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Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00524511
Recruitment Status : Terminated (Poor enrollment, much data was missing as patients were lost to follow up)
First Posted : September 3, 2007
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Dawn Tasillo, University of Massachusetts, Worcester

Study Description
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Brief Summary:
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.

Condition or disease Intervention/treatment Phase
Cesarean Section Device: Surgical skin staples Device: Dermabond Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond
Study Start Date : September 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dermabond

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Women receiving Dermabond for skin closure
 Device: Surgical skin staples
Standard method to close abdominal surgical wounds
Active Comparator: 2
Women receiving standard surgical skin staples
 Device: Dermabond
Alternative method (superglue) to close abdominal surgical wounds
Other Name: Tissue adhesive


Outcome Measures
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Primary Outcome Measures :
  1. Wound Complication Rate [ Time Frame: within six weeks of study intervention ]
    Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound


Secondary Outcome Measures :
  1. Patient Satisfaction of Cosmesis of Surgical Wound [ Time Frame: before hospital discharge after surgery ]
    survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria:

  • Prisoners
  • Insulin-requiring diabetics
  • Vertical skin incision
  • Allergy to Dermabond
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524511


Locations
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United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01604
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Dawn S Tasillo, MD University of Massachusetts, Worcester
More Information
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Responsible Party: Dawn Tasillo, Assistant Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00524511    
Other Study ID Numbers: 12462
First Posted: September 3, 2007    Key Record Dates
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013
Last Verified: January 2013
Keywords provided by Dawn Tasillo, University of Massachusetts, Worcester:
cesarean
wound
Dermabond
 superglue
staples
wound complications