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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014