Staples Versus Suture for Cesarean Wound Closure (SVS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01008449
First received: November 4, 2009
Last updated: January 12, 2014
Last verified: January 2014

November 4, 2009
January 12, 2014
August 2009
February 2011   (final data collection date for primary outcome measure)
Composite wound morbidity. [ Time Frame: 4-6 weeks post partum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01008449 on ClinicalTrials.gov Archive Site
  • Patient satisfaction. [ Time Frame: 4-6 weeks post partum ] [ Designated as safety issue: No ]
  • Cosmesis [ Time Frame: 4-6 weeks post partum ] [ Designated as safety issue: No ]
  • Operative procedure time. [ Time Frame: Intraoperative, at time of intervention. ] [ Designated as safety issue: No ]
  • Post-operative pain [ Time Frame: POD 3 and 4-6 weeks post-op ] [ Designated as safety issue: No ]
  • Patient satisfaction. [ Time Frame: 4-6 weeks post partum ] [ Designated as safety issue: No ]
  • Cosmesis [ Time Frame: 4-6 weeks post partum ] [ Designated as safety issue: No ]
  • Health service use. [ Time Frame: 4-6 weeks post partum ] [ Designated as safety issue: No ]
  • Operative procedure time. [ Time Frame: Intraoperative, at time of intervention. ] [ Designated as safety issue: No ]
  • Post-operative pain [ Time Frame: POD 3 and 4-6 weeks post-op ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Staples Versus Suture for Cesarean Wound Closure
Surgical Staples vs. Absorbable Subcuticular Suture for Wound Closure of Cesarean Deliveries

The objective of this randomized controlled trial is to compare wound morbidity (including disruption and infection) in surgical staples versus absorbable subcuticular suture for wound closure in cesarean deliveries.

Cesarean delivery (CD) is a common surgical procedure with over 1 million performed annually in the United States. The rate of CD is steadily increasing. In 2006, an estimated 31.1% of U.S. births were by CD. Approximately two thirds of these are primary procedures and 90% of CD will later undergo a repeat cesarean delivery. The rise in CD has been attributed to changes in physician and patient expectations, attitudes about risk, and changes in clinical practice. These include decreased vaginal birth after cesarean delivery (VBAC), breech vaginal deliveries, and operative vaginal deliveries as well as an increase in maternal request, failed induction of labor, and elective repeat CD. The CD rate is expected to rise as high as 40-50% in the next decade if the increasing trend continues unabated.

Despite the large number of CD performed, there is no agreed standard for skin closure. The most commonly used materials are surgical staples and absorbable subcuticular suture. Staples have a clear benefit in decreasing operating time. In theory, staples also have a decreased chance of bacterial migration into the wound, decreased tension at the incision edges, and less damage to capillaries in the subcuticular layer of skin than absorbable subcuticular suture. However, some argue that staples are more painful and have a worse cosmetic appearance. This is especially the case for staples that remain in place longer than recommended and leave "track marks." Staples are also less visually appealing to patients.

The Cochrane Collaboration identified one randomized controlled trial (RCT) that addressed skin closure for CD (Alderice, 2003). This study included 66 women and compared absorbable subcuticular suture versus surgical staples for skin closure of CD. Surgical staples had shorter operating time but absorbable subcuticular suture had decreased post-operative pain and better cosmesis at the 6 week post-operative visit (Frishman, 1997). Rousseau, J. presented opposing findings in her RCT "A Randomized Study Comparing Subcuticular Sutures Versus Staples for Skin Closure at Cesarean Sections". In this study, staples had better cosmesis, decreased pain at the post-operative visit, and shorter operating time (Rousseau, 2009). Neither study assessed wound disruption or infection directly. With such widely varying findings and lack of data there is a need to identify the cesarean section skin closure which provides the best outcomes for the most common major surgical procedure in women.

We have undertaken a RCT to compare surgical staples vs. absorbable subcuticular suture for the closure of the skin in cesarean sections. Our primary outcome is a composite wound morbidity outcome (including wound disruption or infection). Assuming a baseline wound morbidity of 8%, Power of 80%, and a decrease of wound morbidity to 4%, a sample size of 1,204 will be required. Our secondary outcomes will include cosmesis, post-operative pain, health service use/cost, procedure time, and patient satisfaction.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Wound
  • Device: Surgical staples
    Surgical staples will be used once for wound closure.
    Other Name: Proximate Plus MD 35 W, Ethicon Endo-surgery
  • Device: Absorbable Surgical Suture
    Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.
    Other Name: 4-0 Monocryl, Ethicon
  • Active Comparator: Absorbable Subcuticular Surgical Suture
    Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
    Intervention: Device: Absorbable Surgical Suture
  • Active Comparator: Surgical staples
    Patients in this arm will receive surgical staples for wound closure.
    Intervention: Device: Surgical staples

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • cesarean delivery

Exclusion Criteria:

  • chronic use of immunosuppressive agents ( e.g.po steroids > 2 weeks)
  • significant immune compromising disease (e.g. AIDS, CD4<200)
  • contraindication to standard post operative pain management (acetaminophen, ibuprofen, oxycodone)
  • refusal or inability to give consent
Female
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01008449
X090531008
Yes
University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Dana Figueroa, MD University of Alabama at Birmingham
University of Alabama at Birmingham
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP