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
AmchoPlast FLOTM 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.
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
AmchoPlast FLOTM is available in the following formulations:
AmchoPlast FLOTM - 1.5 g
AmchoPlast FLOTM - 3 g
AmchoPlast FLOTM - 6 g
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)
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
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
Diabetic foot ulcers
Pressure ulcers
Venous ulcers
Arterial Ulcers
Post-operative wounds
Surgical wounds
Soft tissue reconstruction
Donor sites
First and second degree burns
Lacerations
Cuts
Abrasions
Moist wounds
Tunneled/undetermined wounds
Draining Wounds
Post-Operative Wounds
Partial/Full thickness wounds
In 10 days the ulcer shrunk in size and epithelialization was achieved with accelerated wound healing.
Chronic, non-healing diabetic foot ulcer healed at 10 weeks following 11 application of AmchoPlast FLOTM
For a patient having Cellulitis necrotic tissue with Fasciotomy multiple wounds, the wound closure was achieved in 10 applications of AmchoPlast FLOTM.
The wound on the right foot was closed after the 2nd application of AmchoPlast FLOTM. The 3rd application was done to achieve Epithelialization.
5 applications of AmchoPlast FLOTM was used after every 48 hours and complete closure of the tunnelling wound was achieved.
Preparation of Wound Site:
Flush the wound site liberally but gently with a sterile normal saline solution to remove the necrotic tissue.
Unpacking AmchoPlast FLOTM:
Open the shrink wrap to retrieve the AmchoPlast FLOTM vial.
Applying on Surface or Deep Wounds (dry form usage):
Applying on Cavity/Tunnelling/Undermining Wounds:
AmchoPlast FLOTM 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:
AmchoPlast FLOTM Re-application:
AmchoPlast FLOTM can be applied every 48 hours until the wound heals.
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.
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 FLOTM is derived from human placenta while other collagen products are derived from animal source. And AmchoPlast FLOTM 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 FLOTM can be stored in a clean, dry environment at ambient room temperature. There is no need for refrigeration or freezing.
AmchoPlast FLOTM can be:
No, it is non-immunogenic.
Yes, it is bioabsorbable.
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