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Wound Closure Techniques

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Hartford Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282633
First Posted: January 27, 2006
Last Update Posted: October 31, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hartford Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Skin Closure Techniques After Primary Cesarean Delivery

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00282633     History of Changes
Other Study ID Numbers: SCHN001820HU
First Submitted: January 25, 2006
First Posted: January 27, 2006
Last Update Posted: October 31, 2007
Last Verified: October 2007

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