Tolerance Study of the Silicone Bands on Medical Compression Stockings
This study is currently recruiting participants.
Verified July 2012 by Laboratoires Innothera
Sponsor:
Laboratoires Innothera
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
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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 |
Resource links provided by NLM:
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:
|
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 May 21, 2013