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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Waggonner, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01313754
First received: March 10, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  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 Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Pain
U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cosmesis at the incision sites [ Time Frame: The patients will be assessed at their 2nd week post operative visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Waggonner, MD, M.D., Loma Linda University
ClinicalTrials.gov Identifier: NCT01313754     History of Changes
Other Study ID Numbers: DWSS-01
Study First Received: March 10, 2011
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Pelvic Pain
Postoperative Complications
 Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013