MedDataX Logo

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

NCT ID: NCT01313754

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Irritation (Physical) Pelvic Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Vicryl Suture

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

Dermabond

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vicryl Suture

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

Intervention Type PROCEDURE

Dermabond

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

polyglactin 910 2-octyl cyanoacrylate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Non-English speaking.
* Allergy to monocryl, vicryl, or dermabond.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Waggonner, MD

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sam Siddighi, M.D.

Role: PRINCIPAL_INVESTIGATOR

David B Waggonner, M.D.

Role: STUDY_DIRECTOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DWSS-01

Identifier Type: -

Identifier Source: org_study_id