Operative Treatment vs Treatment With Semi-occlusive Dressing for Single Finger Amputations

Sponsor
Tampere University Hospital
Study ID
NCT07175675
Status
Recruiting
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Conditions

  • Amputation
  • Amputation, Traumatic
  • Finger
  • Finger Injuries
  • Finger Injury
  • Fingertips Traumatic Amputations

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Operative treatment of surgeons choice — PROCEDURE
    treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury
  • Semi-occlusive film — PROCEDURE
    The film is placed on a cleansed wound surface. bone is shortened to the level of injury. Visible nerves, arteries and tendons are cut and allowed to retract. The film is to be changed once weekly until the wound has closed.

Study Details

The goal of this interventional study is to find out whether conservative treatment with semi-occlusive film is superior to surgical treatment in single finger amputations in adult population. The main question it aims to answer is: Is PRWHE (Patient Reported Wrist and Hand Evaluation) total score measured at 12 months after injury better in conservatively or operatively treated patients?

Key Dates

First listed
Sep 16, 2025
Start date
Oct 27, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2032
Completion
Jan 31, 2032

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tamai zone 1 operative
    operative treatment of surgeons choice
  • Experimental: Tamai Zone 1 non-operative
    treatment with semi-occlusive film
  • Active Comparator: Tamai zone 2 operative
    Operative treatment of surgeons choice
  • Experimental: Tamai Zone 2 non-operative
    treatment with semi-occlusive film
  • Active Comparator: Tamai Zone 3-4 operative (fingers II-V)
    Operative treatment of surgeons choice
  • Experimental: Tamai Zone 3-4 non-operative (fingers II-V)
    treatment with semi-occlusive film

Primary Outcome Measure

PRWHE [ Time Frame: 12 months ]

Central Contacts

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