A Study Comparing Two Different Techniques for Closing the Skin After a Cesarean Delivery

Not Applicable

• Conditions: Cesarean Section

• Registration Number: NCT00293683
• Lead Sponsor: Thomas Jefferson University

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:

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-02-16
• Study First Posted: 2006-02-17
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post operative pain

Secondary Outcome Measures

Name	Time	Method
Length of time of skin closure
Costs
Cosmetic outcome
Wound disruption rate
Infection rate
Patient Satisfaction

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States