Tolerance Study of the Silicone Bands on Medical Compression Stockings

NCT01486225 | Terminated Phase 4

• 1 other identifier: CVE401-10
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Innothera's brand Stokings

OTHER

Innothera's branded grip-top silicone band stokingc

Device: Innothera's brand Stockings

Other than Innothera's brand

OTHER

Other: Stockings other than Innothera's brand

Interventions

Innothera's brand Stockings DEVICE

15 patients having used Innothera branded Stocking

Also known as: Medical compression stockings

Innothera's brand Stokings

Stockings other than Innothera's brand OTHER

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

Also known as: Other Names:, Medical compression stockings

Other than Innothera's brand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to local anesthetics (lidocaine, etc.).
• History of anaphylactic shock.
• 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.
• 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:

Sponsors & Collaborators

• Laboratoires Innothera: lead

Study Sites (1)

Hôpitaux de Brabois CHU de Nancy

Nancy, 54500, France

Location

Study Officials

• Annick BARBAUD, MD Professor

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 8, 2014

Record last verified: 2012-07

Locations

FR (1)