Clinical Trial: Silicone Finger Cap ("Silikonfingerling")

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 calc

Detailed Summary:
Sponsor: Orthopädie- und Rehatechnik Dresden GmbH

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
    Safety of the finger cap in comparison to the film dressing. Patients are asked for adverse events (AE) or serious adverse events (SAE).
  • 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. ]
    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
  • 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. ]
    Necessity of unplanned dressing changes in comparison to the film dressing.
  • 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). ]
    Changes in microbiological colonization in the wound during treatment using microbiological analysis.
  • Re-epithelialization rate [ Time Frame: At Day 14, 28, 42 resp. till wound healing is complete. ]
    Measuring of re-epithelialization rate
  • Tissue growth [ Time Frame: At day 28 and 4 months. ]
    Determination of tissue growth during treatment using medical ultrasound
  • Function of the regenerated perspiratory glands [ Time Frame: At 4 months (Day 122). ]
    Ceck of function of the regenerated perspiratory glands using Moberg's Ninhydrin test.
  • Sensibility/Sensitivity of the injured fingertip [ Time Frame: At 4 months (Day 122). ]
    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
  • Cosmetic aspects, measured using a check list/questionnaire [ Time Frame: At 4 months (Day 122). ]
    Checking a list of common deformities i.e. scarring, split nails.


Original Secondary Outcome: Same as current

Information By: Orthopädie- und Rehatechnik Dresden GmbH

Dates:
Date Received: March 7, 2017
Date Started: April 2017
Date Completion: December 2019
Last Updated: March 17, 2017
Last Verified: March 2017