Staples Versus Suture for Cesarean Wound Closure (SVS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Surgical Staples vs. Absorbable Subcuticular Suture for Wound Closure of Cesarean Deliveries|
- Percent of Subjects With Composite Wound Morbidity. [ Time Frame: 4-6 weeks post partum ] [ Designated as safety issue: Yes ]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
- Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES)) [ Time Frame: at the end of follow up, 4 - 6 weeks post partum ] [ Designated as safety issue: No ]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).
- Operative Procedure Time. [ Time Frame: Intraoperative, at time of intervention. ] [ Designated as safety issue: No ]time for procedure as measured in minutes
- Post Operative Pain - 4 - 6 Weeks Post Delivery [ Time Frame: at end of follow-up, 4 - 6 weeks post partum ] [ Designated as safety issue: No ]the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress
- Post Operative Pain - 72 - 96 Hours Post Delivery [ Time Frame: 72 - 96 hours post delivery ] [ Designated as safety issue: No ]the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress
- Subject Reported Satisfaction With Appearance of Scar [ Time Frame: 4 - 6 weeks post delivery ] [ Designated as safety issue: No ]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
- Subject Satisfaction With Comfort With Scar [ Time Frame: at end of follow-up, 4 - 6 weeks post partum ] [ Designated as safety issue: No ]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
- Subject Satisfaction With Location of Scar [ Time Frame: at end of follow-up, 4 - 6 weeks post partum ] [ Designated as safety issue: No ]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
|Study Start Date:||August 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Absorbable Subcuticular Surgical Suture
Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.
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: Surgical staples
Patients in this arm will receive surgical staples for wound closure.
Device: Surgical staples
Surgical staples will be used once for wound closure.
Other Name: Proximate Plus MD 35 W, Ethicon Endo-surgery
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.)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008449
|United States, Alabama|
|Birmingham, Alabama, United States, 35249|
|Principal Investigator:||Dana Figueroa, MD||University of Alabama at Birmingham|