Trigger Finger DisorderNCT04268095
Post Operative Dressing After Clean Elective Hand Surgery
A study testing Dressing protocol in people with Trigger Finger Disorder and Carpal Tunnel Syndrome, run by Itay Ashkenazi at 1 site in Israel.
Trial summary
Very little has been published about the optimal post operative dressing protocol, and no practical conclusion has emerged from a meta-analysis published in 2013. Even fewer studies focused on that topic specifically in hand surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger Disorder, Carpal Tunnel Syndrome, Ganglion
- What is being tested?
- Dressing protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2019to 1 Feb 2021
- Phase
- Interventional
- 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
- Elective hand surgery with clean wound (Type 1 in wound classification of american college of surgeon 11) - (Carpal tunnel, trigger finger, cyst removal or foreign body removal, tendon release).
Who cannot join
- Insertion of hardware
- Known skin condition disturbing normal healing,
- Immunodeficiency,
- Incapacity to understand or to observe the self cleaning protocol.
- Unexpected peroperative complication leading to a modification of the operative technique.
Trial locations and contacts
1 site in 1 country.
About this study
Very little has been published about the optimal post operative dressing protocol, and no practical conclusion has emerged from a meta-analysis published in 2013. Even fewer studies focused on that topic specifically in hand surgery. Nevertheless, the functional impairment due to a dressing in the hand is much greater than anywhere else, due to the constant use of hands in daily life activities. Yet, habits differs widely following surgeon's preference, from daily change with application of an antimicrobial unguent, to unchanged dressing until the first follow up consultation after 2 weeks, to complete removal of the dressing and basic soap and water cleaning at postoperative day (POD) 1. Those varying recommendations have functional and logistical implication for the patients, especially the elderlies, for whom autonomy is a fragile status that can be dramatically impaired by such protocols. The goal of this study is to define which post operative dressing protocol is optimal in terms of wound complications (disunion, infection)
- Conditions
- Trigger Finger Disorder, Carpal Tunnel Syndrome, Ganglion
- Being tested
- Dressing protocol
- Medical subject headings
- Trigger Finger Disorder, Carpal Tunnel Syndrome, Ganglion Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dressing protocolOther
Patients are assigned with different postoperative dressing protocols.
| Study group | Role | What they receive |
|---|---|---|
| No dressing change | Experimental | Patients do not change dressing from procedure to first clinic followup after 14 days. Receives: Other: Dressing protocol |
| Ambulatory dressing change | Experimental | Patients change dressing by an ambulatory nurse (not associated with the study) 2 times a week from surgery to first clinic followup after 14 days Receives: Other: Dressing protocol |
| No dressing | Experimental | Patients take off dressing at post operative day 1 and clean it 3 times per day as instructed. Receives: Other: Dressing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Instrumental activities of daily living questioner (IADL)
Subjective function questioner. Scale 0-18. Higher score - better outcome.
Measured: Baseline (Pre-op), 2 weeks, 6 weeks, 3 months
Change in Vancouver Scar Scale
Evaluation of skin healing and scar formation. Scale 0-14. Higher score - inferior outcome.
Measured: 2 weeks, 6 weeks, 3 months
Change in quick Disability of the Arm, Shoulder and Hand questioner (DASH)
Subjective function questioner. Scale 0-100. Higher score - inferior outcome.
Measured: Baseline, 2 weeks, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start31 Dec 2019
- Primary completion31 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Finger DisorderStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Itay Ashkenazi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Itay Ashkenazi, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268095
- Sponsor's protocol ID
- 0548-18-TLV
- Status last verified
- Apr 2021
- First submitted
- 5 Feb 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared at the discretion of the Chief Investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Dressing After Clean Elective Hand Surgery
- ClinicalTrials.gov ID
- NCT04268095
- Acronym / sponsor ID
- 0548-18-TLV
- Conditions
- Trigger Finger Disorder, Carpal Tunnel Syndrome, Ganglion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Itay AshkenaziUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 13 Feb 2020 (actual)
- 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.
Very little has been published about the optimal post operative dressing protocol, and no practical conclusion has emerged from a meta-analysis published in 2013. Even fewer studies focused on that topic specifically in hand surgery. Nevertheless, the functional impairment due to a dressing in the hand is much greater than anywhere else, due to the constant use of hands in daily life activities. Yet, habits differs widely following surgeon's preference, from daily change with application of an antimicrobial unguent, to unchanged dressing until the first follow up consultation after 2 weeks, to complete removal of the dressing and basic soap and water cleaning at postoperative day (POD) 1. Those varying recommendations have functional and logistical implication for the patients, especially the elderlies, for whom autonomy is a fragile status that can be dramatically impaired by such protocols. The goal of this study is to define which post operative dressing protocol is optimal in terms of wound complications (disunion, infection)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No dressing change | Experimental | Other: Dressing protocolPatients do not change dressing from procedure to first clinic followup after 14 days. |
| Ambulatory dressing change | Experimental | Other: Dressing protocolPatients change dressing by an ambulatory nurse (not associated with the study) 2 times a week from surgery to first clinic followup after 14 days |
| No dressing | Experimental | Other: Dressing protocolPatients take off dressing at post operative day 1 and clean it 3 times per day as instructed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective hand surgery with clean wound (Type 1 in wound classification of american college of surgeon 11) - (Carpal tunnel, trigger finger, cyst removal or foreign body removal, tendon release).
Key exclusion criteria (5 listed)
- Insertion of hardware
- Known skin condition disturbing normal healing,
- Immunodeficiency,
- Incapacity to understand or to observe the self cleaning protocol.
- Unexpected peroperative complication leading to a modification of the operative technique.
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 |
|---|---|---|
| Dressing protocolPatients are assigned with different postoperative dressing protocols. | Other | Ambulatory dressing change, No dressing, No dressing change |
Primary outcome
Change in Instrumental activities of daily living questioner (IADL)
Time frame: Baseline (Pre-op), 2 weeks, 6 weeks, 3 months
Subjective function questioner. Scale 0-18. Higher score - better outcome.
Change in Vancouver Scar Scale
Time frame: 2 weeks, 6 weeks, 3 months
Evaluation of skin healing and scar formation. Scale 0-14. Higher score - inferior outcome.
Change in quick Disability of the Arm, Shoulder and Hand questioner (DASH)
Time frame: Baseline, 2 weeks, 6 weeks, 3 months
Subjective function questioner. Scale 0-100. Higher score - inferior outcome.
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 6 Apr 2021.
- Individual participant dataSharing planned: Yes. Data will be shared at the discretion of the Chief Investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing protocol in people with Trigger Finger Disorder and Carpal Tunnel Syndrome, run by Itay Ashkenazi at 1 site in Israel.
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 1 inclusion and 5 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 6 Apr 2021. 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 Israel. 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.
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 in Instrumental activities of daily living questioner (IADL) (time frame: Baseline (Pre-op), 2 weeks, 6 weeks, 3 months). 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 6 Apr 2021.