A Study Comparing Two Different Techniques for Closing the Skin After a Cesarean Delivery - Full Text View

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00293683

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

MedlinePlus related topics: Cesarean Section Cosmetics

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples

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:	June 2006

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

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

More Information

Publications:

Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.

Ranaboldo CJ, Rowe-Jones DC. Closure of laparotomy wounds: skin staples versus sutures. Br J Surg. 1992 Nov;79(11):1172-3.

Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. Review.

Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84.

Pickford IR, Brennan SS, Evans M, Pollock AV. Two methods of skin closure in abdominal operations: a controlled clinical trial. Br J Surg. 1983 Apr;70(4):226-8.

Zwart HJ, de Ruiter P. Subcuticular, continuous and mechanical skin closure: cosmetic results of a prospective randomized trial. Neth J Surg. 1989 Jun;41(3):57-60. No abstract available.

Study ID Numbers:	04U.498
Study First Received:	February 16, 2006
Last Updated:	February 16, 2006
ClinicalTrials.gov Identifier:	NCT00293683 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:

cesarean
closure
skin

staple
absorbable
metal

ClinicalTrials.gov processed this record on May 07, 2009