NCT00466648

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2007

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

April 25, 2007

Last Update Submit

April 25, 2007

Conditions

Laparoscopic Cosmesis

Keywords

laparoscopy, port site, closure, Dermabond

Interventions

Tissue adhesivePROCEDURE

Eligibility Criteria

Age16 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • gynecologic laparoscopy patients

You may not qualify if:

  • known sensitivity to tissue adhesive, antibiotic ointment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesSurgical Fixation DevicesSurgical EquipmentEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Giuseppe Del Priore

    New York Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

March 1, 2007

Study Completion

April 1, 2007

Last Updated

April 27, 2007

Record last verified: 2007-04