Staples Versus Suture for Cesarean Wound Closure (SVS)

This study has been terminated.
(New studies were reporting that sutures are beneficial, hindering the possibility of enrollment.)
Sponsor:
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01008449
First received: November 4, 2009
Last updated: September 2, 2014
Last verified: September 2014
Results First Received: July 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Wound
Interventions: Device: Surgical staples
Device: Absorbable Surgical Suture

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Absorbable Subcuticular Surgical Suture

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.

Surgical Staples

Patients in this arm will receive surgical staples for wound closure.

Surgical staples: Surgical staples will be used once for wound closure.


Participant Flow:   Overall Study
    Absorbable Subcuticular Surgical Suture     Surgical Staples  
STARTED     200     198  
COMPLETED     171     179  
NOT COMPLETED     29     19  
Lost to Follow-up                 29                 19  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
subjects that that were lost to follow up were not included in the results

Reporting Groups
  Description
Absorbable Subcuticular Surgical Suture

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.

Surgical Staples

Patients in this arm will receive surgical staples for wound closure.

Surgical staples: Surgical staples will be used once for wound closure.

Total Total of all reporting groups

Baseline Measures
    Absorbable Subcuticular Surgical Suture     Surgical Staples     Total  
Number of Participants  
[units: participants]
  171     179     350  
Age  
[units: years]
Mean ± Standard Deviation
  26.9  ± 5.9     26.7  ± 6.1     26.8  ± 6.0  
Gender  
[units: participants]
     
Female     171     179     350  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     171     179     350  



  Outcome Measures
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1.  Primary:   Percent of Subjects With Composite Wound Morbidity.   [ Time Frame: 4-6 weeks post partum ]

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

3.  Secondary:   Operative Procedure Time.   [ Time Frame: Intraoperative, at time of intervention. ]

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

5.  Secondary:   Post Operative Pain - 72 - 96 Hours Post Delivery   [ Time Frame: 72 - 96 hours post delivery ]

6.  Secondary:   Subject Reported Satisfaction With Appearance of Scar   [ Time Frame: 4 - 6 weeks post delivery ]

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

8.  Secondary:   Subject Satisfaction With Location of Scar   [ Time Frame: at end of follow-up, 4 - 6 weeks post partum ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Principal Investigator
Organization: UAB
phone: 205-934-3411
e-mail: dana_figueroa_marzilli@hotmail.com


Publications:

Responsible Party: Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01008449     History of Changes
Other Study ID Numbers: X090531008
Study First Received: November 4, 2009
Results First Received: July 15, 2014
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board