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

Pain, Postoperative Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313754
• Other study ID #: DWSS-01
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: January 29, 2013
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Those patients receiving a transobturator suburethral sling procedure.

• Adults (>= 18years).

Exclusion Criteria:

• Non-English speaking.

• Allergy to monocryl, vicryl, or dermabond.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritation (Physical)
• Pain, Postoperative
• Pelvic Pain

Intervention

Procedure:
• Vicryl Suture
Vicryl suture material will be placed on the patients left sided incision.
• Dermabond
Dermabond skin glue will be placed on the patients left sided incision.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of severity of patient discomfort at their incision sites.		The patients will be assessed at their second week post operative visit.	No
Secondary	Cosmesis at the incision sites		The patients will be assessed at their 2nd week post operative visit	No