Pin Site Infection Prevention for Open Tibial Fracture | NCT01017094

Studies
Pin Site Infection Prevention for Open Tibial Fracture

NCT01017094

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

Nov 20, 2009Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Tibial Fracture

Interventions

silversulfadiazine

Countries

Thailand

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

Sep 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Nov 2009Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 19, 2009

First Posted Date

Nov 20, 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

Nov 19, 2009

Last Update Posted Date

Nov 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing.

Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dry dressing	Experimental	local application	Drug: silversulfadiazine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
silversulfadiazine	Drug	apply once a day	dry dressing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of pin site infection		2 years

Secondary Outcomes

Measure	Description	Time Frame
type of organism		2 years
severity of pin site infection		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Open tibial fracture treated with external fixator age between 15-60 years

Exclusion Criteria:

Immunocompromised patients (diabetes, HIV or malignancy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boonsin Tangtrakulwanich, MD.,Ph.D	Faculty of Medicine, Prince of Songkla University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D013978	Tibial Fractures
D005597	Fractures, Open

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

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Browse Branches

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