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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

Tracking Information
First Submitted Date  ICMJE August 31, 2007
First Posted Date  ICMJE September 3, 2007
Results First Submitted Date  ICMJE October 24, 2012
Results First Posted Date  ICMJE March 5, 2013
Last Update Posted Date March 5, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
Wound Complication Rate [ Time Frame: within six weeks of study intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
patient satisfaction cosmesis of surgical wound [ Time Frame: within 6 weeks of intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
Official Title  ICMJE A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cesarean Section
Intervention  ICMJE
  • Device: Surgical skin staples
    Standard method to close abdominal surgical wounds
  • Device: Dermabond
    Alternative method (superglue) to close abdominal surgical wounds
    Other Name: Tissue adhesive
Study Arms  ICMJE
  • Experimental: 1
    Women receiving Dermabond for skin closure
    Intervention: Device: Surgical skin staples
  • Active Comparator: 2
    Women receiving standard surgical skin staples
    Intervention: Device: Dermabond
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 24, 2013)
136
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2007)
230
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria:

  • Prisoners
  • Insulin-requiring diabetics
  • Vertical skin incision
  • Allergy to Dermabond
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00524511
Other Study ID Numbers  ICMJE 12462
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dawn Tasillo, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn S Tasillo, MD University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP