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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293683
Recruitment Status : Unknown
Verified July 2014 by Thomas Jefferson University.
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2006
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cesarean Section Device: Insorb absorbable skin staple Not Applicable

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.


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.


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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples
Study Start Date : December 2004
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Primary Outcome Measures :
  1. Post operative pain

Secondary Outcome Measures :
  1. Length of time of skin closure
  2. Costs
  3. Cosmetic outcome
  4. Wound disruption rate
  5. Infection rate
  6. Patient Satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293683

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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
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Principal Investigator: Jason K. Baxter, MD, MSCP Thomas Jefferson University
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Responsible Party: Thomas Jefferson University Identifier: NCT00293683    
Other Study ID Numbers: 04U.498
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by Thomas Jefferson University: