Wound Closure Techniques
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|ClinicalTrials.gov 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
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Comparison of Skin Closure Techniques After Primary Cesarean Delivery|
|Study Start Date :||November 2005|
|Estimated Study Completion Date :||December 2008|
- Time needed to close skin.
- Cosmetic outcome after healing
- Patient Pain scores.
- Provider and patient satisfaction.
- Responses to questions.
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
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|Contact: Traci Gray, M.D. 860-825-4623|
|Principal Investigator:||Peter F. Schnatz, D.O.||Hartford Hospital|