Surgery or semi-occlusive dressing for a single finger amputation
Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations
NA · Tampere University Hospital · NCT07175675
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital (other) |
| Locations | 1 site (Tampere) |
| Trial ID | NCT07175675 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Smaller case series and non-randomized reports have shown good healing and function with semi-occlusive dressings, but high-quality randomized comparisons are limited.
Eligibility criteria
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 this trial is running
Tampere
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fingertips Traumatic Amputations, Finger Injuries, Finger, Finger Injury, Amputation, Traumatic, Amputation, finger amputation, single finger amputation