Silicone Finger Cap ("Silikonfingerling")

Status Completed

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Finger Injuries

Clinical Trial Details

NCT number	NCT03089060
Study type	Interventional
Source	Orthopädie- und Rehatechnik Dresden GmbH
Contact
Status	Completed
Phase	N/A
Start date	September 21, 2017
Completion date	February 3, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00300092` - Pediatric Fingertip Injuries:Are Antibiotics Required?	Phase 2
Not yet recruiting	`NCT05003596` - Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand	Phase 2/Phase 3
Terminated	`NCT02548260` - Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression	N/A
Completed	`NCT01767727` - Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps	N/A
Completed	`NCT03228849` - Comparison of New Suture Anchor Technique for Bony Mallet Injury Versus Conservative Treatment	N/A
Completed	`NCT00130104` - Transthecal Metacarpal Block Versus Traditional Digital Block for Painful Finger Procedures in Children	Phase 4
Completed	`NCT03717220` - Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps	N/A
Active, not recruiting	`NCT04961879` - Dorsal Finger Reconstruction	N/A
Recruiting	`NCT04631081` - Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation	N/A
Recruiting	`NCT04312412` - Outcome of the Treatment of Flexor Tendon Injuries
Terminated	`NCT02058303` - Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery	Phase 4
Withdrawn	`NCT03968835` - A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
Completed	`NCT01927003` - Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.