Comparison of Skin Incision Closure Material for the Tran... | NCT01313754

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

NCT01313754

Sponsor

Loma Linda University

Status

Completed

Last Update Posted

Jan 31, 2013Estimated

Enrollment

160Actual

Phase

Not Applicable

Conditions

Pain, Postoperative
Irritation (Physical)
Pelvic Pain

Interventions

Vicryl Suture
Dermabond

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 10, 2011

First Submission Date that Met QC Criteria

Mar 11, 2011

First Posted Date

Mar 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2013

Last Update Posted Date

Jan 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vicryl Suture	Procedure	Vicryl suture material will be placed on the patients left sided incision.	Vicryl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cosmesis at the incision sites		The patients will be assessed at their 2nd week post operative visit

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sam Siddighi, M.D.		Principal Investigator
David B Waggonner, M.D.		Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University Medical Center		Loma Linda	California	92354	United States

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D017699	Pelvic Pain
D010146	Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011098	Polyglactin 910
C100832	octyl 2-cyanoacrylate

Ancestor Terms

ID	Term
D011091	Polyesters
D011108	Polymers
D046911	Macromolecular Substances
D001697	Biomedical and Dental Materials

Browse Leaves

Not provided

Browse Branches

Not provided