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

Not Applicable

Terminated

• Conditions: Cesarean Section
• Interventions: Device: Surgical skin staples; Device: Dermabond

• Registration Number: NCT00524511
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study Start: 2007-09
• Study First Posted: 2007-09-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2012-10-24
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-24
• Last Update Submitted: 2013-01-24
• Results First Posted: 2013-03-05
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Surgical skin staples	Women receiving Dermabond for skin closure
2	Dermabond	Women receiving standard surgical skin staples

Primary Outcome Measures

Name	Time	Method
Wound Complication Rate	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

Name	Time	Method
Patient Satisfaction of Cosmesis of Surgical Wound	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)

Trial Locations

Locations (1)

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States