Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites

This study has been completed.
Sponsor:
Information provided by:
New York Downtown Hospital
ClinicalTrials.gov Identifier:
NCT00466648
First received: April 25, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

No publications provided

ClinicalTrials.gov Identifier: NCT00466648     History of Changes
Other Study ID Numbers: HV-2007
Study First Received: April 25, 2007
Last Updated: April 25, 2007
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 April 20, 2014