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Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466648
First Posted: April 27, 2007
Last Update Posted: April 27, 2007
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.
Information provided by:
New York Presbyterian Hospital
  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
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Two Different Methods of Laparoscopy Port Closure

Further study details as provided by New York Presbyterian Hospital:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00466648


Sponsors and Collaborators
New York Presbyterian Hospital
Investigators
Principal Investigator: Giuseppe Del Priore New York Presbyterian Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00466648     History of Changes
Other Study ID Numbers: HV-2007
First Submitted: April 25, 2007
First Posted: April 27, 2007
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by New York Presbyterian Hospital:
laparoscopy, port site, closure, Dermabond