Staples Versus Suture for Cesarean Wound Closure

Wound Clinical Trial

— SVS  

Official title:

Surgical Staples vs. Absorbable Subcuticular Suture for Wound Closure of Cesarean Deliveries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01008449
• Other study ID #: X090531008
• Status: Terminated
• Phase: N/A
• First received: November 4, 2009
• Last updated: September 2, 2014
• Start date: August 2009
• Est. completion date: February 2011

Study information

• Verified date: September 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 398
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound

Intervention

Device:
• Surgical staples
Surgical staples will be used once for wound closure.
• Absorbable Surgical Suture
Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.

Locations

Country	Name	City	State
United States	UAB Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (3)

Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD003577. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Subjects With Composite Wound Morbidity.	this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed	4-6 weeks post partum	Yes
Secondary	Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))	The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).	at the end of follow up, 4 - 6 weeks post partum	No
Secondary	Operative Procedure Time.	time for procedure as measured in minutes	Intraoperative, at time of intervention.	No
Secondary	Post Operative Pain - 4 - 6 Weeks Post Delivery	the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress	at end of follow-up, 4 - 6 weeks post partum	No
Secondary	Post Operative Pain - 72 - 96 Hours Post Delivery	the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress	72 - 96 hours post delivery	No
Secondary	Subject Reported Satisfaction With Appearance of Scar	Subject reported satisfaction of the scar appearance was assessed by using a scale of 1 - 5 with 1 being worst appearance and 5 being best appearance	4 - 6 weeks post delivery	No
Secondary	Subject Satisfaction With Comfort With Scar	Scar discomfort satisfaction was reported by subject perception using a scale of 1 - 5. A score of 1 would be the worst comfort and a score of 5 would be the best comfort	at end of follow-up, 4 - 6 weeks post partum	No
Secondary	Subject Satisfaction With Location of Scar	Satisfaction with location of scar was reported by subject using a scale of 1 - 5. A score of 1 would be the worst location of a scar and a score of 5 would be the best location of a scar	at end of follow-up, 4 - 6 weeks post partum	No

External Links

•   Link to study results on PubMed