Tolerance Study of the Silicone Bands on Medical Compression Stockings

This study is currently recruiting participants.
Verified July 2012 by Laboratoires Innothera
Sponsor:
Information provided by (Responsible Party):
Laboratoires Innothera
ClinicalTrials.gov Identifier:
NCT01486225
First received: August 10, 2011
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Skin Lesions
Device: Innothera's brand Stockings
Other: Stockings other than Innothera's brand
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings

Further study details as provided by Laboratoires Innothera:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Patient will be followed during 5 days from the time that lessions occurs


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Medical compression stockings
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486225

Locations
France
Hôpitaux de Brabois CHU de Nancy Recruiting
Nancy, France, 54500
Contact: Laurence Darenne    +33 3 83 15 71 45      
Principal Investigator: Annick Barbaud, MD Professor         
Sub-Investigator: Jean-François CUNY, MD         
Sub-Investigator: Julie WATON, MD         
Sponsors and Collaborators
Laboratoires Innothera
Investigators
Principal Investigator: Annick BARBAUD, MD Professor CHU de Nancy
  More Information

No publications provided

Responsible Party: Laboratoires Innothera
ClinicalTrials.gov Identifier: NCT01486225     History of Changes
Other Study ID Numbers: CVE401-10
Study First Received: August 10, 2011
Last Updated: July 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 17, 2014