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Length of Post Operative Dressing After Carpal Tunnel Release

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310218
First Posted: March 8, 2011
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UConn Health
  Purpose
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.

Condition Intervention Phase
Carpal Tunnel Syndrome Other: extended postoperative dressing Other: short postoperative dressing Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Length of Postoperative Dressing After Mini-open Carpal Tunnel Release: A Randomized Prospective Comparison

Resource links provided by NLM:


Further study details as provided by UConn Health:

Primary Outcome Measures:
  • 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

  • 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

  • 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


Enrollment: 96
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
extended postoperative dressing
Bulky dressing for 2 weeks
Other: extended postoperative dressing
2 weeks of bulky dressing
short postoperative dressing
2 day bulky dressing followed by bandaid.
Other: short postoperative dressing
2 days bulky dressing followed by bandaid

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults
  • carpal tunnel syndrome

Exclusion Criteria:

  • previous surgery for Carpal Tunnel Syndrome
  • ipsilateral hand, arm, shoulder surgery with continued symptoms
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310218


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Investigators
Principal Investigator: Craig Rodner, MD UConn Health
  More Information

Responsible Party: Craig Rodner MD, Unniversity of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01310218     History of Changes
Other Study ID Numbers: UCHC 09-158-1
185190 ( Other Identifier: UCHC )
First Submitted: February 23, 2011
First Posted: March 8, 2011
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by UConn Health:
orthopedics, carpal tunnel syndrome, postoperative care

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries