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

NCT00524511 | Terminated Results

• 1 other identifier: 12462
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Keywords

cesarean; wound; Dermabond; superglue; staples; wound complications

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Patient Satisfaction of Cosmesis of Surgical Wound

  before hospital discharge after surgery

Study Arms (2)

1

EXPERIMENTAL

Women receiving Dermabond for skin closure

Device: Surgical skin staples

2

ACTIVE COMPARATOR

Women receiving standard surgical skin staples

Device: Dermabond

Interventions

Surgical skin staples DEVICE

Standard method to close abdominal surgical wounds

1

Dermabond DEVICE

Alternative method (superglue) to close abdominal surgical wounds

Also known as: Tissue adhesive

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01604, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dawn Tasillo, MD
• Organization: UMass Memorial Medical Center

tasillod@ummhc.org

5083346255

Study Officials

• Dawn S Tasillo, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: September 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 5, 2013
• Results First Posted: March 5, 2013

Record last verified: 2013-01

Locations

US (1)