Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast

Fracture Distal Radius Clinical Trial

Official title:

Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01017315
• Other study ID #: 52-197-11-4-2
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: November 17, 2009
• Last updated: May 12, 2012
• Start date: July 2009
• Est. completion date: October 2012

Study information

• Verified date: May 2012
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Fracture distal end radius treated conservatively

Exclusion Criteria:

• open fracture

• skin disease and wound under cast area

• Fracture distal end radius needed surgical management

• Allergy to baby talcum

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fracture Distal Radius
• Pruritus

Intervention

Drug:
• Baby talcum
50 grams apply locally prior cast application

Locations

Country	Name	City	State
Thailand	Prince of Songkla university	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus score		2 years	No
Secondary	Satisfaction score		2 years	No
Secondary	Complication rate		2 years	No
Secondary	Number of antihistamine drugs used		2 years	No