Finger InjuriesNCT03089060
Silicone Finger Cap ("Silikonfingerling")
A study testing Silicone Finger cap and Film Dressing in people with Finger Injuries, run by Orthopädie- und Rehatechnik Dresden GmbH at 1 site in Germany.
Trial summary
Amputation injuries of the fingertip are common in all ages. For decades it is known that conservatively treated fingertips can regenerate skin and soft tissues to form a functionally and cosmetically excellent new fingertip. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Finger Injuries
- What is being tested?
- Silicone Finger cap and Film Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 21 Sep 2017to 3 Feb 2020
- Phase
- Interventional
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- full skin substances defects distal to the distal interphalangeal joint (DIP-joint) unsuitable for primary surgical closure without further substance loss
- no more than five fingers per patient may be injured
- circumference of the proximal phalanx in between 3.0 cm and 9.0 cm
- signed informed consent
Who cannot join
- known hypersensitivity against medical silicone or self-adhesive films
- bony injuries requiring a surgical intervention
- bite injuries
- chronic dermatologic disorders of the hand
- intake of medications affecting wound healing, for instance/such as systemic (non-inhalative) glucocorticoids, immunosuppressive or blood-thinning medications
- known wound healing disorders
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- ongoing or recently finished chemotherapy
- primary/congenital immunodeficiency
- diabetes mellitus
- pregnant or breastfeeding patients/women, as well as any women, when a pregnancy at the beginning or during the course of the study cannot be excluded (i.e. post-menopausal, oophorectomy or hysterectomy, contraceptive method with pearl index less than 1 %, sexual abstinence or partner with vasectomy)
- addiction or other diseases, which do not allow to assess the entity, scope and possible consequences of this clinical trial
- not cooperative patients
- participation in a clinical trial within the last four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on the Semi-occlusive Treatment of Traumatic Substance Defects of the Fingertip in Children and Adults With a Novel Silicone Finger Cap. ("Klinische Prüfung Zur Semiokklusiven Behandlung Von Traumatischen Substanzdefekten im Bereich Der Fingerendglieder Mittels Silikonfingerorthesen (Silikonfingelingen) Bei Kindern Und Erwachsenen")
Amputation injuries of the fingertip are common in all ages. For decades it is known that conservatively treated fingertips can regenerate skin and soft tissues to form a functionally and cosmetically excellent new fingertip. Unfortunately, little is known about the mechanisms controlling this ability that, in humans, is confined to the fingertips. Even less is known about the bacteria that regularly colonize these wounds without noticeable negative impact on regeneration and healing. Medical evidence on fingertip regeneration in humans is largely limited to retrospective studies and case reports. This study will be the first randomized controlled trial on the conservative treatment of fingertip amputations in children and adults.
When managed without surgery, self-adhesive polyurethane film dressings are commonly used to establish a wet chamber around the injury. This provides the best conditions for tissue regeneration inhibiting the formation of scar tissue at the same time. Unfortunately these dressings do not offer mechanical protection, they do not stick to wet skin and leak malodorous wound fluid. The investigators therefore developed a silicone finger cap that deals with these problems offering a mechanically protected, wet chamber around the injury for optimal regeneration conditions. This finger cap also offers a puncturable reservoir for excess wound fluid, which by this route can be routinely analyzed for diagnostic and research purposes.
Read more
This randomized controlled trial will for the first time test acceptance, safety and efficacy of this novel medical device in comparison with conventional self-adhesive film dressings while gathering information on the clinical course and outcome of conservatively treated fingertip amputation injuries.
Based on sample size calculations for primary outcome, 22 patients older than 2 years will be enrolled within 24 hours after having suffered an injury distal to the distal interphalangeal joint comprising all layers of the skin with a substance defect that cannot be primarily adapted without further shortening of the finger or plastic surgery. Participants are randomly assigned to start their treatment for the first two weeks either with a conventional film dressing or with the novel silicone finger cap. They will be changed to the other modality for another two weeks before the patient or the guardian can decide, if they would want the film dressing or the finger cap for the rest of the treatment.
- Conditions
- Finger Injuries
- Being tested
- Silicone Finger cap, Film Dressing
- Keywords
- Fingertip Amputation, Fingertip Regeneration, Infection, Occlusive Dressings, Pediatric Surgery, Silicone Finger Cap
- Medical subject headings
- Finger Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Finger capDevice
Treatment with silicone finger cap
Film DressingDevice
Treatment with conventional film dressing
| Study group | Role | What they receive |
|---|---|---|
| Silicone Finger Cap | Experimental | Patients randomized to this arm will be treated with the novel silicone finger cap for the first two weeks of treatment. Receives: Device: Silicone Finger cap; Device: Film Dressing |
| Film dressing | Active comparator | Patients randomized to this arm will be treated with conventional film dressings for the first two weeks of treatment. Receives: Device: Silicone Finger cap; Device: Film Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance
Acceptance of the silicone finger cap in comparison with conventional film dressings. Patient decides which dressing he or she prefers for the remaining treatment.
Measured: At day 28 after injury
Secondary outcomes (9)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety of the finger cap in comparison to the film dressing. Patients are asked for adverse events (AE) or serious adverse events (SAE).
Measured: At Day 0, 1, 7, 14, 21, 28, 35, 42 resp. till wound healing is complete.
Disease-specific quality of life
Determination of disease-specific quality of life during the treatment with the silicon finger cap in comparison to the film dressing using a modified quality of life Wuerzburg Wound Score
Measured: At Day 0, 1, 7, 14, 21, 28, 35, 42 and 4 months resp. till wound healing is complete.
Unplanned dressing changes as measured by number of dressing changes in addition to number of visits according to study protocol.
Necessity of unplanned dressing changes in comparison to the film dressing.
Measured: Up to 42 days resp. till wound healing is complete.
Microbiological colonization
Changes in microbiological colonization in the wound during treatment using microbiological analysis.
Measured: At Day 0, 1, 7, 14, 21, 28, 35, 42 resp. till wound healing is complete (if wound fluid is aspirable).
Re-epithelialization rate
Measuring of re-epithelialization rate
Measured: At Day 14, 28, 42 resp. till wound healing is complete.
Tissue growth
Determination of tissue growth during treatment using medical ultrasound
Measured: At day 28 and 4 months.
Function of the regenerated perspiratory glands
Ceck of function of the regenerated perspiratory glands using Moberg's Ninhydrin test.
Measured: At 4 months (Day 122).
Sensibility/Sensitivity of the injured fingertip
Check of sensibility/sensitivity of the injured fingertip using 2-point-discrimination threshold in the area of the injury is checked in comparison to the corresponding finger of the contralateral hand
Measured: At 4 months (Day 122).
Cosmetic aspects, measured using a check list/questionnaire
Checking a list of common deformities i.e. scarring, split nails.
Measured: At 4 months (Day 122).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start21 Sep 2017
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Finger InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- monocentric, prospective, randomized, controlled, pseudo-cross-over
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopädie- und Rehatechnik Dresden GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden
- Responsible party
- Sponsor
- Investigators
- Guido Fitze, Prof. Dr., Study director, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089060
- Sponsor's protocol ID
- ORD0001/2014
- Status last verified
- Feb 2020
- First submitted
- 7 Mar 2017
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schultz J, Patel PA, Aires R, Wissing L, Glatte P, Seifert M, Gentzel M, Fitze G, Doyle AM, Sandoval-Guzman T. Human fingertip regeneration follows clinical phases with distinct proteomic signatures. NPJ Regen Med. 2025 Nov 5;10(1):51. doi: 10.1038/s41536-025-00441-y.
PubMed 41193504Schultz J, Leupold S, Grahlert X, Pfeiffer R, Schwanebeck U, Schrottner P, Djawid B, Artsimovich W, Kozak K, Fitze G. Study protocol for a randomized controlled pilot-trial on the semiocclusive treatment of fingertip amputation injuries using a novel finger cap. Medicine (Baltimore). 2017 Oct;96(41):e8224. doi: 10.1097/MD.0000000000008224.
PubMed 29019891
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Semi-occlusive Treatment of Traumatic Substance Defects of the Fingertip in Children and Adults With a Novel Silicone Finger Cap. ("Klinische Prüfung Zur Semiokklusiven Behandlung Von Traumatischen Substanzdefekten im Bereich Der Fingerendglieder Mittels Silikonfingerorthesen (Silikonfingelingen) Bei Kindern Und Erwachsenen")
- ClinicalTrials.gov ID
- NCT03089060
- Acronym / sponsor ID
- ORD0001/2014
- Conditions
- Finger Injuries
- Keywords
- Fingertip Amputation, Fingertip Regeneration, Infection, Occlusive Dressings, Pediatric Surgery, Silicone Finger Cap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Orthopädie- und Rehatechnik Dresden GmbHUniversity, hospital or other
- Collaborators
- Technische Universität Dresden
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 24 Mar 2017 (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.
Amputation injuries of the fingertip are common in all ages. For decades it is known that conservatively treated fingertips can regenerate skin and soft tissues to form a functionally and cosmetically excellent new fingertip. Unfortunately, little is known about the mechanisms controlling this ability that, in humans, is confined to the fingertips. Even less is known about the bacteria that regularly colonize these wounds without noticeable negative impact on regeneration and healing. Medical evidence on fingertip regeneration in humans is largely limited to retrospective studies and case reports. This study will be the first randomized controlled trial on the conservative treatment of fingertip amputations in children and adults.
When managed without surgery, self-adhesive polyurethane film dressings are commonly used to establish a wet chamber around the injury. This provides the best conditions for tissue regeneration inhibiting the formation of scar tissue at the same time. Unfortunately these dressings do not offer mechanical protection, they do not stick to wet skin and leak malodorous wound fluid. The investigators therefore developed a silicone finger cap that deals with these problems offering a mechanically protected, wet chamber around the injury for optimal regeneration conditions. This finger cap also offers a puncturable reservoir for excess wound fluid, which by this route can be routinely analyzed for diagnostic and research purposes.
This randomized controlled trial will for the first time test acceptance, safety and efficacy of this novel medical device in comparison with conventional self-adhesive film dressings while gathering information on the clinical course and outcome of conservatively treated fingertip amputation injuries.
Based on sample size calculations for primary outcome, 22 patients older than 2 years will be enrolled within 24 hours after having suffered an injury distal to the distal interphalangeal joint comprising all layers of the skin with a substance defect that cannot be primarily adapted without further shortening of the finger or plastic surgery. Participants are randomly assigned to start their treatment for the first two weeks either with a conventional film dressing or with the novel silicone finger cap. They will be changed to the other modality for another two weeks before the patient or the guardian can decide, if they would want the film dressing or the finger cap for the rest of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric, prospective, randomized, controlled, pseudo-cross-over
| Arm | Type | Receives |
|---|---|---|
| Silicone Finger Cap | Experimental | Device: Silicone Finger cap, Device: Film DressingPatients randomized to this arm will be treated with the novel silicone finger cap for the first two weeks of treatment. |
| Film dressing | Active comparator | Device: Silicone Finger cap, Device: Film DressingPatients randomized to this arm will be treated with conventional film dressings for the first two weeks of treatment. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- full skin substances defects distal to the distal interphalangeal joint (DIP-joint) unsuitable for primary surgical closure without further substance loss
- no more than five fingers per patient may be injured
- circumference of the proximal phalanx in between 3.0 cm and 9.0 cm
- signed informed consent
Key exclusion criteria (13 listed)
- known hypersensitivity against medical silicone or self-adhesive films
- bony injuries requiring a surgical intervention
- bite injuries
- chronic dermatologic disorders of the hand
- intake of medications affecting wound healing, for instance/such as systemic (non-inhalative) glucocorticoids, immunosuppressive or blood-thinning medications
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 |
|---|---|---|
| Silicone Finger capTreatment with silicone finger cap | Device | Film dressing, Silicone Finger Cap |
| Film DressingTreatment with conventional film dressing | Device | Film dressing, Silicone Finger Cap |
Primary outcome
Acceptance
Time frame: At day 28 after injury
Acceptance of the silicone finger cap in comparison with conventional film dressings. Patient decides which dressing he or she prefers for the remaining treatment.
9 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: At Day 0, 1, 7, 14, 21, 28, 35, 42 resp. till wound healing is complete.
Disease-specific quality of life
Time frame: At Day 0, 1, 7, 14, 21, 28, 35, 42 and 4 months resp. till wound healing is complete.
Unplanned dressing changes as measured by number of dressing changes in addition to number of visits according to study protocol.
Time frame: Up to 42 days resp. till wound healing is complete.
Microbiological colonization
Time frame: At Day 0, 1, 7, 14, 21, 28, 35, 42 resp. till wound healing is complete (if wound fluid is aspirable).
Re-epithelialization rate
Time frame: At Day 14, 28, 42 resp. till wound healing is complete.
Tissue growth
Time frame: At day 28 and 4 months.
Function of the regenerated perspiratory glands
Time frame: At 4 months (Day 122).
Sensibility/Sensitivity of the injured fingertip
Time frame: At 4 months (Day 122).
Cosmetic aspects, measured using a check list/questionnaire
Time frame: At 4 months (Day 122).
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 2 Mar 2020.
- Derived from this study: PubMed 41193504Schultz J, Patel PA, Aires R, Wissing L, Glatte P, Seifert M, Gentzel M, Fitze G, Doyle AM, Sandoval-Guzman T. Human fingertip regeneration follows clinical phases with distinct proteomic signatures. NPJ Regen Med. 2025 Nov 5;10(1):51. doi: 10.1038/s41536-025-00441-y.
- Derived from this study: PubMed 29019891Schultz J, Leupold S, Grahlert X, Pfeiffer R, Schwanebeck U, Schrottner P, Djawid B, Artsimovich W, Kozak K, Fitze G. Study protocol for a randomized controlled pilot-trial on the semiocclusive treatment of fingertip amputation injuries using a novel finger cap. Medicine (Baltimore). 2017 Oct;96(41):e8224. doi: 10.1097/MD.0000000000008224.
- Individual participant dataSharing planned: No
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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.
Guido Fitze, Prof. Dr. study director
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Finger cap and Film Dressing in people with Finger Injuries, run by Orthopädie- und Rehatechnik Dresden GmbH at 1 site in Germany.
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 4 inclusion and 13 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 2 Mar 2020. 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 Germany. 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?
Acceptance (time frame: At day 28 after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089060, which also lists 2 linked publications.
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 2 Mar 2020.