Staples Versus Suture for Cesarean Wound Closure

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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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.

The study was terminated after recruitment of approximately 400 subjects after administrative review (see publication: Figueroa et al. Obstet Gynecol. 2013 Jan;121(1):33-8.)

Conditions

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Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Absorbable Subcuticular Surgical Suture

Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.

Group Type ACTIVE_COMPARATOR

Absorbable Surgical Suture

Intervention Type DEVICE

Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.

Surgical staples

Patients in this arm will receive surgical staples for wound closure.

Group Type ACTIVE_COMPARATOR

Surgical staples

Intervention Type DEVICE

Surgical staples will be used once for wound closure.

Interventions

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Surgical staples

Surgical staples will be used once for wound closure.

Intervention Type DEVICE

Absorbable Surgical Suture

Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.

Intervention Type DEVICE

Other Intervention Names

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Proximate Plus MD 35 W, Ethicon Endo-surgery 4-0 Monocryl, Ethicon

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No