up: 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Thomas Jefferson University.