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Completed

NCT Number: NCT07552753

Semi-occlusive Dressing for Pediatric Fingertip Amputations

The aim of this prospective cohort study is to assess the outcome and pain progression of fingertip (partial) amputations treated with a semi-occlusive wound dressing (regular care) in childhood and adolescence.The main questions it aims to answer are:

* What is the pain progression of children and adolescents with fingertip amputations treated with semi-occlusive wound dressing? * What is the outcome of children and adolescents with fingertip amputations treated with semi-occlusive wound dressing?

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Key information

Conditions

Fingertip Amputation Finger Injuries Hand Injuries Wounds and Injuries

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatric Surgery, Medical University of Graz

Graz, 8036, Austria

About this study

The semi-occlusive wound dressing has now become an established method for treating fingertip (partial) amputations. Very good outcomes have been published for adults. A retrospective study also reports very good results in children (Schultz et al., 2018). However, prospective studies describing the outcomes and pain progression of semi-occlusive wound dressings for fingertip (partial) amputations in children and adolescents are not available.

All children and adolescents treated at our clinic for fingertip (partial) amputations using semi-occlusive wound therapy will be included in the study-following written informed consent from the patients and/or their parents.

A case report form will be completed for each patient. On the day of the accident, data regarding the injury will be recorded and photographic documentation will be performed. Patients or their parents will be given a pain diary to be completed once daily at home. The first follow-up examination will take place after two days, with additional visits scheduled weekly up to and including five weeks after the injury (these visits are part of routine care and would occur regardless of the study).

As part of the study-specific follow-ups at six months, range of motion of the affected distal phalanx (compared side-to-side) will be assessed, and any nail growth disturbances will be documented. Photographs of the affected fingertip and the contralateral side will be taken. Patient satisfaction will be recorded on a scale from 0 (dissatisfied) to 100 (very satisfied).

The routine treatment of these injuries at our clinic will not be altered by the study. The only study-related interventions are the daily completion of a pain diary and clinical follow-up examinations at six months.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 0-17 years
  • fingertip amputations Allen I-IV
  • signed informed consent

Exclusion criteria

  • no signed informed consent

Treatment and study plan

semi-occlusive dressings

Procedure

routine care treatment with semi-occlusive dressings

Primary outcomes

  1. Pain Progression

    Time frame: Assessment once daily until end of treatment with semi-occlusive dressings

    A pain diary using a visual analogue scale (VAS 0-10); whereas 0 corresponds to no pain and 10 to worst pain

Secondary outcomes

  1. Length Loss of the finger

    Time frame: once at follow-up at 6 months post-injury

    Assessment of the length loss of the finger compared to the uninjured side, measured from the distal palmar grease of the DIP joint to the tip of the finger, measured in mm

  2. active range of motion

    Time frame: once at follow-up at 6 months post-injury

    active range of motion (ROM) of the distal interphalangeal (DIP) joint compared with the corresponding contralateral uninjured finger,measured in ° using a goniometer

  3. Percentage of patients with nail growth abnormalities

    Time frame: once at follow-up at 6 months post-injury

    presence of nail growth abnormalities as assessed by the physician at follow-up

  4. Satisfaction with the cosmetic results

    Time frame: once at follow-up at 6 months post-injury

    At final follow-up the patient and/or parent satisfaction (depending on age) are askd to judge their satisfaction with the treatment outcome usng a visual analogue scale (VAS) ranging from 0-100, whereas 0 ist the least satisfaction and 100 corresponds to the best satisfaction.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Semi-occlusive Dressing Therapy for Pediatric Fingertip Amputations: a Prospective Observational Study on Pain Progression and Clinical Outcomes

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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