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NCT01310218 Clinical Trial

Length of Post Operative Dressing After Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:
Length of Postoperative Dressing After Mini-open Carpal Tunnel Release: A Randomized Prospective Comparison

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01310218
Other study ID # UCHC 09-158-1
Secondary ID 185190
Status Completed
Phase Phase 4
First received February 23, 2011
Last updated March 4, 2011
Start date May 2009
Est. completion date November 2010

Study information
Verified date March 2011
Source University of Connecticut Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study is to prospectively compare the functional, satisfaction, and wound outcomes of patients treated with one of two accepted methods of postoperative dressing following carpal tunnel release. Hypothesis: There will be no difference between the short term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms of outcomes.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date November 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults

- carpal tunnel syndrome

Exclusion Criteria:

- previous surgery for Carpal Tunnel Syndrome

- ipsilateral hand, arm, shoulder surgery with continued symptoms

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• extended postoperative dressing
2 weeks of bulky dressing
• short postoperative dressing
2 days bulky dressing followed by bandaid

Locations
Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (1)
Lead Sponsor Collaborator
University of Connecticut Health Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Levine-Katz Scale assessed at different time points. Symptom and function of Carpal Tunnel Syndrome Levine-Katz Scale at baseline (pre-operation) No
Primary Change in the Levine-Katz Scale from baseline(pre-operation) at 2 weeks Symptom and Function of Carpal Tunnel Syndrome Baseline and two weeks. No
Primary Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months Symptom and function of Carpal Tunnel Syndrome Baseline and three months. No
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