Finger Injuries Clinical Trial
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")
Verified date | February 2020 |
Source | Orthopädie- und Rehatechnik Dresden GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | February 3, 2020 |
Est. primary completion date | February 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Carl Gustav Carus | Dresden | Saxony |
Lead Sponsor | Collaborator |
---|---|
Orthopädie- und Rehatechnik Dresden GmbH | Technische Universität Dresden |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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). | |
Secondary | Re-epithelialization rate | Measuring of re-epithelialization rate | At Day 14, 28, 42 resp. till wound healing is complete. | |
Secondary | Tissue growth | Determination of tissue growth during treatment using medical ultrasound | At day 28 and 4 months. | |
Secondary | Function of the regenerated perspiratory glands | Ceck of function of the regenerated perspiratory glands using Moberg's Ninhydrin test. | At 4 months (Day 122). | |
Secondary | 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). | |
Secondary | Cosmetic aspects, measured using a check list/questionnaire | Checking a list of common deformities i.e. scarring, split nails. | At 4 months (Day 122). |
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