Fingertip AmputationNCT07552753
Semi-occlusive Dressing for Pediatric Fingertip Amputations
An observational study of Fingertip Amputation and Finger Injuries, run by Medical University of Graz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Fingertip Amputation, Finger Injuries
- What is being tested?
- semi-occlusive dressings
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- Child
Study population: 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.
Who may be able to join
- age 0-17 years
- fingertip amputations Allen I-IV
- signed informed consent
Who cannot join
- no signed informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Pediatric Surgery, Medical University of Graz
Graz, 8036
About this study
Official title: 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?
Read the 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.
- Conditions
- Fingertip Amputation, Finger Injuries
- Being tested
- semi-occlusive dressings
- Keywords
- fingertip amputation, children, semi-occlusive dressing, outcome
- Medical subject headings
- Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-occlusive dressingsProcedure or surgery
routine care treatment with semi-occlusive dressings
| Study group | Role | What they receive |
|---|---|---|
| fingertip amputation | children and adolescents with (partial) fingertip amputations (Allen I-IV) treated with semi-occlusive dressings Receives: Procedure: semi-occlusive dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Progression
A pain diary using a visual analogue scale (VAS 0-10); whereas 0 corresponds to no pain and 10 to worst pain
Measured: Assessment once daily until end of treatment with semi-occlusive dressings
Secondary outcomes (4)
Length Loss of the finger
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
Measured: once at follow-up at 6 months post-injury
active range of motion
active range of motion (ROM) of the distal interphalangeal (DIP) joint compared with the corresponding contralateral uninjured finger,measured in ° using a goniometer
Measured: once at follow-up at 6 months post-injury
Percentage of patients with nail growth abnormalities
presence of nail growth abnormalities as assessed by the physician at follow-up
Measured: once at follow-up at 6 months post-injury
Satisfaction with the cosmetic results
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.
Measured: once at follow-up at 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Oct 2022
- Primary completion31 Oct 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fingertip AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Singer, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552753
- Sponsor's protocol ID
- 33-474 ex20/21
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-occlusive Dressing Therapy for Pediatric Fingertip Amputations: a Prospective Observational Study on Pain Progression and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07552753
- Acronym / sponsor ID
- 33-474 ex20/21
- Conditions
- Fingertip Amputation, Finger Injuries
- Keywords
- fingertip amputation, children, semi-occlusive dressing, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fingertip amputation | – | Procedure: semi-occlusive dressingschildren and adolescents with (partial) fingertip amputations (Allen I-IV) treated with semi-occlusive dressings |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- age 0-17 years
- fingertip amputations Allen I-IV
- signed informed consent
Key exclusion criteria (1 listed)
- no signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-occlusive dressingsroutine care treatment with semi-occlusive dressings | Procedure or surgery | fingertip amputation |
Primary outcome
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
4 secondary outcomes
Length Loss of the finger
Time frame: once at follow-up at 6 months post-injury
active range of motion
Time frame: once at follow-up at 6 months post-injury
Percentage of patients with nail growth abnormalities
Time frame: once at follow-up at 6 months post-injury
Satisfaction with the cosmetic results
Time frame: once at follow-up at 6 months post-injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Fingertip Amputation
Recruiting
Non-Contact Low-Frequency Ultrasound Vs Standard LaLonde Protocol for Fingertip Injury Wound Healing
Non-contact Low Frequency Ultrasound, Lalonde Protocol
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Singer, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fingertip Amputation and Finger Injuries, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Progression (time frame: Assessment once daily until end of treatment with semi-occlusive dressings). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.