Clinical education

Bioprotein in Advanced Wound Management

From patient selection to clinical application, documentation and follow-up.

Trusted Care. Inspired Innovation.

2–3 hours Clinical competency

Core message

Advanced therapy works best when the basics are excellent.

Assess the patient. Treat the cause. Prepare the wound. Apply only when indicated. Measure objectively.

Assess

→

Prepare

→

Apply

→

Review

Section 00

How to run this workshop

Recommended format: a 2.5-hour master class that can expand to 3 hours or compress to 2 hours.

0–10

Opening + pre-test

Baseline knowledge and clinical framing.

10–55

Wound science + assessment

Why wounds fail and how to assess safely.

55–95

Wound-bed preparation + bioprotein science

TIME, aetiology-specific care and product positioning.

95–105

Break

Reset before practical modules.

105–150

Selection + demonstration + hands-on

Algorithm, simulated application and competency checklist.

Trainer setup

Projector and internet-free deck backup
Wound photos or printed case cards
Simulated wound model
Demo vial/syringe/saline/needle pack
Procedure checklist and documentation form
Latest manufacturer IFU / Klinik SOP

Section 00

Learning outcomes

Clinical judgement

Identify wound aetiology, red flags and suitability for adjunctive therapy.

Practical technique

Prepare the wound, reconstitute product safely and demonstrate simulated application.

Governance

Document objectively, follow up consistently and know when to escalate.

By the end, doctors should know when to use bioprotein — and just as importantly, when not to use it.

Opening activity

Pre-test discussion

Ask the room

What is the commonest reason a chronic wound fails to heal?
Which wound should not receive advanced adjunctive therapy today?
How do you measure treatment response objectively?

Trainer prompt

Capture answers without correcting immediately. Return to these questions during the final recap.

Suggested tool: Mentimeter, show of hands, or printed MCQ sheet.

01 — Why wounds fail to heal

A chronic wound is usually a symptom of an unresolved problem.

The wound surface is where we see the failure. The cause may be pressure, ischaemia, venous hypertension, infection, diabetes, nutrition, repeated trauma — or several of these at once.

Teaching principle: do not start with “which dressing?” Start with “why is this wound still open?”

Normal wound healing: four overlapping phases

Hemostasis

Clot formation, platelet activation and early signalling.

Inflammation

Cell recruitment, bacterial control and debris clearance.

Proliferation

Granulation, angiogenesis, collagen deposition and epithelial movement.

Remodelling

Matrix maturation, tensile strength and scar evolution.

The chronic wound loop

Underlying cause

→

Inflammation

→

Tissue breakdown

→

Bioburden / exudate

→

Edge fails to advance

Adding an advanced product without breaking this loop may produce poor results and poor clinical confidence.

Factors delaying healing

Local barriers

Necrotic tissue / slough
High bioburden or infection
Pressure and shear
Foreign body
Excess exudate or desiccation
Undermining / dead space
Repeated trauma

Patient/system barriers

Diabetes and hyperglycaemia
Peripheral arterial disease
Venous hypertension/oedema
Malnutrition or anaemia
Smoking
Renal disease / frailty
Immunosuppression

Clinical rule: treat the cause first

Weak approach

“This wound is chronic. Let’s apply the advanced product.”

Strong approach

“What is the wound aetiology, what is delaying healing, and is the wound ready for adjunctive therapy?”

The product is not the plan. The plan is the plan.

02 — Structured wound assessment

Assess the patient before you assess the wound.

A beautiful dressing on the wrong diagnosis is still the wrong treatment.

Start with the whole patient

A clinician examining a patient's right foot during a diabetes assessment. — Photo: CDC / Amanda Mills · Public domain

1. Assess the patient

Do not let the wound distract you from the person attached to it.

2. Find the barrier

Every chronic wound has one or more reasons for delayed healing.

3. Correct what you can

Product use makes more sense after pressure, perfusion, infection and systemic issues are reviewed.

Before considering bioprotein, ask: “What must be corrected for this wound to heal?”

Lower-limb anatomy & bedside checks

A clinician palpating dorsalis pedis pulses on the tops of both feet. — **Dorsalis pedis**Dorsum of foot

A clinician palpating posterior tibial pulses behind both medial malleoli. — **Posterior tibial**Behind medial malleolus

Photos: opennursing · CC BY · Source & attribution

Look deeper than the skin

Ask whether tendon, fascia, bone or joint may be involved — and whether the wound anatomy has changed over time.

Always check circulation

Palpate pulses, compare temperature, inspect colour and capillary refill, then escalate to Doppler/vascular review when needed.

Match wound zone to likely cause

Plantar callused wounds suggest pressure/neuropathy; toe/lateral-foot wounds raise concern for ischaemia.

This anatomy slide helps doctors visualise common wound zones and pulse landmarks before moving into aetiology and vascular safety. Common arterial-ulcer zones: toes, lateral foot and pressure points with poor perfusion. Common pressure / DFU zones: heel, plantar forefoot, bony prominences and callused sites. Dorsalis pedis pulse: dorsum of foot. Posterior tibial pulse: behind medial malleolus. Photos: opennursing, Palpation of Dorsalis Pedis and Posterior Tibial Pulses – Peripheral Vascular System Chapter, Creative Commons Attribution. Original video: https://www.youtube.com/watch?v=zly846Ncsd8 . Stills hosted by Toronto Metropolitan University; image-specific CC BY attribution is documented in Nursing Physical Assessment, College of DuPage, Figure 12.14. These are examination demonstrations, not wound-treatment outcomes.

Identify wound aetiology

Wound type	Clues	Do not miss
Diabetic foot ulcer	Neuropathy, callus, plantar pressure, deformity	PAD, infection, osteomyelitis, offloading failure
Venous leg ulcer	Gaiter area, oedema, pigmentation, exudate	Compression safety and arterial assessment
Arterial ulcer	Pain, punched-out lesion, cool limb, weak pulses	Urgent vascular referral if limb threat
Pressure injury	Bony prominence, immobility, shear/friction	Pressure redistribution and nutrition
Post-op / trauma	Dehiscence, tissue injury, foreign body risk	Infection, dead space, surgical review

Use a repeatable wound assessment language

S — Size

Length × width × depth. Note undermining and tunnelling.

T — Tissue

Granulation, slough, necrosis, exposed structures.

I — Infection

Local signs, spreading signs, systemic features.

M/E/P

Moisture, edge and periwound condition.

Suggested clinic standard: same measurement method, same camera position, same follow-up interval where possible.

Infection: clinical judgement first

Look for

Increasing pain
Erythema, warmth, swelling
Purulent discharge
Friable tissue / malodour
Delayed healing with inflammation
Fever or systemic symptoms

Then decide

Local wound care only?
Culture when clinically indicated?
Antibiotics?
Imaging for osteomyelitis?
Drainage/debridement?
Referral?

Reference anchor: IWGDF/IDSA diabetic foot infection guidance emphasises diagnosis and management of infection as a dedicated pathway.

Vascular status: the safety gate

Red flags — stop and rethink

Rest pain or pain out of proportion
Cold foot, pale/blue toes, delayed capillary refill
Gangrene / black toe / tissue necrosis
Absent or markedly reduced pedal pulses
Rapid deterioration or infected ischaemic wound
Systemic upset with a threatened limb

Do not let an advanced product delay vascular escalation.

ABI may be unreliable in diabetes because of calcified vessels. If available, toe pressure/TBI can be helpful, especially when the clinical picture and ABI do not match.

Documentation baseline

Parameter	Minimum standard	Why it matters
Size	Length × width × depth in cm	Allows objective response tracking
Tissue	% granulation, slough, necrosis	Shows wound-bed trajectory
Exudate	Low / moderate / heavy	Guides dressing choice
Edge/periwound	Maceration, callus, undermining	Identifies barriers
Photo	Consent + consistent angle/distance	Clinical review and audit

03 — Wound-bed preparation

Prepare the wound before applying advanced therapy.

Bioprotein should be considered only after basic barriers are assessed and managed: non-viable tissue, infection/inflammation, moisture imbalance and non-advancing edges.

TIME framework

T — Tissue

Remove or reduce non-viable tissue so the wound bed can be assessed and treated accurately.

I — Infection / inflammation

Control bacterial burden and inflammatory drivers before expecting a biological adjunct to perform well.

M — Moisture

Choose dressings that absorb when needed, but avoid desiccation or periwound maceration.

E — Edge

If the edge is not advancing, revisit aetiology, pressure, perfusion, infection and patient factors.

TIME is a systematic wound-bed preparation approach described in wound-care literature.

Debridement: purpose and caution

Why debride?

Remove necrotic burden
Reduce slough and debris
Expose viable wound bed
Enable accurate assessment
Improve dressing contact

Pause first when

Dry stable ischaemic eschar
Critical limb ischaemia suspected
Uncontrolled bleeding risk
Severe pain out of proportion
Need surgical/vascular input

Dressing choice: match the wound need

Wound feature	Dressing direction	Avoid
Heavy exudate	Absorptive secondary dressing	Occlusion that worsens maceration
Dry wound bed	Moisture donation/retention	Further drying
Fragile periwound	Skin protection and atraumatic fixation	Repeated adhesive trauma
Dead space	Appropriate packing without overpacking	Superficial cover only
Pressure-related	Pressure redistribution/offloading	Dressing-only strategy

Aetiology-specific essentials

DFU

Offloading, callus care, infection assessment, vascular assessment and glycaemic optimisation.

VLU

Compression pathway after arterial assessment, oedema control and skin care.

Arterial

Perfusion assessment and vascular referral; avoid delaying limb-salvage decisions.

Advanced therapy is layered on top of aetiology-specific care — not substituted for it.

04 — Bioprotein science & Cellmax™ positioning

Bioprotein is best taught as a biological signal support — not a miracle wound closure promise.

The scientific story should be mechanistic, cautious and clinically governed.

What do we mean by “bioprotein”?

Concept

A cell-free mixture of bioactive signalling molecules intended to support tissue-repair processes.

Language to use

Secretome, cytokines, chemokines, growth factors, angiogenic signalling, fibroblast activity and epithelialisation.

Avoid overclaiming. Mechanistic plausibility does not guarantee an individual clinical result.

Proposed biological roles in wound repair

How to explain it

Bioprotein is best framed as biological signal support that may improve the wound-healing environment.

What not to say

Avoid teaching it as a guaranteed wound-closure shortcut or a replacement for wound fundamentals.

Teach the mechanism as “supporting the healing environment”, not “forcing the wound to heal”.

Cellmax™ regulatory anchor

MDA

Cellmax™ Freeze Dried Powder

MDA Registration No: GD8996426-239437

Clinical framing: healthcare-professional use as an adjunct to standard wound care for selected adult chronic/non-healing wounds within the registered intended purpose.

Training implication: use current MDA registration, latest IFU and Klinik Inocare SOP as controlling references.

What Cellmax™ is not

Not first-line alone

It does not replace wound-bed preparation, offloading, compression, antibiotics when indicated or vascular care.

Not for every wound

Patient selection matters. Some wounds need urgent referral or cause correction first.

Not a guarantee

Response must be monitored objectively. Non-response requires reassessment.

Product-specific IFU caution

Do not invent dosing, injection-point count or volume-per-area during training. These must come from the current manufacturer IFU / approved Klinik SOP.

From public manufacturer material

Published Cellmax information describes reconstitution of a freeze-dried 2 mL vial with 2 mL sodium chloride and subcutaneous application by trained medical personnel.

For final live training

Insert the latest authorised table for wound area, application volume and injection distribution from the current IFU.

05 — Patient selection

The best outcome starts with the right wound, at the right time, in the right patient.

A simple algorithm helps doctors decide whether to proceed, optimise first or refer.

Selection algorithm

Start

Chronic / non-healing wound

→

Step 1

Identify wound aetiology

→

Urgent red flags?

Yes

→

Do not proceed routinely

Treat, stabilise or refer first

→

Step 2

Prepare wound bed (TIME)

→

Cause addressed well enough?

→

Step 3

Check IFU indication + consent

→

Proceed

Apply + document + review

If any safety gate fails, do not proceed as routine. Optimise, treat or refer first.

Proceed only when the basics are addressed

Favourable profile

Chronic/non-healing wound within intended use
Cause identified
No uncontrolled infection
Perfusion acceptable or assessed
Pressure/oedema addressed
Wound bed prepared
Follow-up feasible

Delay or refer

Critical ischaemia/gangrene
Spreading infection/sepsis
Suspected deep abscess
Possible osteomyelitis needing workup
Uncorrected pressure/offloading failure
Unclear diagnosis or atypical wound

Consent conversation

Suggested explanation to patient

“This treatment is an additional therapy used together with standard wound care. We still need to control infection, pressure, blood flow, sugar level and dressing care. We will measure and photograph the wound so we can see whether it is responding.”

Explain

Purpose, steps, expected review schedule.

Disclose

Uncertainty, alternatives, cost, possible discomfort/risks.

Document

Consent, wound baseline, product batch and plan.

06 — Practical application workflow

Standardise the procedure from room setup to follow-up.

Variation in preparation, application and documentation makes outcomes difficult to interpret.

Procedure room setup

Aseptic field

Clean trolley, PPE, sterile consumables, sharps container and waste disposal.

Wound kit

Normal saline, gauze, debridement tools if appropriate, ruler, camera, dressing set.

Product kit

Cellmax vial, sodium chloride for reconstitution, syringe/needle, batch documentation.

Step 1: confirm before opening product

Patient check

Identity
Consent
Allergy/precaution review
Indication confirmed
Red flags excluded

Product check

Correct product
Package integrity
Expiry date
Storage condition
Batch/lot number recorded

Step 2: prepare the wound

Remove dressing

→

Cleanse

→

Assess

→

Debride if appropriate

→

Re-measure + photo

Do not proceed blindly. The wound may have changed since the last review.

Step 3: reconstitute according to IFU

Teaching sequence

Maintain aseptic technique.
Reconstitute using the authorised diluent/volume.
Inspect solution before use.
Use within the IFU/SOP-defined conditions.

Current public note

Public Cellmax material describes a freeze-dried 2 mL vial mixed with 2 mL sodium chloride, producing a clear liquid without sediment.

Step 4: application planning

Map the wound first

Identify the true wound edge, wound base, fragile structures, pain-sensitive areas and any undermining before planning application.

Use the authorised table

Application volume, spacing and number of points must follow the latest IFU / Klinik SOP.

Think beyond the product

After application, your dressing strategy and cause-specific care still determine what happens over the next days and weeks.

Public Cellmax material describes subcutaneous application at/near the wound edge and wound base/floor by trained medical personnel. Use the latest IFU for the live procedural demonstration.

Step 5: secondary dressing

Protect

Protect the treated wound bed and fragile periwound.

Balance

Choose dressing based on exudate, depth and tissue type.

Support cause care

Continue offloading, compression pathway or pressure redistribution where indicated.

Application is one procedural moment. Healing depends on everything that happens afterwards.

Post-procedure orders & follow-up

Area	Document / instruct	Example
Procedure	Product, batch, reconstitution, application sites, dressing	Use clinic procedure template
Patient advice	Warning signs and dressing care	Pain, fever, spreading redness, leakage
Cause control	Offloading/compression/glucose/nutrition	Specific written plan
Review	Date and objective reassessment	Photo + measurement at each review

07 — Case-based practice

Cases convert product knowledge into clinical judgement.

Ask doctors to decide: proceed, optimise first, or refer.

Case 1

Case 1 — Plantar diabetic foot ulcer

Patient: 55-year-old man, diabetes, HbA1c 9.2%, plantar forefoot ulcer for 8 weeks.

Wound: callus edge, moderate exudate, reduced sensation, no fever, no spreading cellulitis.

Clinic issue: patient asks for the “new wound injection” today.

Would you apply bioprotein today?

Insert real DFU photo here later

Suggested image: plantar wound photo ± offloading footwear photo.
Optional second image: pedal pulses / Doppler / X-ray.

Case 1 answer

Case 1 — teaching answer

Possible, but not automatically. First confirm perfusion, manage callus/wound bed, ensure offloading and address glycaemic/systemic barriers.

Must do

Offloading plan and debridement/callus management.

Must check

Infection and PAD screen.

Then consider

Adjunctive bioprotein if wound is suitable and follow-up is reliable.

Case 2

Case 2 — Venous leg ulcer

Patient: 68-year-old woman with medial gaiter ulcer for 6 months.

Wound: heavy exudate, oedema, haemosiderin pigmentation, irregular shallow ulcer.

Clinic issue: recurrent dressings but no clear compression pathway.

Is bioprotein the first intervention?

Insert real VLU photo here later

Suggested image: medial gaiter ulcer with oedema.
Optional second image: compression bandage system or venous skin changes.

Case 3

Case 3 — The dangerous diabetic foot

Patient: 62-year-old diabetic, increasing foot pain and black toe.

Wound: cool foot, weak/absent pulse, surrounding cellulitis, malodour.

Clinic issue: family requests advanced wound therapy to avoid hospital referral.

Cellmax or urgent referral?

Insert real limb-threat case photo here later

Suggested image: gangrenous toe / ischaemic foot.
Optional second image: Doppler result or referral pathway visual.

Case 3 answer

Case 3 — teaching answer

Do not proceed as routine. This is a limb-threatening scenario until proven otherwise.

Recognise threat

→

Stabilise / initial care

→

Urgent referral

→

Reassess later

08 — Competency & governance

A training programme is only useful if it changes practice reliably.

Use a short checklist, post-test and observed practical station.

Observed competency checklist

Domain	Pass criteria	Trainer sign-off
Assessment	Aetiology, infection, vascular status and red flags assessed	☐
Selection	Indication, contraindications/precautions and consent checked	☐
Preparation	Aseptic setup, wound-bed preparation and product check completed	☐
Application	Simulated application follows IFU/SOP workflow	☐
Follow-up	Objective documentation and review plan completed	☐

Post-test questions

Knowledge

Name four barriers to chronic wound healing.
What does TIME stand for?
Name three red flags requiring referral.
Why is offloading essential in DFU?
Why should response be measured objectively?

Application

When should bioprotein be delayed?
What must be checked before opening product?
What information must be documented?
How do you counsel about expected outcomes?
What do you do if the wound deteriorates?

Clinic documentation minimum set

Baseline

Diagnosis, aetiology, size, tissue, infection status, vascular screen, photo consent.

Procedure

Product, batch, expiry, reconstitution, application details, dressing and immediate tolerance.

Review

Serial measurements, photos, complications, adherence, next plan and escalation decision.

Good documentation makes outcome review possible — clinically, operationally and medico-legally.

When the wound is not improving

Do not simply repeat the same intervention. Reassess the diagnosis and the barriers.

Ask: infection? ischaemia? pressure? venous oedema? osteomyelitis? nutrition? glucose? adherence? atypical wound?

Escalate when

Deterioration
New necrosis
Spreading infection
Pain out of proportion
No meaningful progress
Diagnostic uncertainty

Closing

Five take-home messages

1

Diagnose the wound cause.

2

Prepare the wound bed.

3

Select the right patient.

4

Apply according to IFU/SOP.

5

Measure and reassess.

Advanced wound therapy should be clinically disciplined, not product driven.

Appendix

Optional: 2-hour compressed agenda

Time	Content	Method
0–10	Opening + objectives + pre-test	Interactive
10–35	Wound healing failure + assessment	Lecture
35–60	Wound-bed preparation + red flags	Lecture/cases
60–80	Bioprotein science + Cellmax positioning	Lecture
80–105	Patient selection + practical workflow	Algorithm/demo
105–120	Case challenge + post-test	Discussion

Appendix

Case-photo insertion guide

Recommended image set per case

1 overview wound photo
1 close-up wound photo with scale/ruler
1 supporting image if relevant: offloading device, compression, X-ray, Doppler or follow-up photo
Consent and de-identification confirmed

Layout tip for Reveal.js

Keep one hero image large, and place supporting images as small thumbnails. Use the same crop ratio across cases so the deck looks consistent.

Because the current deck uses placeholder blocks, you can swap each placeholder with a local img tag later without redesigning the slide.

Appendix

GitHub Pages presenter tips

Keyboard

F fullscreen S speaker notes Esc overview B black screen

M menu T chalkboard C draw on slide

Use the bottom-left Menu button for tools, slide search and all shortcuts.

Print to PDF

Add ?print-pdf to the URL, then use the browser print dialog.

References

Core references used to prepare this deck

Malaysia Medical Device Authority, Malaysia Medical Device Register — Cellmax™ Freeze Dried Powder entry and public register search. https://mdar.mda.gov.my/
Cellmax™ official product information: “What is Cellmax” and preparation/application notes. https://cellmax.com.my/what-is-cellmax/
International Working Group on the Diabetic Foot. IWGDF Guidelines 2023 update. https://iwgdfguidelines.org/guidelines-2023/
IWGDF/IDSA Guidelines on the diagnosis and treatment of diabetes-related foot infections, 2023 update. https://www.idsociety.org/practice-guideline/diabetic-foot-infections/
Harries RL et al. Wound bed preparation: TIME for an update. International Wound Journal. 2016. https://pmc.ncbi.nlm.nih.gov/articles/PMC7949772/
Sibbald RG et al. Best Practice Recommendations for Preparing the Wound Bed: Update 2006. Wound Care Canada. https://www.woundscanada.ca/

Final clinical-use version should be checked against the latest manufacturer IFU, authorised training manual and Klinik Inocare SOP before delivery.

Trusted Care. Inspired Innovation.

Thank you

Safe selection. Careful application. Objective follow-up.

Doctor Training Workshop | Bioprotein in Advanced Wound Management