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