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

Primary Purpose

Pain, Postoperative, Irritation (Physical), Pelvic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vicryl Suture

Dermabond

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Skin closure, dermabond, vicryl, monocryl, Suburethral sling, Transobturator Sling, Pain, Discomfort, Skin irritation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Loma Linda University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Vicryl

Dermabond

Arm Description

These patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive the vicryl material on the left.

The patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive dermabond skin glue on the left

Outcomes

Primary Outcome Measures

The level of severity of patient discomfort at their incision sites.

Secondary Outcome Measures

Cosmesis at the incision sites

Full Information

NCT ID

NCT01313754

First Posted

March 10, 2011

Last Updated

January 29, 2013

Sponsor

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT01313754

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loma Linda University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Irritation (Physical), Pelvic Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vicryl

Arm Type

Other

Arm Description

These patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive the vicryl material on the left.

Arm Title

Dermabond

Arm Type

Experimental

Arm Description

The patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive dermabond skin glue on the left

Intervention Type

Procedure

Intervention Name(s)

Vicryl Suture

Other Intervention Name(s)

polyglactin 910

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Dermabond

Other Intervention Name(s)

2-octyl cyanoacrylate

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Cosmesis at the incision sites

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Those patients receiving a transobturator suburethral sling procedure. Adults (>= 18years). Exclusion Criteria: Non-English speaking. Allergy to monocryl, vicryl, or dermabond.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam Siddighi, M.D.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David B Waggonner, M.D.

Official's Role

Study Director

Facility Information:

Facility Name

Loma Linda University Medical Center

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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