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

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT01313754
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
19.1
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Vicryl Suture
  • Procedure: Dermabond
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The level of severity of patient discomfort at their incision sites. [The patients will be assessed at their second week post operative visit.]

    Secondary Outcome Measures

    1. Cosmesis at the incision sites [The patients will be assessed at their 2nd week post operative visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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.,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Waggonner, MD, M.D., Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT01313754
    Other Study ID Numbers:
    • DWSS-01
    First Posted:
    Mar 14, 2011
    Last Update Posted:
    Jan 31, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by David Waggonner, MD, M.D., Loma Linda University
    Skin closure
    dermabond
    vicryl
    monocryl
    Suburethral sling
    Transobturator Sling
    Pain
    Discomfort
    Skin irritation
    Additional relevant MeSH terms:
    Pain, Postoperative
    Pelvic Pain

    Study Results

    No Results Posted as of Jan 31, 2013