Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites

This study has been completed.

Sponsored by:	New York Downtown Hospital
Information provided by:	New York Downtown Hospital
ClinicalTrials.gov Identifier:	NCT00466648

Purpose

This study wishes to compare patient satisfaction and cosmesis of two different closure methods of laparoscopic ports. One method uses tissue adhesive (Dermabond) with a deep sub-cutaneous stitch and a Band-Aid dressing. The comparison method uses a 3.o undyed vicryl transcutaneous stitch, with a Bacitracin and Tegaderm dressing.

Condition	Intervention
Laparoscopic Cosmesis	Procedure: Tissue adhesive

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial Comparing Two Different Methods of Laparoscopy Port Closure

Further study details as provided by New York Downtown Hospital:

Estimated Enrollment:	20
Study Start Date:	March 2007
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

gynecologic laparoscopy patients

Exclusion Criteria:

known sensitivity to tissue adhesive, antibiotic ointment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466648

Sponsors and Collaborators

New York Downtown Hospital

Investigators

Principal Investigator:

Giuseppe Del Priore

New York Downtown Hospital

More Information

Study ID Numbers:	HV-2007
Study First Received:	April 25, 2007
Last Updated:	April 25, 2007
ClinicalTrials.gov Identifier:	NCT00466648
Health Authority:	United States: Institutional Review Board

Keywords provided by New York Downtown Hospital:

laparoscopy, port site, closure, Dermabond

ClinicalTrials.gov processed this record on January 15, 2009