A Study Comparing Two Different Techniques for Closing the Skin After a Cesarean Delivery
Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Post operative pain
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Secondary Outcome Measures
Outcome Measure |
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Patient Satisfaction
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Costs
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Cosmetic outcome
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Infection rate
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Length of time of skin closure
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Wound disruption rate
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason K. Baxter, MD, MSCP, Thomas Jefferson University
Publications and helpful links
General 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.
- Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577.
- 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. doi: 10.2460/ajvr.2005.66.1975.
- Ranaboldo CJ, Rowe-Jones DC. Closure of laparotomy wounds: skin staples versus sutures. Br J Surg. 1992 Nov;79(11):1172-3. doi: 10.1002/bjs.1800791122.
- 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. doi: 10.1002/bjs.1800700414.
- 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 record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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