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Wound Closure Techniques

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hartford Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00282633
First received: January 25, 2006
Last updated: October 30, 2007
Last verified: October 2007
History of Changes
  Purpose

A Comparison of Skin Closure Techniques after Primary Cesarean Delivery. Traci N. Gray, M.D. and Peter F. Schnatz, D.O.

A prospective, observer blinded, randomized, and controlled trial comparing Dermabond closure technique to suture closure of skin.

Study Participants: All women age 18years or older who provide informed consent prior to primary Cesarean delivery at Hartford Hospital. Women with vertical skin incisions and or who are febrile preop or intraop will be excluded.

Methods: Qualified participants will then be randomized to skin closure with either Dermabond or suture. Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin closure for patients randomized to the suture arm.

  • The circulating nurse will time all skin closures.
  • The surgeon will complete a 3 question survey immediately postop.
  • At the 6 week post partum visit, patients and the health care professional will complete a brief query regarding cosmetic appeal and pain. A disposable camera will be supplied to each provider office and a photo will be taken of the incision.
  • All photos will be evaluated for cosmesis by physicians who will be blinded to the methods of skin closure.

Primary Outcomes: To compare the time needed to close skin. To compare cosmetic outcome after healing

Secondary Outcomes: Patient Pain scores. Provider and patient satisfaction. Responses to questions.


Condition Intervention
Wounds, Closure
 Device: Dermabond

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Skin Closure Techniques After Primary Cesarean Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Time needed to close skin.
  • Cosmetic outcome after healing

Secondary Outcome Measures:
  • Patient Pain scores.
  • Provider and patient satisfaction.
  • Responses to questions.

Estimated Enrollment: 120
Study Start Date: November 2005
Estimated Study Completion Date: December 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing a primary Cesarean Delivery
  • Eighteen years of age or older

Exclusion Criteria:

  • Allergy to Dermabond
  • Fever pre or intra operatively
  • The need for a vertical skin incision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282633

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Traci Gray, M.D.     860-825-4623        
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Peter F. Schnatz, D.O. Hartford Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00282633     History of Changes
Other Study ID Numbers: SCHN001820HU
Study First Received: January 25, 2006
Last Updated: October 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:
Cesarean Delivery
Wound closure
Suture
Alternative therapy
Surgery

ClinicalTrials.gov processed this record on June 13, 2013