Silicone Finger Cap ("Silikonfingerling")
Silicone Finger Cap ("Silikonfingerling")
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.
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