Carpal Tunnel SyndromePhase 1OCTR-ElectroNCT02791529
Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release
A Phase 1 study testing Electrocautery and Scalpel in people with Carpal Tunnel Syndrome, run by Turku University Hospital.
Trial summary
The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Electrocautery and Scalpel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2018
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 60 years
- Scheduled to undergo open carpal tunnel release (OCTR) by a study group member
- Gives informed consent
- diagnosis of chronic carpal tunnel syndrome
Who cannot join
- -Any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease)
- History of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease)
- Chronic skin condition in the affected upper limb (e.g. psoriasis)
- Pregnancy
- Inability to comprehend the consent form (in Finnish) or inability to give consent
- Previous surgery or scar in the palmar aspect of the affected wrist
- Recurrent carpal tunnel syndrome
- Previous significant trauma of the affected upper extremity (including distal radius fracture) or suspicion of acute onset carpal tunnel syndrome
About this study
Official title: Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release - Randomized, Controlled Open-Label Trial
The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).
Read the detailed description
The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Electrocautery, Scalpel
- 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.
ElectrocauteryProcedure or surgery
Skin incision performed by electrocautery
ScalpelProcedure or surgery
Skin incision performed by scalpel
| Study group | Role | What they receive |
|---|---|---|
| Scalpel | Active comparator | Skin incision performed by scalpel Receives: Procedure: Scalpel |
| Electrocautery | Experimental | Skin incision performed by electrocautery Receives: Procedure: Electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on visual analogue scale
Measured: First postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Intervention was inferior in pilot trial.
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.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791529
- Sponsor's protocol ID
- TYKS/OCTR-Electro/1-2
- Acronym
- OCTR-Electro
- Status last verified
- Mar 2020
- First submitted
- 1 Jun 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release - Randomized, Controlled Open-Label Trial
- ClinicalTrials.gov ID
- NCT02791529
- Acronym / sponsor ID
- OCTR-Electro / TYKS/OCTR-Electro/1-2
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intervention was inferior in pilot trial.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Jun 2016 (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 use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).
Detailed description
The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalpel | Active comparator | Procedure: ScalpelSkin incision performed by scalpel |
| Electrocautery | Experimental | Procedure: ElectrocauterySkin incision performed by electrocautery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 - 60 years
- Scheduled to undergo open carpal tunnel release (OCTR) by a study group member
- Gives informed consent
- diagnosis of chronic carpal tunnel syndrome
Key exclusion criteria (8 listed)
- -Any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease)
- History of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease)
- Chronic skin condition in the affected upper limb (e.g. psoriasis)
- Pregnancy
- Inability to comprehend the consent form (in Finnish) or inability to give consent
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 |
|---|---|---|
| ElectrocauterySkin incision performed by electrocautery | Procedure or surgery | Electrocautery |
| ScalpelSkin incision performed by scalpel | Procedure or surgery | Scalpel |
Primary outcome
Pain on visual analogue scale
Time frame: First postoperative day
Results and safety
The study was stopped early (reason given: Intervention was inferior in pilot trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Electrocautery and Scalpel in people with Carpal Tunnel Syndrome, run by Turku University Hospital.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Intervention was inferior in pilot trial.). Results are not available in the source record.
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?
Pain on visual analogue scale (time frame: First postoperative day). 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 12 Mar 2020.