APPENDIX 1 Clinical Practice THE USE OF LARVAE IN WOUND MANAGEMENT Definition: Sterile larvae of the common green-bottle (Lucilia sericata) are used to treat most types of sloughy, infected or necrotic wounds. They may also reduce wound pain and stimulate the formation of granulation tissue (NHS Fife (2010) Wound Formulary and Wound Management Guidelines,) 1 POLICY STATEMENT 2 1.1 NHS Fife Community Health Partnerships (CHPs) acknowledge the use of Larvae in the treatment of appropriately assessed wounds. 1.2 Only medical grade larvae currently on contract to NHSScotland must be used for this purpose. LOCATION All clinical areas including domiciliary settings within NHS Fife. 3 RESPONSIBILITY 3.1 To ensure best practice in the application of larvae therapy, NHS Fife CHPs will expect registered nursing/ pharmacy/ medical practitioners to (where relevant to their role): a) Carry out a full assessment of need which identifies the wound, which would respond most appropriately to larvae therapy. b) Ensure that the correct treatment of larvae therapy is given as prescribed in collaboration with relevant medical, registered nursing staff and pharmacy staff. c) Ensure that treatment is consistent with NHS Fife Policy on Obtaining Informed consent for Treatment (2009). d) Supply patients with the appropriate patient information leaflet. (See appendix C) e) Accurately record the application, monitoring, removal and disposal of the ‘Larvae’ f) Apply NHS Fife Infection Control Policy and Procedures g) Larvae therapy must only be undertaken by a registered practitioner who has had previous practical experience in the management of wounds, and a thorough understanding of the wound healing process. h) Have undertaken an educational programme in larval therapy (nursing staff only) 4. OPERATIONAL PROCEDURE 4.1 4.2 Wound Assessment 4.1.1 Larvae Therapy is suitable for most types of infected, sloughy or necrotic wounds irrespective of aetiology. The exceptions to this are: a) Fistulae; b) Wounds that connect with the abdominal cavity; c) Wounds that bleed readily; d) Patients receiving anticoagulant therapy; e) Wounds close to major blood vessels or nerves; f) Any situations where blood supply is insufficient to permit healing to take place. 4.1.2 Dry necrotic wounds require wound bed management prior to the application of larvae in order to breakdown eschar formation 4.1.3 Prior to undertaking larvae therapy, the registered practitioner must check for interactions/ contra- indications with other wound care products e.g. hydrogels. 4.1.4 Larvae must only be used where the patient has given informed consent to the use of this therapy. This must be clearly documented in the patient’s nursing and medical records including date of review. Order, supply and storage of larvae 4.2.1 Larvae are available in two forms; a) “Free-range” larvae (LarvaE), which are applied directly to the wound b) Or in “Bags” (BioFOAM); where the larvae are contained in small fabric bags that are placed directly on the wound surface. 4.2.2 N.B. For ‘free range’ Larvae a retention system is required. The following retention systems are available for use: a) Nylon net dressings – for wounds that are isolated and easy to dress; b) Nylon net system sleeve – for extensive or circumferential wounds (arm and legs); c) Nylon Net Boot – for extensive wound on limb extremities (hand, feet, stumps); d) Half Boot – for toes. N.B. Further guidance can be obtained from www.biomonde.com/resources/literature 4.2.3 To calculate the number of larvae required: 4.2.3.1 For free range Larvae- a simple calculator can help to determine the number of pots of Larvae required for the wound (see Appendix A). 4.2.3.2 For BioFOAM- bags should be sized to allow overlap of the wound margin (see Appendix B) 4.2.4 Larvae should be used on the day of delivery; in exceptional circumstances, they may be stored overnight at room temperature (in the delivery box) away from direct heat. 4.2.5 In Community settings 4.2.5.1 In community settings upon receipt of a prescription (GP10/ GP 10 (N)) the Community Pharmacist can order larvae by telephone 0845 230 1810 or fax 01656 668047 during working hours from Monday to Friday. N.B The ability to manage larvae therapy must be considered when commencing therapy i.e. weekend cover required. 4.2.5.2 Orders received before 12.00 hours may be dispatched by a courier for delivery (excluding Sunday) the following day. Contact BioMonde on tel: 08452301810 or email orders@biomonde.com for further advice. 4.2.5.4 When placing an order the following details are required:a) Delivery address for the surgery, pharmacy or clinic; b) The product required including order code; c) Preferred date and time of delivery; d) Address to which the invoice should be sent. 4.2.6 In Community Hospital settings Larvae can be obtained via the Pharmacy Department at Victoria or Queen Margaret Hospital. 4.2.7 4.2.8 Monitoring 4.2.7.1 Exudate production is often increased during larvae therapy as the larvae liquefy the dead tissue and which may be accompanied by an increase in wound odour. This is only temporary and usually resolves after the first dressing change. 4.2.7.2 Patients with ischaemic wounds/arterial disease/ neuropathy may complain of increased wound pain during treatment. This is thought to result from changes in wound pH. 4.2.7.3 If the pain experienced becomes a problem and cannot be controlled adequately by analgesics, then the larvae may be removed earlier than usual or moved to alternative site in the wound bed where they maybe better tolerated (bags only). 4.2.7.4 Outer bandages, absorbent padding and gauze must be checked on a daily basis and changed if they become excessively wet or malodorous. 4.2.7.5 Larvae can be left on a wound bed for 3 (free range) -5 (bags) days. If their growth rate is reduced it may be appropriate to leave them an additional day. 4.2.7.6 In some instances if the wound is not sufficiently moist the larvae may require additional humidification. This can be undertaken by placing 5-10mls of sterile water or 0.9& sodium chloride through the mesh. 4.2.7.7 For further advice and support (24hours) contact local BioMonde representative on 07896 687010 Removal of Larvae from a wound 4.2.8.1 Larvae can be removed from the wound bed with a gloved hand or a pair of forceps. 4.2.8.2 If the larvae have found their way into the depths of a wound they will generally come to the surface if the wound is irrigated with a stream of sterile water or 0.9 % Sodium Chloride. N.B. do not be concerned if all the maggots are not returned 4.2.8.3 4.2.9 4.2.10 When all Larvae have been removed, reassess the wound to see if further Larvae therapy is required or a change to conventional therapy as indicated. Disposal of Larvae 4.2.9.1 Larvae are regarded as Grade A medical waste for incineration and must be disposed of in accordance with NHS Fife Infection Control Manual (2010). 4.2.9.2 The special containers for disposal must be left with the patient on application of the Larvae in the event they require to be removed quickly. 4.2.9.3 In Hospital settings: They should be placed in the supply containers which convert into a clinical waste bin and disposed of in clinical waste bags. 4.2.9.4 In Community settings: They must be disposed of in the supply container and double bagged in clinical waste bags. Special uplift of the larvae requires to be arranged with the transport department in the Area Distribution Centre (01592 657335). Patient Death If a patient dies unexpectedly during Larvae therapy, the Larvae should be removed from the wound prior to the transfer of the patient to the mortuary and disposed of as discussed in 4.2.9 4.2.11 Patient education 4.2.9.5 To gain informed consent and promote compliance it is important that the patient has been provided with a ‘Patient Information Leaflet on Larvae Therapy’. (See appendix C). 4.2.9.6 Patients must be provided with: a) Details of who to contact during normal working hours; b) NHS 24 out with normal working hours including bank holidays/ weekends; In the event that removal is required. 4.2.9.7 5 RISK MANAGEMENT 5.1 Administering Nurse responsibility: It is the responsibility of the administering nurse following any adverse incident or near miss to: a) Comply with NHS Fife (2010) COPM 15-1 and NHS Fife (2006) Incident Management Policy and a Incident/Near Miss Reporting Form must be completed and given to the line manager as soon as practicable. b) The nurse must report any symptoms that are unrelated to the treatment to the patient’s General Practitioner (NMC, 2007). c) The nurse must report any issues with larvae therapy to the BioMonde clinical helpline tel: 08452306806 d) A “yellow card” must be completed if it is suspected that an adverse reaction may be related to the larvae or a combination of medicines. Further information can be obtained on the “yellow card” scheme from http://yellowcard.mhra.gov.uk/ 5.2 6 The patient must be advised to report any adverse incidents to the nursing staff / GP. Line Managers Responsibility: It is the responsibility of the line manager following any adverse incident or near miss to ensure that procedures are followed in accordance with NHS Fife (2010) COPM 15-1 Management of Medication Incidents and NHS Fife (2006) Incident Management Policy GP/12 REFERENCES BioMonde resources accessed via www.biomonde.com NHS Fife (2006) Incident Management Policy GP/I2 NHS Fife NHS Fife (2009) Guidance on Obtaining Informed Consent to Treatment NHS Fife. (2010) Infection Control Manual. NHS Fife NHS Fife (2010) COPM 15-1: Administration of Medicine- Management of Medication Incidents NHS Fife NHS Fife (2010) Wound Formulary and Wound Management Guidelines, 4th Edition, NHS Fife Nursing and Midwifery Council, (2007). Standards for Medicines Management London: NMC 7 APPENDICIES Appendix A:- Larvae Calculator Appendix B:- BioFOAM ordering guide Appendix C:- Patient Information Leaflet Sterile Larvae Therapy Appendix A LarvaE Calculator (www.biomonde.com) Appendix B Appendix C PATIENT INFORMATION LEAFLET STERILE LARVAE THERAPY CONTACT DETAILS For specific information on your wound you should contact: PROFESSIONAL ________________________________________________ CONTACT DETAILS ____________________________________________ _______________________________________________________________ TYPE OF DRESSING SYSTEM IN USE____________________________ LENGTH OF TREATMENT____________________________________ Each application of Sterile Larvae is generally left in place for about three days. It is not possible to predict how long a course of treatment will take. Sometimes a wound is completely cleansed by a single application of Sterile Larvae but other wounds may require two or more treatments to achieve the desired effect. CHANGES IN YOUR WOUND DURING STERILE LARVAE THERAPY You may experience some change in your wound during Sterile Larvae therapy; The wound may become a little more wet than usual or show the presence of a dark red or pink discharge. This is due to the action of the Larvae breaking down dead tissue in the wound; Sometimes a wound that contains a lot of dead tissue will develop a smell during treatment. This is due to the activity of the Larvae and should disappear when the dressing is changed; Most people are unaware of the Larvae’ presence. A small number of people claim that they can feel the Larvae moving but only describe this as a tickling sensation; Some patients, particularly those with poor circulation report that their wounds become more painful during Sterile Larvae therapy. This can usually be controlled with medication. Your doctor will be able to advise you of the action to take in the event your wound becomes more painful. Some patients have found that pain associated with infected wounds is reduced following Sterile Larvae therapy. ACTIVITY TO AVOID DURING STERILE LARVAE THERAPY It is possible to carry out most normal activities whilst undergoing this therapy. Ideally you should not: Bathe or immerse your wound in water, particularly in the early stages of treatment. Although the Larvae are unlikely to drown excessive moisture can loosen the retaining dressing and allow them to escape; Sit with the wound too close to a fire or other source of heat as the Larvae may dry out; Sit or walk on a wound dressed with Larvae as the Larvae will be squashed. If you have any concerns when the Sterile Larvae are in place contact ___________ ____________________________________________________as soon as possible. APPENDIX 2 How many maggots have been used since they were first introduced – broken down by year and supplier? Description / Year MAGGOTS MAGGOTS (Biofoam) DRESSING 2.5x4cm (1) MAGGOTS (Biofoam) DRESSING 2x2cm (1) MAGGOTS (Biofoam) DRESSING 5x5cm (1) MAGGOTS (Biofoam) DRESSING 7x12cm (1) MAGGOTS (Biofoam) DRESSING 7x7cm (1) MAGGOTS BIO BAG 2.5cm x 4cm (BB50) (1) MAGGOTS BIO BAG 5cm x 6cm (BB200) (1) MAGGOTS, Larvae (Large Biobag) 2003 2004 2005 2006 16 2 44 4 5 9 2007 2008 1 1 2009 2010 2011 5 2012 2013 2 1 1 ZOOBIOTICS 4 7 1 8 2 ZOOBIOTICS 5 9 3 3 1 ZOOBIOTICS 3 2 4 3 1 2 23 18 10 Supplier SURGICAL MATERIALS LAB ZOOBIOTICS 1 11 2014 ZOOBIOTICS 1 ZOOBIOTICS ZOOBIOTICS STRATHMANN LIMITED APPENDIX 3 How much has been spent on buying maggots? Year 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Cost £1,124 £2,999 £4,837 £2,925 £2,250 £3,804 £1,733 £4,789 £976 £468 £1,106 £27,012 APPENDIX 4 How much has been spent on buying the honey and where is it bought from? Drug Description ACTIVON HONEY PASTE 25g (12) ACTIVON MANUKA HONEY TUBE 25g (12) ACTIVON MANUKA HONEY TUBE 25g (1) ACTIVON TULLE 10x10cm DRESSING ACTIVON TULLE 10x10cm DRESSING ACTIVON TULLE 5x5cm DRESSING ALGIVON ALGINATE10x10cm DRESSING ALGIVON ALGINATE 5x5cm DRESSING MESITRAN 10x10cm DRESSING MESITRAN 10x10cm MESH DRESSING MESITRAN 17.5x10cm DRESSING MESITRAN 20x15cm DRESSING MESITRAN BORDER 10x10cm DRESSING MESITRAN BORDER 15x13cm SACRAL DRESSING MESITRAN BORDER 15x15cm MESITRAN OINTMENT (15g) MESITRAN OINTMENT (50g) MESITRAN S OINTMENT (15g) 2005 2006 2007 2008 10 11 1 12 2009 3 2011 2012 2013 2 Supplier ALLIANCE HEALTHCARE LTD (002972) AAH PHARMACEUTICALS (000401) 110 0 2010 42 AAH PHARMACEUTICALS (000401) 44 ADVANCIS MEDICAL (001923) 7 20 50 170 410 280 155 77 74 ADVANCIS MEDICAL (001923) 10 125 230 335 145 90 24 52 ADVANCIS MEDICAL (001923) 245 485 805 565 290 ADVANCIS MEDICAL (001923) 125 405 640 485 280 ADVANCIS MEDICAL (001923) 920 1790 1650 1290 370 380 180 ASPEN MEDICAL EUROPE LTD (000746) 620 1000 480 290 340 240 110 ASPEN MEDICAL EUROPE LTD (000746) 20 30 10 10 50 20 10 AAH PHARMACEUTICALS (000401) 40 10 60 40 40 20 20 AAH PHARMACEUTICALS (000401) 160 210 160 80 10 10 10 10 30 10 10 174 351 235 39 1 4 25 29 34 48 21 14 11 5736.15 9234.83 8,861.04 8946.63 8543.16 6306.03 3486.46 ASPEN MEDICAL EUROPE LTD (000746) AAH PHARMACEUTICALS (000401) AAH PHARMACEUTICALS (000401) ASPEN MEDICAL EUROPE LTD (000746) AAH PHARMACEUTICALS (000401) AAH PHARMACEUTICALS (000401) 10 174 56 89 60 1 1346.23 1454.45