Back to resultsEfficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast
Primary Purpose
Fracture Distal Radius
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Baby talcum
Sponsored by
About this trial
This is an interventional prevention trial for Fracture Distal Radius focused on measuring baby talcum, pruritus, cast
Eligibility Criteria
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
Sites / Locations
- Prince of Songkla university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
No application of baby talcum
Arm Description
control
Outcomes
Primary Outcome Measures
Pruritus score
Secondary Outcome Measures
Satisfaction score
Complication rate
Number of antihistamine drugs used
Full Information
NCT ID
NCT01017315
First Posted
November 17, 2009
Last Updated
May 12, 2012
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01017315
Brief Title
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast
Official Title
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Distal Radius
Keywords
baby talcum, pruritus, cast
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No application of baby talcum
Arm Type
Experimental
Arm Description
control
Intervention Type
Drug
Intervention Name(s)
Baby talcum
Other Intervention Name(s)
"Care" brand of baby talcum
Intervention Description
50 grams apply locally prior cast application
Primary Outcome Measure Information:
Title
Pruritus score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Satisfaction score
Time Frame
2 years
Title
Complication rate
Time Frame
2 years
Title
Number of antihistamine drugs used
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonsin Tangtrakulwanich, MD.,Ph.D
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla university
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast
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