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

This study has been terminated.
(Poor enrollment, much data was missing as patients were lost to follow up)
Sponsor:
Information provided by (Responsible Party):
Dawn Tasillo, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00524511
First received: August 31, 2007
Last updated: January 24, 2013
Last verified: January 2013

August 31, 2007
January 24, 2013
September 2007
May 2012   (final data collection date for primary outcome measure)
Wound Complication Rate [ Time Frame: within six weeks of study intervention ] [ Designated as safety issue: Yes ]
Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound
wound complication rate [ Time Frame: within six weeks of study intervention ]
Complete list of historical versions of study NCT00524511 on ClinicalTrials.gov Archive Site
Patient Satisfaction of Cosmesis of Surgical Wound [ Time Frame: before hospital discharge after surgery ] [ Designated as safety issue: No ]
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)
patient satisfaction cosmesis of surgical wound [ Time Frame: within 6 weeks of intervention ]
Not Provided
Not Provided
 
Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cesarean Section
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria:

  • Prisoners
  • Insulin-requiring diabetics
  • Vertical skin incision
  • Allergy to Dermabond
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00524511
12462
No
Dawn Tasillo, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Dawn S Tasillo, MD University of Massachusetts School of Medicine
University of Massachusetts, Worcester
January 2013

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