A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond
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
Dawn Tasillo
Assistant Professor
University of Massachusetts, Worcester
