Surgery or semi-occlusive dressing for a single finger amputation
Official title: Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations
Run by Tampere University Hospital · NCT07175675 · Data updated 2026-11-12
This study will test whether a semi-occlusive film dressing or surgery gives better hand function for adults who have lost the tip of a single finger.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 252 (estimated) |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 1 site (Tampere) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | January 2032 |
| Study ends | January 2032 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07175675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with a single-digit amputation at the specified Tamai zones (zones 1 or 2 for any digit, or zones 3–4 for fingers II–V) who can understand Finnish and complete self-reported questionnaires are ideal candidates.
✕Probably not a fit
Patients with prior partial or total amputation of the injured digit, preexisting conditions that substantially affect hand function, pregnant patients, or those with multiple digit injuries are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, controlled superiority trial comparing operative treatment (surgeon’s choice of revision/amputation with primary closure or flap coverage) to non-operative treatment with a semi-occlusive film dressing for single finger amputations. Patients are randomized 1:1 within three strata defined by Tamai amputation level (zone 1; zone 2; zones 3+4 for fingers II–V). The primary outcome is the PRWHE total score measured 12 months after injury, and follow-up includes patient-reported outcomes and clinical assessments. The trial is conducted at Tampere University Hospital and includes adults who can complete Finnish-language questionnaires.
Why it matters
Potential benefit: If successful, the non-operative semi-occlusive approach could allow many patients to avoid surgery while achieving equal or better hand function.
How similar studies have gone: Smaller case series and non-randomized reports have shown good healing and function with semi-occlusive dressings, but high-quality randomized comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>18, single digit injury, Amputation at Tamai zones 1+2 in all digits or Tamai zones 3+4 in digits II-V, Able to understand Finnish and to complete self-reported questionnaires Exclusion Criteria: * Previous partial or total amputation of the injured digit, Previous condition which affects significantly the function and/or symptoms of the affected hand, Patient is pregnant at the time of recruitment
Where it's running
-
Tampere Univesity Hospital
Tampere, Finland Recruiting
Study contacts
- Principal investigator: Jarkko Jokihaara, Professor — Tampere University Hospital
- Study coordinator: Reetta M Kvist, Licentiate
- Email: reetta.kvist@pirha.fi
- Phone: +358 03311611
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.