Clinical trial NCT01008449: Staples Versus Suture for Cesarean Wound Closure
Official title: Surgical Staples vs. Absorbable Subcuticular Suture for Wound Closure of Cesarean Deliveries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound
Keywords: Staples
Sutures
Cesarean Delivery
Wound
Skin Closure
Wound infection
Wound disruption
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-11-05
Enrollment: 398
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Subjects With Composite Wound Morbidity.
timeFrame: 4-6 weeks post partum
Secondary outcomes:
measure: Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))
timeFrame: at the end of follow up, 4 - 6 weeks post partum
measure: Operative Procedure Time.
timeFrame: Intraoperative, at time of intervention.
measure: Post Operative Pain - 4 - 6 Weeks Post Delivery
timeFrame: at end of follow-up, 4 - 6 weeks post partum
measure: Post Operative Pain - 72 - 96 Hours Post Delivery
timeFrame: 72 - 96 hours post delivery
measure: Subject Reported Satisfaction With Appearance of Scar
timeFrame: 4 - 6 weeks post delivery
measure: Subject Satisfaction With Comfort With Scar
timeFrame: at end of follow-up, 4 - 6 weeks post partum
measure: Subject Satisfaction With Location of Scar
timeFrame: at end of follow-up, 4 - 6 weeks post partum
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Dana Figueroa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.
citation: Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
citation: 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.
citation: Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.