Carpal Tunnel SyndromeNCT03781141
Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery
A study testing Wound closure in people with Carpal Tunnel Syndrome and Trigger Finger, run by Mayo Clinic at 1 site in United States.
Trial summary
Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Trigger Finger
- What is being tested?
- Wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 Mar 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient greater than or equal to 18 years of age.
- Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release
Who cannot join
- Any patient identified outside of the proposed study time period.
- Any patient receiving revision surgery
- Patients who have had prior ipsilateral palmar or finger surgery
- Patients with Dupuytren's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure
Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.
Read the detailed description
The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger
- Being tested
- Wound closure
- Medical subject headings
- Carpal Tunnel Syndrome, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound closureProcedure or surgery
Comparison of two wound closures
| Study group | Role | What they receive |
|---|---|---|
| Absorbable suture | Experimental | Wound closure with absorbable suture. Receives: Procedure: Wound closure |
| Non-absorbable suture | Active comparator | Wound closure with non-absorbable suture. Receives: Procedure: Wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar formation with the Patient and Observer Scare Assessment Scale
Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS).
The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Dec 2019
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Why it stopped: change in practice pattern
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 Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter C. Rhee, Mayo Clinic
- Investigators
- Peter C Rhee, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781141
- Sponsor's protocol ID
- 18-004267
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2018
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure
- ClinicalTrials.gov ID
- NCT03781141
- Acronym / sponsor ID
- 18-004267
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change in practice pattern
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 19 Dec 2018 (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.
Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.
Detailed description
The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable suture | Experimental | Procedure: Wound closureWound closure with absorbable suture. |
| Non-absorbable suture | Active comparator | Procedure: Wound closureWound closure with non-absorbable suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient greater than or equal to 18 years of age.
- Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release
Key exclusion criteria (4 listed)
- Any patient identified outside of the proposed study time period.
- Any patient receiving revision surgery
- Patients who have had prior ipsilateral palmar or finger surgery
- Patients with Dupuytren's disease
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 |
|---|---|---|
| Wound closureComparison of two wound closures | Procedure or surgery | Absorbable suture, Non-absorbable suture |
Primary outcome
Scar formation with the Patient and Observer Scare Assessment Scale
Time frame: 1 year
Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS). The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Peter C Rhee principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound closure in people with Carpal Tunnel Syndrome and Trigger Finger, run by Mayo Clinic 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 4 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: withdrawn, as of the sponsor's last update on 5 Mar 2026. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Scar formation with the Patient and Observer Scare Assessment Scale (time frame: 1 year). 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 5 Mar 2026.