NCT03089060

Silicone Finger Cap ("Silikonfingerling")

Completed NA Last updated 2 March 2020

What this trial tests

NA trial testing Silicone Finger cap in Finger Injuries in 22 participants. Completed in 3 February 2020.

Timeline

21 September 2017

Primary endpoint
3 February 2020

3 February 2020

Quick facts

Lead sponsor	Orthopädie- und Rehatechnik Dresden GmbH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	21 September 2017
Primary completion	3 February 2020
Estimated completion	3 February 2020
Sites	1 location across Germany

Drugs / interventions tested

• Silicone Finger cap
• Film Dressing

Conditions studied

• Finger Injuries — all drugs for Finger Injuries →

Sponsor

Orthopädie- und Rehatechnik Dresden GmbH

Who can join

2 and older, any sex, with Finger Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Semi-occlusive management of fingertip injuries with finger caps: A randomized controlled trial in children and adults.
   Schultz J, Wruck JE, Trips E, Pfeiffer R, et al · · 2022 · cited 5× · PMID 35801770 · DOI 10.1097/md.0000000000029324
2. Study protocol for a randomized controlled pilot-trial on the semiocclusive treatment of fingertip amputation injuries using a novel finger cap.
   Schultz J, Leupold S, Grählert X, Pfeiffer R, et al · · 2017 · cited 2× · PMID 29019891 · DOI 10.1097/md.0000000000008224
3. Human fingertip regeneration follows clinical phases with distinct proteomic signatures.
   Schultz J, Patel PA, Aires R, Wissing L, et al · · 2025 · cited 1× · PMID 41193504 · DOI 10.1038/s41536-025-00441-y