Tolerance Study of the Silicone Bands on Medical Compression Stockings

NCT ID: NCT01486225

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-10-31

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.

Conditions

Skin Lesions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Innothera's brand Stokings

Innothera's branded grip-top silicone band stokingc

Group Type: OTHER

Innothera's brand Stockings

Intervention Type: DEVICE

15 patients having used Innothera branded Stocking

Other than Innothera's brand

Group Type: OTHER

Stockings other than Innothera's brand

Intervention Type: OTHER

15 patients having used any other brand than Innothera's brand stockings

Interventions

Innothera's brand Stockings

15 patients having used Innothera branded Stocking

Intervention Type: DEVICE

Stockings other than Innothera's brand

15 patients having used any other brand than Innothera's brand stockings

Intervention Type: OTHER

Other Intervention Names

Medical compression stockings; Other Names: Medical compression stockings

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Innothera

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annick BARBAUD, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

Hôpitaux de Brabois CHU de Nancy

Nancy, , France

Countries

France

Other Identifiers

CVE401-10

Identifier Type: -

Identifier Source: org_study_id