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Semi-occlusive Dressing for Pediatric Fingertip Amputations

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07552753
Enrollment
24
Registered
2026-04-27
Start date
2022-10-01
Completion date
2025-04-30
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Finger Injuries, Fingertip Amputation

Keywords

fingertip amputation, children, semi-occlusive dressing, outcome

Brief summary

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?

Detailed description

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.

Interventions

PROCEDUREsemi-occlusive dressings

routine care treatment with semi-occlusive dressings

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years

Inclusion criteria

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

Exclusion criteria

* no signed informed consent

Design outcomes

Primary

MeasureTime frameDescription
Pain ProgressionAssessment once daily until end of treatment with semi-occlusive dressingsA pain diary using a visual analogue scale (VAS 0-10); whereas 0 corresponds to no pain and 10 to worst pain

Secondary

MeasureTime frameDescription
Length Loss of the fingeronce at follow-up at 6 months post-injuryAssessment 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
active range of motiononce at follow-up at 6 months post-injuryactive range of motion (ROM) of the distal interphalangeal (DIP) joint compared with the corresponding contralateral uninjured finger,measured in ° using a goniometer
Percentage of patients with nail growth abnormalitiesonce at follow-up at 6 months post-injurypresence of nail growth abnormalities as assessed by the physician at follow-up
Satisfaction with the cosmetic resultsonce at follow-up at 6 months post-injuryAt 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.

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORGeorg Singer, MD

Medical University of Graz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026