Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03089060
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2017-03-07
Brief Title:
Silicone Finger Cap Silikonfingerling
Sponsor:
Orthopädie- und Rehatechnik Dresden GmbH
Organization:
Orthopädie- und Rehatechnik Dresden GmbH
Study Overview
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 Behandlung Von Traumatischen Substanzdefekten im Bereich Der Fingerendglieder Mittels Silikonfingerorthesen Silikonfingelingen Bei Kindern Und Erwachsenen
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None