- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466648
Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites
April 25, 2007 updated by: New York Presbyterian Hospital
Randomized Controlled Trial Comparing Two Different Methods of Laparoscopy Port Closure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- gynecologic laparoscopy patients
Exclusion Criteria:
- known sensitivity to tissue adhesive, antibiotic ointment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giuseppe Del Priore, New York Presbyterian Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
April 25, 2007
First Submitted That Met QC Criteria
April 25, 2007
First Posted (Estimate)
April 27, 2007
Study Record Updates
Last Update Posted (Estimate)
April 27, 2007
Last Update Submitted That Met QC Criteria
April 25, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- HV-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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