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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03089060
Other study ID # ORD0001/2014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2017
Est. completion date February 3, 2020

Study information

Verified date February 2020
Source Orthopädie- und Rehatechnik Dresden GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Silicone Finger cap
Treatment with silicone finger cap
Film Dressing
Treatment with conventional film dressing

Locations

Country Name City State
Germany University Hospital Carl Gustav Carus Dresden Saxony

Sponsors (2)

Lead Sponsor Collaborator
Orthopädie- und Rehatechnik Dresden GmbH Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

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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