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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00524511
• Other study ID #: 12462
• Status: Terminated
• Phase: N/A
• First received: August 31, 2007
• Last updated: January 24, 2013
• Start date: September 2007
• Est. completion date: May 2012

Study information

• Verified date: January 2013
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria:

• Prisoners

• Insulin-requiring diabetics

• Vertical skin incision

• Allergy to Dermabond

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Device:
• Surgical skin staples
Standard method to close abdominal surgical wounds
• Dermabond
Alternative method (superglue) to close abdominal surgical wounds

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Complication Rate	Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound	within six weeks of study intervention	Yes
Secondary	Patient Satisfaction of Cosmesis of Surgical Wound	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)	before hospital discharge after surgery	No