NovoSorb BTMA unique synthetic biodegradable wound scaffold

Regenerating tissue. Changing lives.

NovoSorb BTM is a unique synthetic biodegradable wound scaffold that delivers good cosmetic and functional outcomes through regeneration of the dermis.

No Proteins. Biodegradable.NovoSorb BTM is a biodegradable tissue scaffold developed for the treatment of full-thickness wounds where the dermal structure has been lost to trauma or surgical debridement. Unlike other tissue scaffolds NovoSorb BTM does not contain any sensitizing proteins. It is designed to reduce shrinking, contraction of the wound and scar formation.

Comprising a wound-facing biodegradable foam (NovoSorb) bonded to a non-biodegradable transparent sealing membrane, the matrix can be implanted into surgically debrided wounds and is designed to deliver a more aesthetic outcome than that currently achieved by immediate split thickness skin grafting. This improved aesthetic is achieved as, over a short period of weeks, the dermis regenerates within the polyurethane foam matrix. This dermal regeneration reduces the ‘pie dish’ effect ,reduces the scar and improves functional outcomes.

Overview

Indications for useDeep Dermal Burns (not FDA approved for full thickness burns. PMA trials are in progress in the US)

Trauma and reconstructive surgery

Wide excision surgical wounds

Large wound closure

Scar Revision

Venous Leg Ulcers (VLU)

Diabetic related foot ulcers (DRFU)

Pressure injuries (PI)

The BTM Wound Dressing is composed of three layers

Foam A wound-facing, 2mm thick, white, open cell foam with a high degree of porosity (>90%) designed to subsequently biodegrade. The foam is a biocompatible, biodegradable polyurethane material.

Bonding layerA polyurethane adhesive layer which bonds the Foam and Sealing Membrane together.

Sealing MembraneA temporary, transparent polyurethane membrane designed to physiologically close the wound and limit evaporative water loss. The sealing membrane is designed to remain attached to the dermal foam, if required, for at least 30 days in vivo.

The BTM is designed to be surgically implanted into a fully debrided, clean, surgical wound. All necrotic and non-viable tissue must be removed before the BTM is implanted.

Ensure the edge of the BTM abuts the wound margin but does not overlap the surrounding skin. Staple or suture into place. The BTM should be tailored to fit the wound and body contours with a gentle tension to avoid pleats and wrinkles.

Full integration of the dermal layer into the BTM can be assessed by blanching the BTM area with your fingers. Once you have a rapid re-profusion of the area you have blanched the BTM can be delaminated.

When ready to delaminate remove the sutures/staples and lift a corner of the seal using a forcep. Maintain a 30 degree angle to the dermal area and peel the film away in a smooth motion.

Small to medium Wounds: can be closed through secondary intention using moist wound healing products to cover and protect the new dermis. Large surgical wounds or Burns: may require closure with split skin graft (SSG).

Composition

Implantation of BTM

1

2

3

4

Application in operating rooms

Customise the cut of the BTM to the contour of the area and ensure no overlap.

Note the contouring, firm fit to all areas including the axilla and joints.

Held in place with staples; note the contouring.

The areas over the trunk have been covered with an antimicrobial and elastic netting.

Whilst dressing protocols might be decided by the operating surgeon, it is recommended to cover the BTM with a low-adherent protective dressing, overdressed with an antibacterial dressing.

Compression may then be afforded with crepe bandages, and is important where swelling is likely. Splinting may be desirable if placement has been into a wound over a highly mobile area. This dressing should be changed every three days. Other dressing regimes may need to be changed more frequently depending on their duration of antibacterial action. The BTM Wound Dressing is synthetic but it has no intrinsic antibacterial properties. Splints can be discontinued at Day 7 post-placement.

Secondary dressing of the BTM

Application and rapid integration

Day 2 Day 4

Staged grafting

Day 9

Day 31

pt 5 Day 38post BTM

pt 1 Day 536

pt 1 Day 368

Outcomes

pt 1 Day 194 pt 1

Day 171 pt 1 Day 312

Necrotizing Fasciitis – Neck

Free flap application

Day 0Open

Current standard of care Non-BTMNote the scarring and the tendons in this example of the traditional approach.

BTM - Innovates the standardNote the lack of scar/contracture and topography.

Day 180

Note the full range of movement and lack of contraction.

Published use over bone

Various publications of BTM use can be found on our website and within the online peer review journal ePlasty. This particular case demonstrates the use of BTM over a calvaria (skull). This case study demonstrates the robust nature of BTM in a challenging clinical application.

Day 43

Day 40

Day 47

Day 89

Day 40 Day 11526 days post-grafting

Packaging

BTM comes sterilized in a multilayer packaging. A cardboard envelope contains a white aluminized peel-able pouch which encloses a sterile transparent peel-able pouch containing the BTM. Labels are affixed to the white aluminized pouch and the outer cardboard envelope, and carry details such as date of manufacture, product batch number and expiry date. Each pouch is nitrogen filled. Sterilisation: Gamma irradiation.

Catalogue number Description Pack sizes

PS-004-01 BTM Wound Dressing – 10cm x 10cm 1

PS-004-05 BTM Wound Dressing – 10cm x 10cm 5

PS-004-25 BTM Wound Dressing – 10cm x 10cm 25

PS-005-01 BTM Wound Dressing – 10cm x 20cm 1

PS-005-05 BTM Wound Dressing – 10cm x 20cm 5

PS-005-25 BTM Wound Dressing – 10cm x 20cm 25

PS-007-01 BTM Wound Dressing – 20cm x 40cm 1

PS-007-05 BTM Wound Dressing – 20cm x 40cm 5

PS-007-25 BTM Wound Dressing – 20cm x 40cm 25

Contraindications

BTM application is contraindicated in wounds where necrotic/devitalized tissue is present, such wounds must be surgically debrided to viable tissue pre-application. BTM should not be applied into overtly infected wounds, such wounds should be debrided of non-vital tissue and be topically treated with antimicrobial dressings +/- systemic antibiotics before application is considered. BTM should only be applied into surgically debrided chronic wounds where underlying pathology capable of potentiating the wound has been addressed

(e.g. meticulous blood sugar control in diabetic ulceration, compression hosiery/dressings in venous ulceration to combat sustained venous hypertension, etc). BTM should be applied into wounds only after effective hemostasis has been afforded.

Warnings

The following complications are possible with the use of wound dressings. If any of the following conditions occur, the device should be removed: chronic inflammation, allergic reaction, excessive redness, pain or swelling.

Precautions

BTM is sterile if the package is unopened and undamaged. Do not use if the package has been perforated or the seal is broken or any other contamination is suspected.

Opened and Unused BTM cannot be resterilized and must be discarded.

BTM should not be applied until excessive exudate, bleeding, acute swelling and infection are controlled.

Debridement or excision must be meticulous and remove any remaining necrotic tissue that may cause infection.

Application Site BTM size Surface area ~No: Sheets

Neck 10x20cm 200cm2 1–2

Anterior Trunk 20x40cm 800cm2 3–4

Posterior Trunk 20x40cm 800cm2 3–4

Buttocks 20x40cm 800cm2 2

Arms 10x20cm 20x40cm

200cm2 800cm2

A mix of sizes is advised to tailor to contours

Legs 10x20cm 20x40cm

200cm2 800cm2

A mix of sizes is advised to tailor to contours

Melanoma/wide excisions 10x10cm 100cm2 1–2

10x20cm 200cm2 1

DRFU 10x10 cm 100cm2 1

VLU 10x10 cm 100cm2 1

Estimate of pieces required

2/320 Lorimer StreetPort MelbourneVictoria Australia 3207

T +613 8681 4050F +613 8681 4099

polynovo.com.au