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

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ClinicalTrials.gov Identifier: NCT01313754
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
David Waggonner, MD, Loma Linda University

Brief Summary:
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 or disease Intervention/treatment Phase
Pain, Postoperative Irritation (Physical) Pelvic Pain Procedure: Vicryl Suture Procedure: Dermabond Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Cosmesis at the incision sites [ Time Frame: The patients will be assessed at their 2nd week post operative visit ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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.

Responsible Party: David Waggonner, MD, M.D., Loma Linda University
ClinicalTrials.gov Identifier: NCT01313754     History of Changes
Other Study ID Numbers: DWSS-01
First Posted: March 14, 2011    Key Record Dates
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