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Clinical Trials/NCT00524511
NCT00524511TerminatedNot Applicable

A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond

University of Massachusetts, Worcester2 sites in 1 country136 target enrollmentStarted: September 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
136
Locations
2
Primary Endpoint
Wound Complication Rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria

  • Prisoners
  • Insulin-requiring diabetics
  • Vertical skin incision
  • Allergy to Dermabond

Outcomes

Primary Outcomes

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 Outcomes

  • Patient Satisfaction of Cosmesis of Surgical Wound(before hospital discharge after surgery)

Investigators

Sponsor
University of Massachusetts, Worcester
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dawn Tasillo

Assistant Professor

University of Massachusetts, Worcester

Study Sites (2)

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