NCT07175675

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

Operative Treatment vs Treatment With Semi-occlusive Dressing - a Randomized, Controlled Trial on Finger Amputations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

The aim of this study is to compare the outcomes of operative treatment (chosen by the surgeon, including amputation revision with primary skin closure or flap coverage for the tissue defect) versus non-operative treatment using a semi-occlusive dressing for single finger amputations. This study is a randomized controlled superiority trial including three strata, each with two treatment arms, allocated in a 1:1 ratio. The three strata of the study design are based on the level of amputation as follows: Stratum 1 = Tamai Zone 1, Stratum 2 = Tamai Zone 2, Stratum 3 = Tamai Zones 3+4 (fingers II-V only). In all strata, the treatment arms are A (operative) and B (non-operative). Randomization will be performed as computer generated randomization with 1:1 allocation. Primary objective is to determine whether treatment with semi-occlusive dressings is superior to operative treatment after a single finger amputation in each stratum, measured with PRWHE at 12 months after injury.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Operative treatment of surgeons choice	treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury
PROCEDURE	Semi-occlusive film	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.

Timeline

• Start date: 2025-10-27
• Primary completion: 2032-01-01
• Completion: 2032-01-01
• First posted: 2025-09-16
• Last updated: 2025-11-21

Locations

1 site across 1 country: Finland