NCT01486225TerminatedPhase 4
Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Laboratoires Innothera
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings
Study Overview
Brief Summary
The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.
Detailed Description
To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who notified a health care professional (doctor or pharmacist) of an incident with a grip-top bands compression stocking, regardless of brand and model.
- •Subjects presenting skin lesions caused by the contact with silicone-containing grip-top bands of medical compression stockings (all brands combined).
- •Subjects for whom the incriminated stockings provide class 2 compression or higher.
- •Subjects covered by French national health insurance.
- •Subjects who give their written informed consent and who accept the constraints of the study.
Exclusion Criteria
- •Known allergy to local anesthetics (lidocaine, etc.).
- •History of anaphylactic shock.
- •Ongoing antihistamine treatment or having taken during the week before inclusion.
- •Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion.
- •Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion.
- •Phototherapy or sun exposure in the 30 days preceding the skin tests (on the back).
- •Patient having concomitantly used compression stockings and a topical corticosteroid on the thighs in the 48 hours preceding lesion onset.
- •List of diseases which will prevent a subject from participating in the study:
- •acquired, infectious or drug-induced congenital immunosuppression (systemic corticosteroid therapy, immunosuppressives, chemotherapy),
- •Congenital bullous disorder (congenital epidermolysis bullosa) or acquired bullous disorder (pemphigus, pemphigoid, dermatitis herpetiformis, linear IgA dermatosis, etc.).
- •Patients with an ongoing or previous history of mental or psychiatric disorder or condition or any other factor interfering with the ability to give informed consent.
- •Any major systemic disease making the conduct of the study or the interpretation of the results difficult.
- •Patients with ongoing or previous history of decompensated heart failure.
- •Chemotherapy or active cancer.
- •Pregnancy.
- •Patients participating in an ongoing clinical trial or in the exclusion period of a previous trial.
- •Persons deprived of their liberty by judicial or administrative decision or persons hospitalized without their consent.
- •Legally protected adults under guardianship.
- •If the patient accepts the biopsy proposed in the study:
- •Patient for whom a skin biopsy is contra-indicated or requiring antibiotic prophylaxis,
- •Anticoagulant taken during the 24 hours before inclusion.
- •Subject with history of allergy to natural or synthetic latex, chlorhexidine, known healing disorder and/or viral diseases transmissible through the blood documented by the preliminary clinical exam.
Arms & Interventions
Innothera's brand Stokings
Other
Innothera's branded grip-top silicone band stokingc
Intervention: Innothera's brand Stockings (Device)
Other than Innothera's brand
Other
Intervention: Stockings other than Innothera's brand (Other)
Outcomes
Primary Outcomes
nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings
Time Frame: within 5 days from skin lesion started
Patient will be followed during 5 days from the time that lessions occurs
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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