NCT01310218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

1.4 years

First QC Date

February 23, 2011

Last Update Submit

March 4, 2011

Conditions

Carpal Tunnel Syndrome

Keywords

orthopedics, carpal tunnel syndrome, postoperative care

Outcome Measures

Primary Outcomes (3)

  • 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)

  • Change in the Levine-Katz Scale from baseline(pre-operation) at 2 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

    Symptom and function of Carpal Tunnel Syndrome

    Baseline and three months.

Study Arms (2)

extended postoperative dressing

OTHER

Bulky dressing for 2 weeks

Other: extended postoperative dressing

short postoperative dressing

OTHER

2 day bulky dressing followed by bandaid.

Other: short postoperative dressing

Interventions

extended postoperative dressingOTHER

2 weeks of bulky dressing

extended postoperative dressing
short postoperative dressingOTHER

2 days bulky dressing followed by bandaid

short postoperative dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • carpal tunnel syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Craig Rodner, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2011

First Posted

March 8, 2011

Study Start

May 1, 2009

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

US(1)