Tolerance Study of the Silicone Bands on Medical Compression Stockings

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.

To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.

• Device: Innothera's brand Stockings
  15 patients having used Innothera branded Stocking
  Other Name: Medical compression stockings
• Other: Stockings other than Innothera's brand
  15 patients having used any other brand than Innothera's brand stockings
  Other Names:

  • Other Names:
  • Medical compression stockings

• Innothera's brand Stokings
  Innothera's branded grip-top silicone band stokingc
  Intervention: Device: Innothera's brand Stockings
• Other than Innothera's brand
  Intervention: Other: Stockings other than Innothera's brand

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.