We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01313754
First Posted: March 14, 2011
Last Update Posted: January 31, 2013
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 (Responsible Party):
David Waggonner, MD, Loma Linda University
  Purpose
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.

Condition Intervention
Pain, Postoperative Irritation (Physical) Pelvic Pain Procedure: Vicryl Suture Procedure: Dermabond

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Further study details as provided by David Waggonner, MD, Loma Linda University:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • Cosmesis at the incision sites [ Time Frame: The patients will be assessed at their 2nd week post operative visit ]

Enrollment: 160
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 2-octyl cyanoacrylate

  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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking.
  • Allergy to monocryl, vicryl, or dermabond.
  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): NCT01313754


Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Sam Siddighi, M.D.
Study Director: David B Waggonner, M.D.
  More Information

Responsible Party: David Waggonner, MD, M.D., Loma Linda University
ClinicalTrials.gov Identifier: NCT01313754     History of Changes
Other Study ID Numbers: DWSS-01
First Submitted: March 10, 2011
First Posted: March 14, 2011
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by David Waggonner, MD, Loma Linda University:
Skin closure
dermabond
vicryl
monocryl
Suburethral sling
Transobturator Sling
Pain
Discomfort
Skin irritation

Additional relevant MeSH terms:
Pain, Postoperative
Pelvic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms