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TOPICAL HAEMOGLOBIN APPLICATION PROTOCOL INTRODUCTION Granulox®, launched in June 2012 as a Class III medical device in the EU, is a novel treatment that speeds healing in slow-healing/stalled or chronic wounds such as foot ulcers, leg ulcers, pressure sores and post-surgical wounds. The active ingredient is pure haemoglobin, which acts as an oxygen transporter from surrounding air to improve oxygen availability in the wound-bed and thus aid wound healing.

A wound that does not decrease in size by 30%-50% in 4 weeks is considered in general a chronic wound. (1 )

Chronic wounds commonly affect elderly and / or diabetic patients and are often caused by circulation problems or peripheral vascular disease that causes lower provision of oxygen to the wound via the blood (hypoxia).

Wound healing is supported by spraying a smal l amount of Granulox® onto the wound before application of standard (breathable) wound dressings. In a 13 week randomized controlled trial of slow healing leg ulcers, wounds were reduced in size by more than half when Granulox® was added to standard care, while patients on standard care alone had no significant improvement. Pain was also reduced, with 61% lower mean pain scores. A different 6-month study showed that more than 93% of patients with chronic lower leg and foot ulcers achieved wound healing within 6 months; this was often achieved for patients who had suffered their chronic wounds for months or years. (2) (3)

PRODUCT DESCRIPTION Granulox® is an aqueous solution used as an oxygen diffusion enhancer to deliver more oxygen to the wound bed cells to improve wound healing.

Oxygen deficiency is a predominant characteristic of many chronic wounds. Granulox® is an oxygen diffusion enhancer to deliver more oxygen to the wound bed cells to improve wound healing.

Major component of the medical device is a highly purified porcine hemoglobin fraction (100g/L) modified by carboxylation.

The Granulox® spray is applied as a thin layer to cleaned wound beds of chronic wounds once daily, or every second or third day. The product can easily be supplemented to already existing treatment regiments.

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GRANULOX® INDICATIONS Granulox® should be used for all slow-healing and non-healing wounds that have not responded to standard wound care as per the Wound Bed Preparation Guideline. (4)

Opt imiz ing the Moisture Management T ightrope with Wound Bed Preparat ion 2015 ©

Object ive : To provide an overview of moisture management and its importance in wound care. The authors evaluate the impact of moisture management for optimal wound care and assess current wound management strategies relating to antisepsis and moist wound healing utilizing the wound bed preparation paradigm 2015 update. The discussion distinguishes the form and function of wound care dressing classes available for optimal moisture management.

Conclus ion: Moisture management for chronic wounds is best achieved with modern moist interactive dressings if the wound has the ability to heal.” [Sibbard et al.]

TYPE OF WOUNDS: • Diabetic foot ulcers • Leg ulcers (Arterial/venous/mixed aetiology) • Decubitus/Pressure ulcers • Secondary healing of surgical wounds

PATIENT AND WOUND ASSESSMENT: It is recommended that the Wound Bed Preparation guideline be used as the primary assessment tool. All patients should be evaluated holistically by first determining the aetiology and factors influencing wound healing including the vascular status of the wound. This should be followed by addressing patient centered concerns such as pain and social economic circumstances. Once this information is available the Health Care practitioner needs to determine whether or not it is a healable, non-healable or maintenance wound. Wound bed assessment is done according to DIME.

D Debr idement of non-viable t issue

I S igns of loca l ized or systemic infect ion

M Moisture contro l

E Edge/epithel ia l advancement

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WOUND BED PREPARATION: Figure 1 : Adapted from Sibbard et a l [2015].

             

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   

 

CHRONIC WOUND PATIENT

DETERMINE HEALABILITY Healable, Maintenance, Nonhealable/Pal l iat ive

PATIENT-/FAMILY CENTERED

CONCERNS

IDENTIFY/ TREAT THE CAUSE

DEBRIDEMENT

LOCAL WOUND CARE

EDGE EFFECT MOISTURE  BALANCE

INFLAMMATORY/INFECTION

Co-morbid it ies Factors inf luencing heal ing:

- Vascular - Infection - Pressure

Pain Activities of daily living Psychological well-being Smoking Access to care, financial limitations

Healable Wound: Can be healed with adequate blood supply if the underlying cause is addressed

Maintenance Wound: Have healing potential,

compromised healing due to: patient non-adherence to treatment or health care

resources limitations

Nonhealable/Paliative Wound: Cannot heal due to: irreversible causes or

associated illnesses, including critical ischemia or

nontreatable malignancy

Nonhealable  wounds:

Conservative  D

Healable wounds: Active D

Treatment topical & systemic (antisepsis) I Balance M

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- Pain - Activities of daily living - Psychological well-being - Smoking - Access to care, financial limitations

Maintenance Wound: Have healing potential, compromised healing due to: patient non-adherence to treatment or health care resources limitations

Nonhealable/Pal iat ive Wound: Cannot heal due to: irreversible causes or associated illnesses, including critical ischemia or nontreatable malignancy

Nonhealable wounds: Conservative D

Reduction (antisepsis) I Reduction M

MOISTURE BALANCE

PATIENT-/FAMILY CENTERED CONCERNS

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IMPLEMENTATION IN WOUND CARE Once the underlying contributory factors is addressed and the appropriate measures have been taken to support wound healing (e.g. refer for vascular surgery/ compression therapy/ provide offloading) and the contributing factors (e.g. diabetes, cardiac disease, nutritional support) is under control Granulox® can be applied according to the application protocol.

The consensus recommendation is to apply Granulox® after 2-4 weeks of standard wound care to facilitate faster wound healing. It is also recommended to implement Granulox® earlier in the treatment program for patients at a high risk for delayed wound healing such as immunocompromised patients, diabetic patients and patients with vascular insufficiency.

Granulox® can be applied on all types of wounds as an adjunctive therapy together with standard wound care provided that the underlying causes are treated such as Vascular insufficiency, Infection and pressure. It is also important to maintain a moisture balance on the wound bed by using the appropriate dressing for the phase of wound healing. Figure 2 illustrates the importance of vascularisation, treatment of infection, pressure and moist wound healing. All of these can be contributing factors in delaying wound care resulting in a stalled or chronic wound. It is thus important to address these factors before applying Granulox® as adjunctive therapy.

Figure 3 illustrates the practical approach in applying topical haemoglobin to the wound bed. Please not that it is not recommended to use Granulox® in deep tissue infected wounds. The infection first needs to be identified and treated with antibiotics and a topical antimicrobial dressing. If superficial infection is identified Granulox® can be used in combination with a topical antimicrobial dressing (see table 2).

Recommended dress ings to be used for non-infected wounds or in combinat ion with ant imicrobia l in superf ic ia l infected wounds

Silicone foam dressings examples Mepilex Biatain silicone Allevyn gentle

Foam dressings examples Allevyn Biatain Hydrotac

Primary dressings examples Primapore Leukomed Opsite post op

Type of Ant imicrobia l Dress ing

Product Examples recommended for use with Granulox®

Iodine Inadine Hydrophobic Cutimed Sorbact Swab

Cutimed Siltec Sorbact foam dressing

Silver Acticoat Biatain Ag foam URGO Ag tulle Mepilex Ag Foam Allevyn Ag foam

Honey Actilite tulle Chlorhexidine Bactigras PHMB AMD Telfa

AMD foam

Figure 2 : Under ly ing causes for de layed wound heal ing

 

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GRANULOX® PRACTICAL TREATMENT PATHWAY: Figure 3: Chadwick et a l [2015] per Consensus Panel.  

 

 

 

 

 

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TIPS FOR USE: • Inform patients of the red appearance of the product in advance of use • Rinse the nozzle with warm water or saline d irect ly after use to prevent the nozzle from becoming

blocked I • Take appropriate action to avoid staining of clothes, using appropriate secondary dressing to prevent

strikethrough and leakage • Exudate levels should be managed pr ior to application of the product — high exudate levels may flush

the product out of the wound bed, with the potential to lose some of its beneficial oxygen giving properties

• Cleanse the wound at each dressing change to reassess the wound • Debride the wound as appropriate • Granulox should be stored in the fridge (4-8 Celsius) • The recommendation for optimal use of Granulox® was to reapply at every dressing change, with a

maximum wear time of 3 days .

TREATMENT MILESTONES: The consensus group recommended that informal reassessment of the wound occur at every visit, while formal review of treatment should occur every 4 weeks, as improvement is expected to occur within this timeframe (see treatment pathway in Figure 2). If there are signs of improvement, the treatment can be continued for a further 4 weeks. If no improvement is seen at 4 weeks, clinicians should consider alternative treatment options. Expected markers of healing would be: reduction in size of wound; improvements to appearance, wound bed, tissue, range of movement, exudate volume.

It is recommended to stick with 4-week review intervals where there are no adverse reactions. Clinicians should use their clinical judgement as to when to stop.

STEP BY STEP RECOMMENDED APPLICATION PROTOCOL:

STEP 1 – HOLISTIC WOUND ASSESSMENT Follow wound bed prep guide assessment of the wound Distinguish between infection and inflammation Follow flow diagram as recommended by consensus panel

 

     

STEP 2 – WOUND CLEANSING Clean the wound with low toxicity solution

o Saline o Prontosan o Anolyte/Hyperclorous acid

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STEP 3 – GRANULOX APPLICATION Remove protective cap. Hold spray head about 5 to 10 cm from the wound. Spray until the wound is uniformly coated with a thin layer (1 to 2 seconds is enough to cover a wound area of 2 × 3 cm). If necessary, clean the spray head afterwards with an alcohol swab

 

Note: Should spraying not be possible due to surface drying after non-use for a long period of time, the head can simply be removed and cleaned, or replaced using one of the x5 extra nozzles provided.    

STEP 4 – APPLY APPROPRIATE WOUND DRESSING Colonized or superficial infected wounds:

o Use antimicrobial dressings Non-infected wounds:

o Cover the wound with a breathable/permeable wound dressing.

STEP 5 – RE-EVALUATE Re-evaluate wound progress on a weekly basis to monitor progress Formal review of all wound treatment at 4 week intervals

 

GRANULOX® APPLICATION IN PRACTICE

         

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BIBLIOGRAPHY

1. Classifications for wound bed preparation and stimulation of chronic wounds. Falanga V. [2000] Wound Repair Regen, Vol. 8, pp. 347-352.

2. Pilot study: haemoglobin spray in the treatment of chronic diabetic foot ulcers. Chadwick , P . [2014] Wounds UK, Vol. 10, pp. 76-80.

3. Topical oxygen-haemoglobin use on sloughy wounds: positive patient outcomes and the promotion of self-care. Hunt, SD. [2015] Wounds UK, Vol. 11, pp. 90-95.

4. Optimising the Moisture Management Tightrope with Wound Bed Preparation [2015] Sibbald , RG, et a l . 10, s.l. : Wolters Kluwer Health, Inc, October 2015, Advances in skin & Wound Care, Vol. 28, pp. 466-476.

5. Clinical enquiries. Do topical antibiotics improve wound healing? Diehr , S , et a l . 2, [2007] Journal of Family Practice, Vol. 56, pp. 140-144.

6. Oxygen in wound healing and infection. Gottrup, F . [2004] Wound J Surg, Vol. 28, pp. 312-5.

7. Effect of air exposure and occlusion on experimental human skin wounds. Hinman CD, Maibach HI , . [1963] Nature, Vol. 200, p. 377.

8. Landis S . , Ryan S . , Woo K . , S ibbald R .G . , . Infections in chronic wounds. [book auth.] Rodeheaver G.T., Sibbald R.G., Krasner D.L. Chronic wound care: a clinical source book for healthcare professionals. 4th edition. Malvern : HMP Communications, [2007] pp. 299-321.

9. Wound healing essentials: let there be oxygen. Sen, CK. [2009] Wound Repair Regen, Vol. 17, pp. 1-18.

10. Special considerations in Wound Bed Preparation: An Update. [2011] Sibbald R .G . , Goodman L . , Woo K .Y . , Krasner D.L . , Smart H . , Tar iq G . , Ayel lo E .A . , Burre l R .R . , Keast D .H. , Mayer D . , Norton L . , Sa lc ido R.S . , . 9, s.l. : www.woundcarejournal.com, 2011, Advanced in Skin and Wound Care, Vol. 24, pp. 415-436.

11. Formation of the scab and the rate of epithelialization of superficial wounds in the skin of young domestic pigs. Winter GD. [1962] Nature, Vol. 193, pp. 293-294.

12. Wounds UK Best Practice statement. The use of topical antimicrobial agents in wound management. Wounds, UK. [ed.] Wounds UK. third edition, London : Wounds UK [2013].