Length of Post Operative Dressing After Carpal Tunnel Release

This study has been completed.
Sponsor:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01310218
First received: February 23, 2011
Last updated: March 4, 2011
Last verified: March 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Connecticut Health Center:

Primary Outcome Measures:
  • Change from baseline in Levine-Katz Scale assessed at different time points. [ Time Frame: Levine-Katz Scale at baseline (pre-operation) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310218

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

No publications provided

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
Study First Received: February 23, 2011
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
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

ClinicalTrials.gov processed this record on April 21, 2014