Clinical trial NCT01486225: Tolerance Study of the Silicone Bands on Medical Compression Stockings
Official title: Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Skin Lesions
Lead sponsor: Laboratoires Innothera
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings
timeFrame: within 5 days from skin lesion started
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Hôpitaux de Brabois CHU de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Annick BARBAUD, MD Professor
role: PRINCIPAL_INVESTIGATOR
References: