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Staples Versus Suture for Cesarean Wound Closure (SVS)

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ClinicalTrials.gov Identifier: NCT01008449
Recruitment Status : Terminated (New studies were reporting that sutures are beneficial, hindering the possibility of enrollment.)
First Posted : November 5, 2009
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Wound
Interventions Device: Surgical staples
Device: Absorbable Surgical Suture
Enrollment 398
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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
Reason Not Completed
Lost to Follow-up             29             19
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples Total
Hide 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 Number of Baseline Participants 171 179 350
Hide Baseline Analysis Population Description
subjects that that were lost to follow up were not included in the results
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants 179 participants 350 participants
26.9  (5.9) 26.7  (6.1) 26.8  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 179 participants 350 participants
Female
171
 100.0%
179
 100.0%
350
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 171 participants 179 participants 350 participants
171 179 350
1.Primary Outcome
Title Percent of Subjects With Composite Wound Morbidity.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Measure Type: Number
Unit of Measure: percentage of subjects
5.9 14.5
2.Secondary Outcome
Title Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(3 to 5)
3
(3 to 4)
3.Secondary Outcome
Title Operative Procedure Time.
Hide Description time for procedure as measured in minutes
Time Frame Intraoperative, at time of intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Median (Inter-Quartile Range)
Unit of Measure: minutes
40
(28 to 55)
37
(29 to 53)
4.Secondary Outcome
Title Post Operative Pain - 4 - 6 Weeks Post Delivery
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 2)
0
(0 to 1)
5.Secondary Outcome
Title Post Operative Pain - 72 - 96 Hours Post Delivery
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(4 to 7)
5
(3 to 7)
6.Secondary Outcome
Title Subject Reported Satisfaction With Appearance of Scar
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(4 to 5)
4
(4 to 5)
7.Secondary Outcome
Title Subject Satisfaction With Comfort With Scar
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(4 to 5)
4
(4 to 5)
8.Secondary Outcome
Title Subject Satisfaction With Location of Scar
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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.

Overall Number of Participants Analyzed 171 179
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(4 to 5)
4
(4 to 5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Absorbable Subcuticular Surgical Suture Surgical Staples
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Absorbable Subcuticular Surgical Suture Surgical Staples
Affected / at Risk (%) Affected / at Risk (%)
Total   0/171 (0.00%)   0/179 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Absorbable Subcuticular Surgical Suture Surgical Staples
Affected / at Risk (%) Affected / at Risk (%)
Total   12/171 (7.02%)   28/179 (15.64%) 
Infections and infestations     
infection at 4 - 6 weeks post delivery *  6/171 (3.51%)  4/179 (2.23%) 
Skin and subcutaneous tissue disorders     
disruption of wound at 4 - 6 weeks post delivery *  6/171 (3.51%)  24/179 (13.41%) 
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: UAB
Phone: 205-934-3411
EMail: dana_figueroa_marzilli@hotmail.com
Layout table for additonal information
Responsible Party: Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01008449    
Other Study ID Numbers: X090531008
First Submitted: November 4, 2009
First Posted: November 5, 2009
Results First Submitted: July 15, 2014
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014