Tolerance Study of the Silicone Bands on Medical Compression Stockings

Exploratory Comparative Single-blind Study Evaluating Tolerability 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.

Study Overview

• Status: Terminated
• Conditions: Skin Lesions
• Intervention / Treatment: Device: Innothera's brand Stockings; Other: Stockings other than Innothera's brand

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54500
    • Hôpitaux de Brabois CHU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Innothera's brand Stokings; Innothera's branded grip-top silicone band stokingc	Device: Innothera's brand Stockings; 15 patients having used Innothera branded Stocking; Other Names: Medical compression stockings
Other: Other than Innothera's brand	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Laboratoires Innothera
• Investigators: Principal Investigator: Annick BARBAUD, MD Professor, CHU de NANCY

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: CVE401-10