SVS: Staples Versus Suture for Cesarean Wound Closure

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01008449
• Collaborator: (none)
• Enrollment: 398
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 22.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound	Device: Surgical staples; Device: Absorbable Surgical Suture	N/A

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.)

Study Design

• Study Type: Interventional
• Actual Enrollment: 398 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Staples vs. Absorbable Subcuticular Suture for Wound Closure of Cesarean Deliveries
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Proximate Plus MD 35 W, Ethicon Endo-surgery

Outcome Measures

Primary Outcome Measures

1. Percent of Subjects With Composite Wound Morbidity. [4-6 weeks post partum]

   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

Secondary Outcome Measures

1. Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES)) [at the end of follow up, 4 - 6 weeks post partum]

   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).

2. Operative Procedure Time. [Intraoperative, at time of intervention.]

   time for procedure as measured in minutes

3. Post Operative Pain - 4 - 6 Weeks Post Delivery [at end of follow-up, 4 - 6 weeks post partum]

   the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress

4. Post Operative Pain - 72 - 96 Hours Post Delivery [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

5. Subject Reported Satisfaction With Appearance of Scar [4 - 6 weeks post delivery]

   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

6. Subject Satisfaction With Comfort With Scar [at end of follow-up, 4 - 6 weeks post partum]

   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

7. Subject Satisfaction With Location of Scar [at end of follow-up, 4 - 6 weeks post partum]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Hospital	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Dana Figueroa, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to study results on PubMed

Publications

• 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.
• Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
• 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.

• Responsible Party: Alan Tita, Physician, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01008449
• Other Study ID Numbers: X090531008
• First Posted: Nov 5, 2009
• Last Update Posted: Sep 3, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Alan Tita, Physician, University of Alabama at Birmingham: Staples; Sutures; Cesarean Delivery; Wound; Skin Closure; Wound infection; Wound disruption
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Period Title: Overall Study
STARTED	200	198
COMPLETED	171	179
NOT COMPLETED	29	19

Baseline Characteristics

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples	Total
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.	Total of all reporting groups
Overall Participants	171	179	350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.9 (5.9)	26.7 (6.1)	26.8 (6.0)
Sex: Female, Male (Count of Participants)
Female	171 100%	179 100%	350 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	171 100%	179 100%	350 100%

Outcome Measures

1. Primary Outcome

Title	Percent of Subjects With Composite Wound Morbidity.
Description	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
Time Frame	4-6 weeks post partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Number [percentage of subjects]	5.9	14.5

2. Secondary Outcome

Title	Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))
Description	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).
Time Frame	at the end of follow up, 4 - 6 weeks post partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Median (Inter-Quartile Range) [units on a scale]	4	3

3. Secondary Outcome

Title	Operative Procedure Time.
Description	time for procedure as measured in minutes
Time Frame	Intraoperative, at time of intervention.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Median (Inter-Quartile Range) [minutes]	40	37

4. Secondary Outcome

Title	Post Operative Pain - 4 - 6 Weeks Post Delivery
Description	the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress
Time Frame	at end of follow-up, 4 - 6 weeks post partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Median (Inter-Quartile Range) [units on a scale]	0	0

5. Secondary Outcome

Title	Post Operative Pain - 72 - 96 Hours Post Delivery
Description	the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress
Time Frame	72 - 96 hours post delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Median (Inter-Quartile Range) [units on a scale]	5	5

6. Secondary Outcome

Title	Subject Reported Satisfaction With Appearance of Scar
Description	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
Time Frame	4 - 6 weeks post delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Median (Inter-Quartile Range) [units on a scale]	4	4

7. Secondary Outcome

Title	Subject Satisfaction With Comfort With Scar
Description	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
Time Frame	at end of follow-up, 4 - 6 weeks post partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Median (Inter-Quartile Range) [units on a scale]	4	4

8. Secondary Outcome

Title	Subject Satisfaction With Location of Scar
Description	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
Time Frame	at end of follow-up, 4 - 6 weeks post partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Absorbable Subcuticular Surgical Suture	Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Measure Participants	171	179
Median (Inter-Quartile Range) [units on a scale]	4	4

Adverse Events

Arm/Group Title	Absorbable Subcuticular Surgical Suture		Surgical Staples
Arm/Group Description	Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.		Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
All Cause Mortality
	Absorbable Subcuticular Surgical Suture		Surgical Staples
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Absorbable Subcuticular Surgical Suture		Surgical Staples
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/171 (0%)		0/179 (0%)
Other (Not Including Serious) Adverse Events
	Absorbable Subcuticular Surgical Suture		Surgical Staples
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/171 (7%)		28/179 (15.6%)
Infections and infestations
infection at 4 - 6 weeks post delivery	6/171 (3.5%)		4/179 (2.2%)
Skin and subcutaneous tissue disorders
disruption of wound at 4 - 6 weeks post delivery	6/171 (3.5%)		24/179 (13.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.