Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites

NCT ID: NCT00466648

Last Updated: 2007-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cosmesis

Keywords

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laparoscopy, port site, closure, Dermabond

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Tissue adhesive

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* gynecologic laparoscopy patients

Exclusion Criteria

* known sensitivity to tissue adhesive, antibiotic ointment
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Giuseppe Del Priore

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital

Other Identifiers

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HV-2007

Identifier Type: -

Identifier Source: org_study_id