Text Size

Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017315
First received: November 17, 2009
Last updated: May 12, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fracture Distal Radius
 Drug: Baby talcum
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Fractures Itching
U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Pruritus score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Complication rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of antihistamine drugs used [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No application of baby talcum
control
 Drug: Baby talcum
50 grams apply locally prior cast application
Other Name: "Care" brand of baby talcum

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017315

Locations
Thailand
Prince of Songkla university
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D Prince of Songkla University
  More Information

No publications provided

Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017315     History of Changes
Other Study ID Numbers: 52-197-11-4-2
Study First Received: November 17, 2009
Last Updated: May 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
baby talcum
pruritus
cast

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013