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Wound Closure Techniques

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. Identifier: NCT00282633
Recruitment Status : Unknown
Verified October 2007 by Hartford Hospital.
Recruitment status was:  Recruiting
First Posted : January 27, 2006
Last Update Posted : October 31, 2007
Information provided by:
Hartford Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Wounds, Closure Device: Dermabond Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : November 2005
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Patient Pain scores.
  2. Provider and patient satisfaction.
  3. Responses to questions.

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

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

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 identifier (NCT number): NCT00282633

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United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Traci Gray, M.D.    860-825-4623      
Sponsors and Collaborators
Hartford Hospital
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Principal Investigator: Peter F. Schnatz, D.O. Hartford Hospital
Layout table for additonal information Identifier: NCT00282633    
Other Study ID Numbers: SCHN001820HU
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by Hartford Hospital:
Cesarean Delivery
Wound closure
Alternative therapy
Additional relevant MeSH terms:
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Wounds and Injuries