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

NCT ID: NCT00524511

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-05-31

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Women receiving Dermabond for skin closure

Group Type: EXPERIMENTAL

Surgical skin staples

Intervention Type: DEVICE

Standard method to close abdominal surgical wounds

2

Women receiving standard surgical skin staples

Group Type: ACTIVE_COMPARATOR

Dermabond

Intervention Type: DEVICE

Alternative method (superglue) to close abdominal surgical wounds

Interventions

Surgical skin staples

Standard method to close abdominal surgical wounds

Intervention Type: DEVICE

Dermabond

Alternative method (superglue) to close abdominal surgical wounds

Intervention Type: DEVICE

Other Intervention Names

Tissue adhesive

Eligibility Criteria

Inclusion Criteria

• Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Dawn Tasillo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn S Tasillo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

12462

Identifier Type: -

Identifier Source: org_study_id