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

NCT01313754 | Completed DMC

• 1 other identifier: DWSS-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Irritation (Physical); Pelvic Pain

Keywords

Skin closure; dermabond; vicryl; monocryl; Suburethral sling; Transobturator Sling; Pain; Discomfort; Skin irritation

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Cosmesis at the incision sites

  The patients will be assessed at their 2nd week post operative visit

Study Arms (2)

Vicryl

OTHER

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

Dermabond

EXPERIMENTAL

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

Interventions

Vicryl Suture PROCEDURE

Vicryl suture material will be placed on the patients left sided incision.

Also known as: polyglactin 910

Vicryl

Dermabond PROCEDURE

Dermabond skin glue will be placed on the patients left sided incision.

Also known as: 2-octyl cyanoacrylate

Dermabond

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pelvic Pain; Pain

Interventions

Polyglactin 910; octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Sam Siddighi, M.D.

  PRINCIPAL INVESTIGATOR

• David B Waggonner, M.D.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 14, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

US (1)