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
  Purpose

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 Intervention
Cesarean Section
Device: Surgical skin staples
Device: Dermabond

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 136
Study Start Date: September 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524511

Locations
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01604
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Dawn S Tasillo, MD University of Massachusetts School of Medicine
  More Information

No publications provided

Responsible Party: Dawn Tasillo, Assistant Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00524511     History of Changes
Other Study ID Numbers: 12462
Study First Received: August 31, 2007
Results First Received: October 24, 2012
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
cesarean
wound
Dermabond
superglue
staples
wound complications

ClinicalTrials.gov processed this record on October 20, 2014