Length of Post Operative Dressing After Carpal Tunnel Release

March 4, 2011 updated by: UConn Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults
  • carpal tunnel syndrome

Exclusion Criteria:

  • previous surgery for Carpal Tunnel Syndrome
  • ipsilateral hand, arm, shoulder surgery with continued symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: extended postoperative dressing
Bulky dressing for 2 weeks
Other: extended postoperative dressing
2 weeks of bulky dressing
Other: short postoperative dressing
2 day bulky dressing followed by bandaid.
Other: short postoperative dressing
2 days bulky dressing followed by bandaid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Levine-Katz Scale assessed at different time points.
Time Frame: Levine-Katz Scale at baseline (pre-operation)
Symptom and function of Carpal Tunnel Syndrome
Levine-Katz Scale at baseline (pre-operation)
Change in the Levine-Katz Scale from baseline(pre-operation) at 2 weeks
Time Frame: Baseline and two weeks.
Symptom and Function of Carpal Tunnel Syndrome
Baseline and two weeks.
Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months
Time Frame: Baseline and three months.
Symptom and function of Carpal Tunnel Syndrome
Baseline and three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Investigators

  • Principal Investigator: Craig Rodner, MD, UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 23, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 4, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCHC 09-158-1
  • 185190 (Other Identifier: UCHC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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