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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00293683
First received: February 16, 2006
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cesarean Section
Device: Insorb absorbable skin staple

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Post operative pain

Secondary Outcome Measures:
  • Length of time of skin closure
  • Costs
  • Cosmetic outcome
  • Wound disruption rate
  • Infection rate
  • Patient Satisfaction

Estimated Enrollment: 120
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)
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.

  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293683

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Jason K. Baxter, MD, MSCP Thomas Jefferson University