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Sterile Micronised Human Amnion Chorion and Polyhexamethylene Biguanide (PHMB) Powder for Advanced Wound Healing.

AmchoPlast FLO™

Name: AmchoPlast FLO™
SKU: Amchoplast FLO

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AmchoPlast Flo is a sterile micronized form of human amnion chorion powder impregnated with broad-spectrum, antimicrobial PolyHexaMethyleneBiguanide - PHMB (0.5% w/w). It is aseptically processed from donated human tissue and terminally sterilized by gamma irradiation.

As low as ₹550.00

About Product

AmchoPlast FLO^TM is a sterile micronised form of dehydrated human amnion chorion membrane with PHMB in a flowable powder form that can be either sprinkled onto irregular wound surfaces or reconstituted with normal saline to form a suspension that can be sprayed into cavity/tunneling wounds or undermined wound margins.

The micronisation process creates an ideal microenvironment and provides larger surface area for cell adhesion and growth.

Product Specification

Appearance:Off white to pale yellow micronised powder

Particle size: Not more than 500 microns

Moisture Content: Not more than 15%

Sterility: SAL value 10-6

Total Protein: 0.5% - 0.7% w/w

Composition: Each gram contains:
- Sterile dehydrated micronised human amnion chorion powder: 2% w/w
- PHMB: 0.5% w/w

Composition

AmchoPlast FLO^TM is a combination of:

Micronised Human Amnion-Chorion Membrane:Acts as a natural biocompatible scaffold and a biological barrier.

PHMB:PHMB is an ideal antimicrobial for dressings as it promotes healing and has no history of cytotoxicity and antimicrobial resistance. Reduces bacterial burden and inhibits the formation of biofilm by interacting with bacterial surfaces and breaking down the lipopolysaccharide (LPS) layer of the bacterial cell wall.

AGNES Proprietary Processing Technology

Donated placental tissues go through the steps of:

Donor Screening:Includes testing for the presence of infectious agents

Tissue Washing & Dehydration: Microbial and red cell contaminants removed and tissue is air dried

Soaking and Dehydration: The tissue is soaked in a dedicated amount of PHMB and dehydrated

Milling and Formulation: The tissue is subjected to micronisation. The powder is formulated with an excipient and filled in PP (Polypropylene) vials.

Sterilisation: Terminally sterilised using gamma irradiation

Packaging and Storage: Placed inside a carton box and stored in cool dry place

Available Quantity

AmchoPlast FLO^TM is available in the following formulations:

AmchoPlast FLO^TM - 1.5 g

AmchoPlast FLO^TM - 3 g

AmchoPlast FLO^TM - 6 g
Product Advantages

Derived from the human amnion chorion membrane, AmchoPlast FLO^TM acts as a barrier to prevent microbial penetration and growth within the dressing area. Here are some of its advantages:

Safety

Immunologically privileged due to very low levels of HLA antigens and no immune rejection, and therefore can safely be used as an allograft without requiring tissue matching between donor and patient

Terminal sterilisation provides additional safety by ensuring that the product is free from microbial contaminants

Rigorous donor screening and selection protocols that meet or exceed industry standards

Screens for infectious agents like:
- HIV-1/2 antibody & HIV antigen
- Hepatitis B surface antigen
- Hepatitis B core antibody
- Hepatitis C antibody
- Syphilis
- Malaria
- HTLV I & II antibody
- CMV IgG
- HIV-1 (NAT)
- HCV (NAT)

Storage and Shelf-life

Does not require refrigeration and can be stored in a clean and dry environment at ambient room temperature.

Under appropriate conditions, the product has a shelf-life of 18 months

Compatibility

Can be used along with other wound treatment protocols such as negative pressure wound therapy (NPWT) and hyperbaric oxygen therapy (HBO)

Can be placed under a sterile secondary dressing
Clinical Uses

AmchPlast FLO^TM has applications in the below mentioned types of wounds including:

Chronic Ulcers

Diabetic foot ulcers

Pressure ulcers

Venous ulcers

Arterial Ulcers

Surgical Reconstruction

Post-operative wounds

Surgical wounds

Soft tissue reconstruction

Donor sites

Traumatic wounds

First and second degree burns

Lacerations

Cuts

Abrasions

Acute Wounds

Moist wounds

Tunneled/undetermined wounds

Draining Wounds

Post-Operative Wounds

Partial/Full thickness wounds
Case Studies

Here are some of the case studies showcasing how AmchoPlast FLO^TM has helped in the management and recovery of various types of wounds.

Pressure Ulcer with Cavity Wound | 62-year-old Male

In 10 days the ulcer shrunk in size and epithelialization was achieved with accelerated wound healing.

Diabetic Foot Ulcer | 62-year-old Male

Chronic, non-healing diabetic foot ulcer healed at 10 weeks following 11 application of AmchoPlast FLO^TM

Cellulitis | 43-year-old Female

For a patient having Cellulitis necrotic tissue with Fasciotomy multiple wounds, the wound closure was achieved in 10 applications of AmchoPlast FLO^TM.

Tunnel Wound | 53-year-old Male Diabetic Patient

The wound on the right foot was closed after the 2nd application of AmchoPlast FLO^TM. The 3rd application was done to achieve Epithelialization.

52-year-old Male Diabetic Patient | Non-healing Ulcer

5 applications of AmchoPlast FLO^TM was used after every 48 hours and complete closure of the tunnelling wound was achieved.

Application Instructions

Preparation of Wound Site:

Flush the wound site liberally but gently with a sterile normal saline solution to remove the necrotic tissue.

Unpacking AmchoPlast FLO^TM:

Open the shrink wrap to retrieve the AmchoPlast FLO^TM vial.

Applying on Surface or Deep Wounds (dry form usage):

Remove the cap of the vial and sprinkle the particulate placental tissue over the wound.
Spread the product evenly with the help of a sterile surgical instrument.

Applying on Cavity/Tunnelling/Undermining Wounds:

AmchoPlast FLO^TM can be reconstituted with normal saline to form a suspension that can be sprayed into the wounds or undermined wound margins.

Dressing of the Wound:

Use a sterile non-adherent absorbent secondary dressing to cover the wound and secure with tape on either side of the dressing.

Changing the Sceondary Dressing:

Gently remove the non-adherent dressing.
If dressing is adhered to the wound, soak with saline solution until it loosens and then remove carefully.

AmchoPlast FLO^TM Re-application:

AmchoPlast FLO^TM can be applied every 48 hours until the wound heals.

Why choose LifeCell?

Processing Technology

Produced using LifeCell's proprietary AGNES processing technology, to provide an effective allograft with excellent handling characteristics.

Accreditations & Certifications

First Tissue Bank outside the US to be accredited with AATB for placental tissues, and licenced by NOTTO (National Organ and Tissue Transplantation Organization) Licensed by DCGI, and also accredited with agencies such as from CAP, NABL, ISO, WHO, & GMP

Quality Assurance

Designed and developed by strictly adhering to Good Manufacturing Practices (GMP) & Good Tissue Practices (GTP) protocols.

Prioritises Patient Safety

Terminally sterilised products to ensure patient safety.

Frequently
Asked Questions

Frequently Asked Questions

Wish To Know More?

Yes, it is ready-to-use.

No, one package should be used for one patient. It is only for single use.

No, AmchoPlast FLO^TM is derived from human placenta while other collagen products are derived from animal source. And AmchoPlast FLO^TM is far more superior in terms of efficacy as it not only contains
- Micronised Human Amnion-Chorion Membrane: Acts as a natural biocompatible scaffold and a biological barrier.
- PHMB: PHMB is used as an antimicrobial preservative to protect the wound dressing from bacterial penetration and colonization. PHMB reduces the microbial burden by inhibiting the formation of biofilm by interacting with bacterial surfaces and breaking down the lipopolysaccharide (LPS) layer of the bacterial cell wall.

18 months

AmchoPlast FLO^TM can be stored in a clean, dry environment at ambient room temperature. There is no need for refrigeration or freezing.