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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:
ClinicalTrials.gov Identifier:
NCT00524511
First Posted: September 3, 2007
Last Update Posted: March 5, 2013
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.
Information provided by (Responsible Party):
Dawn Tasillo, University of Massachusetts, Worcester
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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)


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

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.


Ages Eligible for Study:   Child, Adult, Senior
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
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
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, Worcester
  More Information

Responsible Party: Dawn Tasillo, Assistant Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00524511     History of Changes
Other Study ID Numbers: 12462
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: October 24, 2012
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