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
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?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Graz, Austria, 8036
- Department of Pediatric Surgery, Medical University of Graz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 0-17 years
- fingertip amputations Allen I-IV
- signed informed consent
Exclusion Criteria:
- no signed informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
fingertip amputation
children and adolescents with (partial) fingertip amputations (Allen I-IV) treated with semi-occlusive dressings
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routine care treatment with semi-occlusive dressings
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Progression
Time Frame: Assessment once daily until end of treatment with semi-occlusive dressings
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A pain diary using a visual analogue scale (VAS 0-10); whereas 0 corresponds to no pain and 10 to worst pain
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Assessment once daily until end of treatment with semi-occlusive dressings
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length Loss of the finger
Time Frame: once at follow-up at 6 months post-injury
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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
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once at follow-up at 6 months post-injury
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|
active range of motion
Time Frame: once at follow-up at 6 months post-injury
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active range of motion (ROM) of the distal interphalangeal (DIP) joint compared with the corresponding contralateral uninjured finger,measured in ° using a goniometer
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once at follow-up at 6 months post-injury
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|
Percentage of patients with nail growth abnormalities
Time Frame: once at follow-up at 6 months post-injury
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presence of nail growth abnormalities as assessed by the physician at follow-up
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once at follow-up at 6 months post-injury
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Satisfaction with the cosmetic results
Time Frame: once at follow-up at 6 months post-injury
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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.
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once at follow-up at 6 months post-injury
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Georg Singer, MD, Medical University of Graz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33-474 ex20/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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