Back to resultsLength of Post Operative Dressing After Carpal Tunnel Release
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
extended postoperative dressing
short postoperative dressing
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring orthopedics, carpal tunnel syndrome, postoperative care
Eligibility Criteria
Inclusion Criteria:
- adults
- carpal tunnel syndrome
Exclusion Criteria:
- previous surgery for Carpal Tunnel Syndrome
- ipsilateral hand, arm, shoulder surgery with continued symptoms
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
extended postoperative dressing
short postoperative dressing
Arm Description
Bulky dressing for 2 weeks
2 day bulky dressing followed by bandaid.
Outcomes
Primary Outcome Measures
Change from baseline in Levine-Katz Scale assessed at different time points.
Symptom and function of Carpal Tunnel Syndrome
Change in the Levine-Katz Scale from baseline(pre-operation) at 2 weeks
Symptom and Function of Carpal Tunnel Syndrome
Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months
Symptom and function of Carpal Tunnel Syndrome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01310218
Brief Title
Length of Post Operative Dressing After Carpal Tunnel Release
Official Title
Length of Postoperative Dressing After Mini-open Carpal Tunnel Release: A Randomized Prospective Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UConn Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
orthopedics, carpal tunnel syndrome, postoperative care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
extended postoperative dressing
Arm Type
Other
Arm Description
Bulky dressing for 2 weeks
Arm Title
short postoperative dressing
Arm Type
Other
Arm Description
2 day bulky dressing followed by bandaid.
Intervention Type
Other
Intervention Name(s)
extended postoperative dressing
Intervention Description
2 weeks of bulky dressing
Intervention Type
Other
Intervention Name(s)
short postoperative dressing
Intervention Description
2 days bulky dressing followed by bandaid
Primary Outcome Measure Information:
Title
Change from baseline in Levine-Katz Scale assessed at different time points.
Description
Symptom and function of Carpal Tunnel Syndrome
Time Frame
Levine-Katz Scale at baseline (pre-operation)
Title
Change in the Levine-Katz Scale from baseline(pre-operation) at 2 weeks
Description
Symptom and Function of Carpal Tunnel Syndrome
Time Frame
Baseline and two weeks.
Title
Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months
Description
Symptom and function of Carpal Tunnel Syndrome
Time Frame
Baseline and three months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults
carpal tunnel syndrome
Exclusion Criteria:
previous surgery for Carpal Tunnel Syndrome
ipsilateral hand, arm, shoulder surgery with continued symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Rodner, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
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Length of Post Operative Dressing After Carpal Tunnel Release
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