The Impact of Using Triclosan-antibacterial Sutures on th... | NCT01019447

Studies
The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection

NCT01019447

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jun 22, 2011Estimated

Enrollment

701Actual

Phase

Phase 4

Conditions

Surgical Site Infection

Interventions

Vicryl Plus
Vicryl

Countries

Egypt

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

Nov 2009

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

Nov 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Nov 23, 2009

First Submission Date that Met QC Criteria

Nov 23, 2009

First Posted Date

Nov 25, 2009Estimated

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

Jun 21, 2011

Last Update Posted Date

Jun 22, 2011Estimated

Name	Class
Amygate Healthcare	UNKNOWN

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

To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

701Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Active Comparator	The study group in which Triclosan-coated polyglactin 910 antimicrobial sutures will be used.	Other: Vicryl Plus
Control group	Active Comparator	The control group in which polyglactin 910 antimicrobial sutures will be used.	Other: Vicryl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vicryl Plus	Other	Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria		30 days (or 1 year in case of prosthesis)

Secondary Outcomes

Measure	Description	Time Frame
Post-operative hospital stay in days		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients of different age
Gender
Risk factors and procedures candidate for surgical intervention during the period of the study

Exclusion Criteria:

Patients with an established pre-operative infection at the operative site

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ibrahim Ga Ibrahim, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Zeraaein Hospital		Cairo	Cairo Governorate		Egypt
Cairo University Kasr Al-Aini Hospital

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011098	Polyglactin 910

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided