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Q:\CECH\Tissue Viability\1-Guidelines\Larvae Therapy SOP FINAL Larvae Therapy Standard Operating Procedure Title of Standard Operation Procedure: Larvae Therapy Reference Number: ECT003070 Version No: 2 Issue Date: May 2018 Review Date: May 2020 Purpose and Background The purpose of this document is to outline the procedure for the clinician to follow for the safe use of larvae therapy for the management of complex wounds. This is one of the treatments that is referenced in the Wound Management Policy Scope (i.e. organisational responsibility) Vital functions affected by this procedure: The organisation has a responsibility to ensure procedures are carried out in a safe and consistent way following best practice. A consistent training programme for all staff using larvae therapy be used to ensure safe working practices are followed. Pathways for assessment will ensure consistency of assessment and documentation will provide evidence to monitor this process .A patient pathway for discharge from MDGH to community will enhance patient flow and reduce hospital bed days Monitoring Compliance Requirement to be monitored. Process to be used for monitoring e.g. audit Responsible individual/ committee for carrying out monitoring Frequency of monitoring Responsible individual/ committee for reviewing the results Responsible individual/ committee for developing action plan Responsible individual / committee for monitoring action plan Assessment of patient against standard policy Assessment documentation Tissue viability and or matron Annually Tissue viability and or matron Tissue viability and matrons Tissue viability a and Matrons Escalations (if you require any further clarification regarding this procedure please contact): Sally Walsh, Tissue Viability Lead Nurse Committees / Group Date Consultation: Surgical Matron Tissue Viability Infection Control Team Risk and Governance Lead Theatres ICU Consultants Approval Committee All service lines SQS Received for information: SL 1 Consultants

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Page 1: Standard Operating Procedure Template · ICU Consultants Approval Committee All service lines SQS Received for information: SL 1 Consultants . Q:\CECH\Tissue Viability\1-Guidelines\Larvae

Q:\CECH\Tissue Viability\1-Guidelines\Larvae Therapy SOP FINAL

Larvae Therapy Standard Operating Procedure

Title of Standard Operation Procedure: Larvae Therapy

Reference Number: ECT003070 Version No: 2

Issue Date: May 2018 Review Date: May 2020

Purpose and Background

The purpose of this document is to outline the procedure for the clinician to follow for the safe use of larvae therapy for the management of complex wounds. This is one of the treatments that is referenced in the Wound Management Policy

Scope (i.e. organisational responsibility) Vital functions affected by this procedure:

The organisation has a responsibility to ensure procedures are carried out in a safe and consistent way following best practice. A consistent training programme for all staff using larvae therapy be used to ensure safe working practices are followed. Pathways for assessment will ensure consistency of assessment and documentation will provide evidence to monitor this process .A patient pathway for discharge from MDGH to community will enhance patient flow and reduce hospital bed days

Monitoring Compliance

Requirement to be monitored.

Process to be used for monitoring e.g. audit

Responsible individual/ committee for carrying out monitoring

Frequency of monitoring

Responsible individual/ committee for reviewing the results

Responsible individual/ committee for developing action plan

Responsible individual / committee for monitoring action plan

Assessment of patient against standard policy

Assessment documentation

Tissue viability and or matron

Annually Tissue viability and or matron

Tissue viability and matrons

Tissue viability a and Matrons

Escalations (if you require any further clarification regarding this procedure please contact):

Sally Walsh, Tissue Viability Lead Nurse

Committees / Group

Date

Consultation: Surgical Matron

Tissue Viability

Infection Control Team

Risk and Governance Lead

Theatres

ICU

Consultants

Approval Committee

All service lines SQS

Received for information:

SL 1 Consultants

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Operating Procedure 1. Introduction/Purpose It is the policy of MDGH that no one will be discriminated against on grounds of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex or sexual orientation. The Trust will provide interpretation services or documentation in other mediums as requested, and necessary to ensure natural justice and equality of access. 2. Scope The organisation has a responsibility to ensure procedures are carried out in a safe and consistent way following best practice. A consistent training programme following a competency framework for all staff using Larvae to be used to ensure safe working practices are followed. Pathways for assessment will ensure consistency of assessment and evidence of documentation will provide a monitoring process for this. This SOP will cover the use of Larvae in both the acute and community care within ECT. 3. Procedure The Lucilia Sericata sterile larvae are used for the debridement of wounds. It offers rapid debridement but selectively only debrides soft necrotic tissue. It also has research to support its use in combating infection caused by a range of different micro-organisms, including antibiotic resistant strains of Staph. Aureus. 3.1 Indications for Use

a) When there are large amounts of slough in a wound, which is not debrided easily using dressings. b) When the wound has large amounts of slough and the patient is Diabetic. In diabetes the immune system is compromised allowing infections to develop easily and quickly. Using Hydrogels to debride is not advisable for diabetics with compromised circulation as moisture increases the risk of infection in these patients. A wound infection in a patient with compromised circulation threatens tissue and limb viability. c) As a treatment to combat wound infection d) Control of odour

3.2 Contra-indications

a) Do not use free range larva in any body cavity. Safe to use BioBag dressings in body cavities b) Do not use in a fistulae c) Not recommended near any major blood vessels d) Dry necrotic wounds (needs to be softened first) e) Do not apply to wounds that have a tendency to bleed easily f) Do not apply to patients with clotting disorders or individuals receiving anticoagulant therapy

unless they are within therapeutic range and under constant medical supervision in a healthcare facility

3.3 Types of wounds suitable for Larvae

• Diabetic ulcers • Venous ulcers • Arterial/ischaemic ulcers • Mixed arterial–venous ulcer • Pressure ulcers • Post–traumatic wounds/ulcers i.e. haematomas • Necrotising fasciitis* post debridement • Pilonidal sinus* post-surgery • Non–healing surgical wound

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• MRSA – infected wound • Burns

Adapted from: Chan et al (2007) *See contra-indications 3.4 Clinical Assessment for Use The use of larvae is a speedy method of debriding a wound that does not remove any vitalised tissue (e.g. in surgery) It can sometimes have a reactive positive effect on the granulation tissue once the larvae are removed. Larvae can be applied either “loose” (free range) or in a “Bag” (Biobag). The decision for which to apply will depend on:

Patient preference

Location of wound

Depth of wound However, the decision and approval to administer larval therapy must be sought from an appropriate prescriber as per local policy (i.e. surgeon, medical team, tissue viability nurse/clinical nurse specialist, podiatrist, advanced nurse practitioner or non-medical prescriber). Larval therapy is indicated where an overall clinical decision has been made for the rapid debridement of devitalised tissue which is delaying wound healing. This will prepare the wound bed for products and treatments designed to enhance wound healing. Once the decision has been made to use either loose or bagged the number of larvae required will then be decided depending on the size of the wound. Appendix 4A shows the Larvae calculator for free range and Appendix 4B gives the sizes of dressings available in the “bagged” range. A “best fit” approach should be used when treating the area of slough to be removed. 3.5 Ordering of Larvae MDGH Larvae are ordered via pharmacy and will be delivered to the ward. If assessed by a Tissue Viability Nurse, nursing staff will be provided with a Larvae Therapy Support document, which will detail all of the necessary information to order the correct product. This can be given to pharmacy for ordering via Biomonde. The requisition must say:

The ward that the larvae is to be delivered

Whether loose or BioBag (bagged)

Size and Quantity of BioBag dressings/number of pots

Intended delivery day Community If assessed by a Tissue Viability Nurse, a Larvae Therapy Support document detailing the required larvae treatment will be provided. This can then be used to accurately order the product via FP10 through local pharmacist (prescription by a doctor or Independent nurse prescriber). Larvae will be delivered to the pharmacist.

Whether loose or BioBag (bagged)

Size and Quantity of BioBag dressings/number of pots

Intended delivery day

Contact details of who is to be contacted once larvae arrive at pharmacy MDGH and Community Orders will be accepted up to 2pm the day before the intended application date. To cancel an order, please contact Bio Monde before 8pm on the day before delivery. All cancellations after this time must be paid for in ful as the order will have been dispatched for delivery. Delivery is available Monday to Sunday. Bio Monde office number 0845 2301810

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Storage of Larvae

1. Keep in transit containers 2. Store at temperature of 6 degrees celsius to 25 degrees celsius (products do not need to be

refrigerated) 3. To be applied on the day of delivery (expiry date) for optimal results

Interactions with Other Medical Products

• Simultaneous treatment of the patient with systemic or topical cytostatic/cytotoxic substances would need to be discussed with the treatment prescriber.

• Topical disinfectants, local anaesthetics and some hydrogels (those that contain propylene glycol as a humectant and preservative) may have a negative effect on the growth and vitality of the larvae and consequently the treatment efficacy.

• Factors such as radiation and reduced oxygen levels e.g. caused by too tight or occlusive secondary dressing can lead to a decreased theraputic outcome.

• Bagged larvae can be used in conjunction with a non-occlusive compression bandaging system. 3.6 Application This is done following the appropriate protocol in Appendix 2 (application of loose with net sheet) Appendix 3 (application within a boot, or normal sized dressing net) or Appendix 4 (using bagged (BioBag). The larvae will be applied by a qualified clinician who is competent in the application of larvae. A care plan for application will be placed in the patients nursing notes. Consent for treatment must be agreed by the patient and documented on the assessment form. If on examination of the Larvae (before they are applied) they look dead or inactive – contact the company immediately for instructions with individual reference number on the larvae box and container. 3.7 Reasons for discontinuation

• Patient not happy with treatment or self-discontinuation • Wound starts to bleed continuously • Pain not managed with analgesia • Larvae died

3.8 Patient Monitoring Patient and wound will be reviewed daily whilst having larvae. The secondary dressing will be removed and the larvae observed for activity. The wound will then be redressed. 3.9 Maintenance BioBag larvae (up to five days duration – application day is day 0 and removed on day 4)

1. Check outer dressings daily and change where necessary (i.e. when saturated with exudate) 2. Reapply barrier where necessary to the periwound area 3. Ensure damp gauze is replaced on top of the bag at each secondary dressing change 4. Ensure that all outer/secondary dressings are not occlusive and are permeable to the air 5. Ensure that all secondary dressings are secured well to avoid slippage and to ensure surface contact of the bag is maintained 6. Do not immerse in water.

Free range larvae (up to five days duration– application day is day 0 and removed on day 4)

1. Check outer/secondary dressings daily and change where necessary (i.e. when saturated with exudate) 2. Ensure damp gauze is replaced on top of the netting at each secondary dressing change 3. Ensure a good seal is maintained between the tape and the hydrocolloid border

Removal of larvae The procedure for this is detailed in Appendix 5 for loose Appendix 6 for BioBag.

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4. Associated Documents Wound Management Guidelines 5. Consultations and Communications with Stakeholders

Standard/process/issue required to be monitored

Monitoring and Audit

Process for monitoring e.g. audit

Responsible individual /group

Frequency of monitoring

Responsible committee

1. Duties Policy review

2 years

Details of failure of larvae for the debridement of wounds (include larvae death)

All failures to be reported to the company and through Datix

Tissue Viability

Quarterly

7. Internal and External References 7.1 Internal References IC Hand Hygiene Policy ECT2494. MDGH Intranet Policies Record Keeping Guidance, for Nurses and Midwives, (2009). www.nmc-uk.org 7.2 External References Chan DC, Fong DH, Leung JY, et al (2007) Maggot debridement therapy in chronic wound care. Hong Kong Med J 13(5): 382–6

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Additional Information Abbreviations MDGH Macclesfield District General Hospital TV Tissue Viability TVN Tissue Viability Nurse SOP Standard operating procedure

Back up information (if appropriate) Abbreviations References Appendixes

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APPENDIX 1

For Free Range ‘Loose’ Maggots

Equipment 1 pot maggots per 10cm² Hydrocolloid dressing for the surrounding skin (All included in Larvae pack) Sleek or other waterproof adhesive tape Saline Retention net Community pack also contains bag for disposal Sterile non-woven swabs Patient information leaflet 1 dressing pack Low adherent pad Roll of Clinipore tape or bandage to secure secondary dressing 1 pair sterile scissors Procedure for application

Patient and medical consent must be obtained prior to treatment and Patient information given

Action Rational

1. Explain procedures to patient. Information reduces anxiety.

2. Wash hands, apply gloves and apron.

To prevent cross infection.

3. Apply hydrocolloid dressings to the

margins of the wound, leaving the

wound visible.

4. If this is not possible protect the

surrounding skin with zinc paste.

Provides a base for next dressing to be secured to. Stops tickling sensation caused by the larvae moving around on the intact skin. Protects surrounding skin from larval enzymes.

5. Remove larvae out of packaging; add

5 mls of sterile saline to pot of larvae.

This will gently agitate to remove the larvae from the walls and the lid.

6. Cut the retention net so that it is slightly larger than the wound, but slightly smaller than the hydrocolloid surround.

The retention net retains the maggots in the wound, and is secured at the edges onto the protective dressing (hydrocolloid or zinc).

7. Place the net upon the layer of absorbent gauze, pre-moistened with a small volume of sterile saline.

Irrigation facilitates removal of the maggots. Moistening the gauze overcomes surface tension.

8. Slowly pour the saline containing the larvae onto the net.

If the larvae are poured out too quickly the may run off the net.

9. Invert the net, place over the wound and secure the edges of the net to the hydrocolloid using the sleek tape provided or if using zinc paste secure

This seals the edges to ensure the maggots stay secure.

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the net onto zinc paste with bandage.

10. Place a moistened saline swab over the net and cover with an absorbent pad. Secure with tape or bandage, but do not occlude.

This prevents the maggots from drying out. The padding contains any excess exudate or liquefied necrotic tissue. Occlusive or film dressings should not be used as this will cause the larvae to suffocate.

11. Explain the patient information leaflet to the patient ensuring all questions are answered.

This helps patient understanding and reinforces informed consent.

12. Leave the patient a contact number if patient in the community.

To reassure the patient that someone can be contacted if needed.

13. Change outer padding daily. Stops maggots drowning and prevents strike through.

14. Following day of application Leave maggots on for up a further 4 days unless the patient asks for them to be removed.

The first day of application is counted as day ‘0’. Removal date is day 4.

15. Reassess wound recording effect of larvae.

Ensures documented evidence of effect of treatment.

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APPENDIX 2

Procedure for Free Range ‘Loose’ Applied in a Boot or Sleeve Application Equipment 1 pot maggots per 10cm2 Hydrocolloid dressing for the surrounding skin (All included in Larvae pack) Sleek or other waterproof adhesive tape Saline Boot retention net Community pack also contains bag for disposal Sterile non-woven swabs Patient information leaflet 1 dressing pack Low adherent pad Roll of Clinipore tape or bandage to secure secondary dressing 1 pair sterile scissors

Procedure for application

Patient and medical consent must be obtained prior to treatment and Patient information given

Action Rational

1. Explain procedures to patient. Information reduces anxiety.

2. Wash hands, apply gloves and apron.

To prevent cross infection.

3. Cut the hydrocolloid into strips about 5cm wide and apply to the foot or stump, without tension to form a band above the wound.

If hydrocolloid dressing cannot be used, strips of bandage impregnated with zinc paste may be used as an alternative.

Protect any areas intact of skin not covered by hydrocolloid dressing with a thin layer of zinc based barrier cream.

Provides a base for next dressing to be secured to. Stops tickling sensation caused by the larvae moving around on the intact skin. Protects surrounding skin from larval enzymes.

4. Add about 5mls of sterile saline to pot of maggots.

This agitates the larvae from the walls and the lid.

5. Slowly pour the saline containing the larvae into a pre moistened sterile swab.

If the larvae are poured too quickly they may run off the net.

6. Transfer larvae to wound from gauze swab.

7. Apply boot or sleeve dressing and secure with sleek onto band of hydrocolloid.

This seals the edges to ensure the maggots stay secure.

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8. When using zinc paste bandage instead of hydrocolloid it is necessary to press the net firmly down into the cream and apply additional bandage over the open end to secure.

To prevent maggots escaping.

9. Apply a saline soaked swab over the outside of the net where the larvae have been applied and cover with an absorbent pad held in place with tape or bandage as appropriate.

This prevents the maggots from drying out The padding contains any excess exudate or liquefied necrotic tissue. Do not use occlusive or film dressing s this will cause the larvae to suffocate.

10. Explain the patient information leaflet to the patient ensuring all questions are answered.

This helps patient understanding and reinforces informed consent.

11. Leave the patient a contact number if the patient is in the community.

To reassure the patient that someone can be contacted if needed.

12. Change outer padding daily. Stops maggots drowning and prevents strike through.

13. Following day of application Leave maggots on for up a further 4 days unless the patient asks for them to be removed.

The first day of application is counted as day ‘0’.

14. Reassess wound recording effect of larvae.

Ensures documented evidence of effect of treatment.

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APPENDIX 3

For BioBag Dressing ‘Bagged’ Maggots’

Equipment

BioBag dressing 60gm pot sudocrem (All included in Larvae pack) Community pack also contains bag for disposal Patient information leaflet 1 dressing pack Low adherent pad

Tape or bandage

Procedure for application Patient and medical consent must be obtained prior to treatment and Patient information given

Action Rational

1. Explain procedures to patient. Information reduces anxiety.

2. Wash hands, apply gloves and apron. To prevent cross infection.

3. Apply sudocrem to intact skin around the margin of the wound – thin layer.

Protects skin from exudate.

4. Remove the BioBag dressing containing the maggots from the transit container and place directly on the surface of the wound.

Enables the maggots to be access the wound tissue.

5. Repeat using as many BioBag dressings as necessary to cover the area to be cleansed.

To ensure best effect of larvae.

6. Complete the dressing with an absorbent pad held in place with tape or bandage as appropriate.

To keep larvae in place Do not use occlusive or film dressing s this will cause the larvae to suffocate.

7. Dispose of any unused Biobag dressings.

To follow clinical waste policies.

8. Dressing checked daily and move around the wound if required.

To move the larvae where they can be most effective on the wound.

9. Following day of application Leave maggots on for up a further 4 days unless the patient asks for them to be removed.

Dressing to be removed after 4 days. First day of application is day ‘0’

10. Record effects of maggots on the wound in the patient’s notes.

Written evaluation provides evidence of effects of treatment.

These larvae do not need watering

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APPENDIX 4

APPENDIX 4A

BioBag sizes and codes

Larvae free range calculator

Measure the dimensions of the wound in centimetres Pick the nearest size from the

measurements on the left of the chart

Move sideways to the appropriate percentage of wound coverage

State the number of larvae is indicated within the coloured cell.

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APPENDIX 5 Procedure for Removal of Free Range ‘Loose’ Maggots

Equipment Yellow clinical waste bag (larvae will be double yellow bagged) Saline Gauze toppers Forceps Dressing pack Solid plastic container if transporting maggots (as per clinical waste policy) CHECK WHEN CLINICAL WASTE IS COLLECTED!

Procedure

ACTION

RATIONALE

1. Explain procedures to patient. Information reduces anxiety.

2. Wash hands, apply gloves and apron. To prevent cross infection.

3. Ensure working area is protected. So maggots can be easily retrieved if they drop out of wound.

4. Loosen edges of dressing all the way around. Then scoop all the dressing into the middle removing as many of the maggots as possible.

Removal of maggots is made easier, if done this way.

5. Remove any remaining maggots with forceps or irrigate with sterile saline.

6. Dispose of dressing and maggot’s in yellow clinical waste bag. NB- If clinical waste is to be carried in a car, the plastic container (as specified in the clinical waste policy to be used). Contaminated Waste Policy must be followed

Ensures maggots are recognised as needing incinerating. Maggots must be incinerated within 3 days or frozen until incineration is possible.

7. Record effects of maggots on the wound in the patient’s notes.

Written evaluation provides evidence of effects of treatment.

8. Fill in the yellow evaluation form that came with the maggots and return as indicted on the form.

Ensures all treatments are evaluated cohesively and any adverse effects reported.

9. Redress the wound as appropriate, following wound care guidelines.

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APPENDIX 6

Procedure for Removal of BioBag Dressing ‘Bagged’ Maggots

Equipment Yellow clinical waste bag (larvae will be double yellow bagged) Saline Gauze toppers Wound dressing pack Solid plastic container if transporting maggots (as per clinical waste policy) CHECK WHEN CLINICAL WASTE IS COLLECTED!

Procedure

ACTION

RATIONAL

1. Explain procedures to patient. Information reduces anxiety.

2. Wash hands, apply gloves and apron. To prevent cross infection.

3. Ensure working area is protected. So maggots can be easily retrieved if dressing drops out of wound.

4. Loosen edges of dressing all the way around. Then lift all the dressings ready for disposal.

Removal of maggots is made easier, if done this way.

5. Dispose of dressing and maggot’s in yellow clinical waste bag.

6. NB- If clinical waste is to be carried in a car, the plastic container (as specified in the clinical waste policy).

Ensures maggots are recognised as needing incinerating. Maggots must be incinerated within 3 days or frozen until incineration is possible.

7. Record effects of maggots on the wound in the patient’s notes.

Written evaluation provides evidence of effects of treatment

8. Fill in the yellow evaluation form that came with the maggots and return as indicated on the form.

Ensures all treatments are evaluated cohesively and any adverse effects reported.

9. Redress the wound as appropriate following wound care guidelines.

On the death of a patient If a patient dies during maggot therapy, the maggots should be removed from the wound as soon as possible (prior to the transfer of the patient to the mortuary). Double bag maggots and dispose of in clinical waste.

This is to respect the dignity of the patient and the sensitivities of the family.

Orders can be placed b on 01656 668 047

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APPROVAL 9 APPROVAL Approving Committee:

Date of Approval:

Review Date:

NOTE: Should the SOP be a cross divisional document then approval must be sought from all affected divisions to ensure it is a valid and sufficient document. It is the responsibility of the lead division to ensure that this is completed and evidence of such is obtained.

Appendix 5