Silicone Finger Cap ("Silikonfingerling")

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.

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 Overview

• Status: Completed
• Conditions: Finger Injuries
• Intervention / Treatment: Device: Silicone Finger cap; Device: Film Dressing

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • University Hospital Carl Gustav Carus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silicone Finger Cap; Patients randomized to this arm will be treated with the novel silicone finger cap for the first two weeks of treatment.	Device: Silicone Finger cap; Treatment with silicone finger cap; Device: Film Dressing; Treatment with conventional film dressing
Active Comparator: Film dressing; Patients randomized to this arm will be treated with conventional film dressings for the first two weeks of treatment.	Device: Silicone Finger cap; Treatment with silicone finger cap; Device: Film Dressing; Treatment with conventional film dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day 28 after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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.	Up to 42 days resp. till wound healing is complete.
Microbiological colonization	Changes in microbiological colonization in the wound during treatment using microbiological analysis.	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	At Day 14, 28, 42 resp. till wound healing is complete.
Tissue growth	Determination of tissue growth during treatment using medical ultrasound	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.	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	At 4 months (Day 122).
Cosmetic aspects, measured using a check list/questionnaire	Checking a list of common deformities i.e. scarring, split nails.	At 4 months (Day 122).

Collaborators and Investigators

• Sponsor: Orthopädie- und Rehatechnik Dresden GmbH
• Collaborators: Technische Universität Dresden
• Investigators: Study Director: Guido Fitze, Prof. Dr., Technical University Dresden

Publications and helpful links

General Publications

• Schultz 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): February 3, 2020
• Study Completion (Actual): February 3, 2020

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Infection; Occlusive Dressings; Pediatric Surgery; Fingertip Amputation; Fingertip Regeneration; Silicone Finger Cap
• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries; Finger Injuries
• Other Study ID Numbers: ORD0001/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No