NCT01017094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

November 17, 2009

Last Update Submit

November 19, 2009

Conditions

Tibial Fracture

Keywords

Pin-site infectionsilversulfadiazineopen fractureopen tibial fracture underwent external fixator

Outcome Measures

Primary Outcomes (1)

  • incidence of pin site infection

    2 years

Secondary Outcomes (2)

  • type of organism

    2 years

  • severity of pin site infection

    2 years

Study Arms (1)

dry dressing

EXPERIMENTAL

local application

Drug: silversulfadiazine

Interventions

silversulfadiazineDRUG

apply once a day

dry dressing

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Immunocompromised patients (diabetes, HIV or malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Tibial FracturesFractures, Open

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Boonsin Tangtrakulwanich, MD.,Ph.D

    Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

September 1, 2007

Primary Completion

June 1, 2008

Study Completion

November 1, 2009

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations

TH(1)