Comparison of Skin Incision Closure Material for the Transobturator Suburethral Sling Procedure

January 29, 2013 updated by: David Waggonner, MD, Loma Linda University
The purpose of this study is to compare different skin closure materials for the transobturator suburethral sling procedure. Currently the investigators are using monocryl suture material as the standard for skin closure. This material has anecdotally show to be very irritating to patients who have had this type of surgery. Our study will compare the monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate) skin glue. The investigators believe that vicryl suture material will be superior in comfort when compared to monocryl and dermabond for this type of procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Those patients receiving a transobturator suburethral sling procedure.
  • Adults (>= 18years).

Exclusion Criteria:

  • Non-English speaking.
  • Allergy to monocryl, vicryl, or dermabond.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vicryl
These patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive the vicryl material on the left.
Procedure: Vicryl Suture
Vicryl suture material will be placed on the patients left sided incision.
Other Names:
  • polyglactin 910
Experimental: Dermabond
The patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive dermabond skin glue on the left
Procedure: Dermabond
Dermabond skin glue will be placed on the patients left sided incision.
Other Names:
  • 2-octyl cyanoacrylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The level of severity of patient discomfort at their incision sites.
Time Frame: The patients will be assessed at their second week post operative visit.
The patients will be assessed at their second week post operative visit.

Secondary Outcome Measures

Outcome Measure
Time Frame
Cosmesis at the incision sites
Time Frame: The patients will be assessed at their 2nd week post operative visit
The patients will be assessed at their 2nd week post operative visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Sam Siddighi, M.D.
  • Study Director: David B Waggonner, M.D.

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

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWSS-01

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.

Clinical Trials on Pain, Postoperative

Clinical Trials on Vicryl Suture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe