NCT01017315

Brief Summary

This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients. The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively. Pruritus score and satisfaction will be monitor along the entire course of cast retention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2009

Completed
5 months 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
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

November 17, 2009

Last Update Submit

May 12, 2012

Conditions

Fracture Distal Radius

Keywords

baby talcumprurituscast

Outcome Measures

Primary Outcomes (1)

  • Pruritus score

    2 years

Secondary Outcomes (3)

  • Satisfaction score

    2 years

  • Complication rate

    2 years

  • Number of antihistamine drugs used

    2 years

Study Arms (1)

No application of baby talcum

EXPERIMENTAL

control

Drug: Baby talcum

Interventions

Baby talcumDRUG

50 grams apply locally prior cast application

Also known as: "Care" brand of baby talcum
No application of baby talcum

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fracture distal end radius treated conservatively

You may not qualify if:

  • open fracture
  • skin disease and wound under cast area
  • Fracture distal end radius needed surgical management
  • Allergy to baby talcum

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

Wrist FracturesPruritus

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Boonsin Tangtrakulwanich, MD.,Ph.D

    Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Orthopaedic surgery

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

TH(1)