An innovative solution for night bandaging

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Jemimah Higgins
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1 An innovative solution for night bandaging Distrubuted in the UK by Haddenham Healthcare Ltd

2 CONTENTS INTRODUCING MOBIDERM AUTOFIT 2 ABOUT AND CARE INSTRUCTIONS 3 SIZING AND ORDER CODES 4 CLINICAL TRIAL INFORMATION 5 TERMS & CONDITIONS SETTLEMENT DELIVERY/HANDLING PRICES RETURNS NON DELIVERY WARRANTY LIABILITY Nett 30 days. Accounts payable monthly. We reserve the right to charge interest on amounts outstanding over 30 days at the current bank rate + 3% on a daily basis. Standard charge of 3.90 ex VAT applies to each requested delivery. Additional charge may be levied for courier service. Delivery times are approximate and are dependent on the order being received and complete. Haddenham Healthcare Ltd cannot be held responsible for a courier s failure to deliver to the specified time due to adverse weather conditions or other exceptional circumstances. Subject to change without notice. Exclude VAT. Customer liability returns for Credit Note are subject to a 5.00 handling charge per item. Returned goods must be in a saleable condition and have a minimum of 18 months shelf life remaining. Non receipt of goods must be notified, in writing, within 21 days of the date on the despatch note/invoice. Products are guaranteed against defects in material and manufacture. Specific warranty terms vary per product. Please consult each individual product s Instructions for Use for details. Responsibility for the selection and application of products rests with the professional staff treating the patient. Haddenham is a registered trademark of Haddenham Healthcare Ltd, UK; Mobiderm is a registered trademark of Thuasne, France. Images on pages 2, 3, 5, 6 and front cover are reprinted with permission from Thuasne, France Haddenham Healthcare Ltd.

The standard, self-adjustable sleeve, to adapt to

and thumb for the upper limb lymphoedema For

For all stages of the lymphoedema To be used

who wish autonomous control of their oedema For

tightening notches: adaptation to each patient s

Adjustment marks: precise and repeatable

variation Velcro fasteners: instant setup and

3 The standard, self-adjustable sleeve, to adapt to each patient s individual morphology and evolution overtime! Description : Self-adjustable sleeve, with mitten and thumb for the upper limb lymphoedema For which patients? For all stages of the lymphoedema To be used during the maintenance phase or at the end of the reduction phase For patients presenting dysmorphims or progressive oedema For patients who wish autonomous control of their oedema For patients who need a product immediately Several tightening notches: adaptation to each patient s individual morphology. Adjustment marks: precise and repeatable application, control of the œdema volume variation Velcro fasteners: instant setup and high performance Sleeve with attached retractable mitten: limits the risk of œdema migration; the hand can be freed for usual tasks Semi-open garment: Easy to put on, easy to take off! 2

ABOUT MOBIDERM AUTOFIT Maintaining Results In order to maintain results obtained during the intensive phase of bandage application, the patient must have access, during the maintenance phase, to a

Taking over from day-time compression and as a genuine alternative to self-bandage, garments have been developed to continue mobilising the oedema during the night, and thereby reinforce the effects

They are fitted with the device on the inside, which helps promote lymphatic circulation with micro-massages.

An unintrusive and discreet treatment: Works during sleep without disturbing it. Rapid application:a single garment to put on.

4 ABOUT MOBIDERM AUTOFIT Maintaining Results In order to maintain results obtained during the intensive phase of bandage application, the patient must have access, during the maintenance phase, to a permanent, efficient and comfortable treatment. His/her autonomy will contribute to observance of the treatment prescribed and can guarantee its long-term success. Taking over from day-time compression and as a genuine alternative to self-bandage, garments have been developed to continue mobilising the oedema during the night, and thereby reinforce the effects of the day-time treatment. These garments are made of a soft elastic material designed to deliver a soft pressure, well-accepted by patients in the night-time phase. They are fitted with the device on the inside, which helps promote lymphatic circulation with micro-massages. A unique night-time treatment: Helps preserve effects achieved by day-time compressionand continue the night-time treatment without interruption. An unintrusive and discreet treatment: Works during sleep without disturbing it. Rapid application:a single garment to put on. Pads Mobiderm Epidermis Dermis Care instructions Close the velcro fasteners prior to washing. Two wash options are possible: Hand wash: Soak the device in cold soapy water, rub with a clean sponge and squeeze the water out by pressing. Machine wash: Use the wool cycle, at cold temperature, and use a laundry net. Hand squeeze the water out by pressing. In both cases, let dry at room temperature away from any direct source of heat. When not used, the sleeve should be kept flat, with the velcro fasteners closed. If it must be folded, position the hooks pointing outward. Main components: Outer layer of the garment: 59 % polyamide, 41 % elastane along the arm: adhesive non-woven, polyurethane foam (15 x 15 mm cubes) hand level: adhesive non-woven, polyethylene foam (5 x 5 mm cubes) 3

5 SIZING & CODES g c d b All measurements in cm SIZING Circumferences b Palm at fold of thumb c Wrist d Mid-point of forearm g Axilla Lengths c-g Normal c-g Long CLINIC ORDER CODES ARM LENGTH PRICE RIGHT RN RN RN RN RN RN LEFT LN LN LN LN LN LN RIGHT RL RL RL RL RL RL LEFT LL LL LL LL LL LL NORMAL LONG DRUG TARIFF PIP CODES ARM LENGTH RIGHT LEFT RIGHT LEFT NORMAL LONG 4

6 SAFETY AND EFFICACY OF Authors: Dr Mestre-Godin S 1, Pasqualini M 2, Dr Ben Amor C 2, Pr Quéré I 1 Affiliations: 1 Hôpital Saint-Eloi, Montpellier, FRANCE - 2 THUASNE, Levallois Perret, FRANCE N ID RCB: 2014-A INTRODUCTION: Rebound effect of lymphedema volume is observed after Decongestive Lymphedema Therapy (DLT) in patients with Breast Cancer Secondary Lymphedema (BCSL). Successful outcomes of lymphedema long term treatments are depending on patient compliance. OBJECTIVE: The main objective of this proof of concept study was to assess the efficacy and safety of Autofit as night treatment for maintenance phase after DLT on top of daily Thuasne Lymphology compression. Secondary objectives were to assess compliance and satisfaction of patients equipped with Mobiderm Autofit device. METHOD/DESIGN: INTENSIVE PHASE DLT n = 40 Stages II et III DLT D0 n = 40 Randomisation Stages II et III MARILYN: MAINTENANCE PHASE Gp I n = 20 Day hosiery + Night-time Autofit Gp II n = 20 Day hosiery only D30 Primary Outcome D90 Day hosiery + Night-time Autofit n = 40 RESULTS: Description of the population (Years) - Mean age : 67 - Mean time since diagnosis of breast cancer: 11 - Mean time since lymphedema diagnosis: 7 - Lymphedema Stages: II, III COMPLIANCE RESULTS*: How often have you worn Autofit during the study? (both Gp I and II) 90 % of patients have worn Autofit every night 10 % 90 % Every night 4 to 6 days per week SATISFACTION RESULTS*: How would you rate Autofit? Easy / Very easy to put on 70 % of patients Quick fitting 85 % of patients Useful self adjustement 89 % of patients Easy / Very easy to take off 98 % of patients Comfortable 90 % of patients 82 % of the patients already wearing compression do prefer Autofit! 5 * Patient questionnaire submitted to each enrolled patient at the end of the study

7 AUTO-ADJUSTABLE NIGHT ARM SLEEVE (AUTOFIT) IN THE MANAGEMENT OF UPPER LIMB LYMPHEDEMA: MARILYN TRIAL EFFICACY RESULTS: 100 From initiation of DLT Mean volume excess variation (cm 3 ) DLT/D0 DLT/D30 DLT/D D0/D30 D0/D90 From day 0 Group I Group II Absolute mean volume excess variations (cm 3 ) Vol excess variation D0/D30 (%): 1,80 in Gp I vs 3,20 in Gp II (NS) At day 30, 85 % of DLT effect is maintained in Gp I vs 54 % in Gp II Volume variation in High Responders (HR) patients (cm 3 ) Autofit benefit is more pronounced among High Rresponders DLT (Loss of 35 % during DLT - POLIT study, JMV 2014) Mean volume excess (cm 3 ) Rebound Effect 500 HR Gp I 400 HR Gp II DLT MAINTENANCE D0 D30 D90 CONCLUSION / DISCUSSION: Results of primary criterion suggest that Autofit tends to limit rebound effect of lymphedema after DLT, especially in patients who were strongly responsive to DLT. Between D30 and D90, study period in which all 40 patients were fitted with the study medical device, a lymphedema volume stabilizing effect is observed. Results of secondary criteria show that Autofit displays favorable characteristics that increase patient's independence from specialized medical staff or relatives while keeping high level of patient's compliance in maintenance phase. Autofit arm sleeve could offer interesting benefit to patients for self management of this chronic pathology. 6

8 Haddenham Healthcare Ltd, Crendon House, Crendon Industrial Park, Long Crendon, Bucks HP18 9BB Tel: Fax: Website:

Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT

Support Care Cancer (2017) 25:2455 2462 DOI 10.1007/s00520-017-3652-5 ORIGINAL ARTICLE Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM Autofit) in maintenance phase of upper limb