Tolerance Study of the Silicone Bands on Medical Compression Stockings

Skin Lesions Clinical Trial

Official title:

Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01486225
• Other study ID #: CVE401-10
• Status: Terminated
• Phase: Phase 4
• First received: August 10, 2011
• Last updated: August 7, 2014
• Start date: November 2011
• Est. completion date: October 2013

Study information

• Verified date: July 2012
• Source: Laboratoires Innothera
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Lesions

Intervention

Device:
• Innothera's brand Stockings
15 patients having used Innothera branded Stocking

Other:
• Stockings other than Innothera's brand
15 patients having used any other brand than Innothera's brand stockings

Locations

Country	Name	City	State
France	Hôpitaux de Brabois CHU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Innothera

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings	Patient will be followed during 5 days from the time that lessions occurs	within 5 days from skin lesion started	No