Tolerance Study of the Silicone Bands on Medical Compression Stockings

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01486225
• Date of registration: 10/08/2011
• Prospective Registration: Yes
• Primary sponsor: Laboratoires Innothera
• Public title: Tolerance Study of the Silicone Bands on Medical Compression Stockings
• Scientific title: Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings
• Date of first enrolment: November 2011
• Target sample size: 3
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01486225
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Annick BARBAUD, MD Professor
• Affiliation: CHU de Nancy

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Skin Lesions

Intervention(s)

Device: Innothera's brand Stockings

Other: Stockings other than Innothera's brand

Primary Outcome(s)

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]

Secondary ID(s)

CVE401-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors