Carpal Tunnel SyndromePhase 4NCT01310218
Length of Post Operative Dressing After Carpal Tunnel Release
A Phase 4 study testing extended postoperative dressing and short postoperative dressing in people with Carpal Tunnel Syndrome, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- extended postoperative dressing and short postoperative dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- carpal tunnel syndrome
Who cannot join
- previous surgery for Carpal Tunnel Syndrome
- ipsilateral hand, arm, shoulder surgery with continued symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- extended postoperative dressing, short postoperative dressing
- Keywords
- orthopedics, carpal tunnel syndrome, postoperative care
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended postoperative dressingOther
2 weeks of bulky dressing
short postoperative dressingOther
2 days bulky dressing followed by bandaid
| Study group | Role | What they receive |
|---|---|---|
| extended postoperative dressing | Other | Bulky dressing for 2 weeks Receives: Other: extended postoperative dressing |
| short postoperative dressing | Other | 2 day bulky dressing followed by bandaid. Receives: Other: short postoperative dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Levine-Katz Scale assessed at different time points.
Symptom and function of Carpal Tunnel Syndrome
Measured: 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
Measured: Baseline and two weeks.
Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months
Symptom and function of Carpal Tunnel Syndrome
Measured: Baseline and three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Investigators
- Craig Rodner, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310218
- Sponsor's protocol ID
- UCHC 09-158-1
- Other IDs
- 185190
- Status last verified
- Mar 2011
- First submitted
- 23 Feb 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Length of Postoperative Dressing After Mini-open Carpal Tunnel Release: A Randomized Prospective Comparison
- ClinicalTrials.gov ID
- NCT01310218
- Acronym / sponsor ID
- UCHC 09-158-1
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- orthopedics, carpal tunnel syndrome, postoperative care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended postoperative dressing | Other | Other: extended postoperative dressingBulky dressing for 2 weeks |
| short postoperative dressing | Other | Other: short postoperative dressing2 day bulky dressing followed by bandaid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults
- carpal tunnel syndrome
Key exclusion criteria (2 listed)
- previous surgery for Carpal Tunnel Syndrome
- ipsilateral hand, arm, shoulder surgery with continued symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended postoperative dressing2 weeks of bulky dressing | Other | extended postoperative dressing |
| short postoperative dressing2 days bulky dressing followed by bandaid | Other | short postoperative dressing |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Rodner, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing extended postoperative dressing and short postoperative dressing in people with Carpal Tunnel Syndrome, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Levine-Katz Scale assessed at different time points. (time frame: Levine-Katz Scale at baseline (pre-operation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.