AmchoPlast PHMBTM is a dry, thick human amnion-chorion membrane impregnated with broad-spectrum antimicrobial PHMB. It is both semi-permeable and bioabsorbable:
Layers:Amnion and Chorion layers (add image depicting all the layers)
Coating:Polyhexamethylene Biguanide (PHMB)
Transperency:Clear membrane (>70% clarity)
Thickness: Not less than 60 microns
Tensile strength:Not less than 0.25 N
Sterility: SAL value 10-6
Moisture Content: Not more than 15%
Total protein: Not less than 200 μg/cm^2
Embossing: “LC” as a guide to support correct placement on the wound
Pore size: 0.5 mm pores with 1 cm gap (Add image)
AmchoPlast PHMBTM is a combination of:
Extracellular matrix (ECM) of the 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.
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
Cutting & Packaging: Tissues of the right size and pores are cut using lasers and placed inside multiple poly-foil peel pouches and then in an outer carton
Sterilization: Terminally sterilized using gamma irradiation
To ensure limited or no wastages and to facilitate free flow of exudate, AmchoPlast PHMBTM is available in different shapes (Square or rectangle) and sizes.
12 cm x 6 cm
8 cm x 6 cm
5 cm x 5 cm
3 cm x 3 cm
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.
Shelf-life of 2 years
Used along with other wound care management protocols such as negative pressure wound therapy (NPWT) and hyperbaric oxygen therapy (HBO)
Can be placed under a sterile secondary dressing
Ready to use and easy to handle
It does not easily fold into itself on application thereby offering enhanced barrier protection
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
Draining Wounds
Post-Operative Wounds
Partial/Full thickness wounds
Chronic, non-healing diabetic foot ulcer completely healed at almost 4 weeks following 8-10 applications of Amchoplast PHMBTM.
Non-healing venous ulcer healed after 9 applications of AmchoPlast PHMBTM (dressing done every 3 days).
Chronic non-healing venous ulcer healed after continuous application of AmchoPlast PHMBTM.
Gangrene due to microbial infection healed after a month following 12 applications of Amchoplast PHMBTM.
Wound bed preparation:
Clean the wound with normal saline solution and perform sharp debridement with a sterile instrument (if slough is present).
Choosing the right size:
Measure the wound and choose appropriately sized AmchoPlast PHMBTM allograft.
Unpacking AmchoPlast PHMBTM:
Use sterile forceps to take out AmchoPlast PHMBTM from the inner foil pouch to avoid contamination.
Ensuring proper orientation:
To ensure appropriate orientation, check whether the embossed letters “LC” are displayed correctly when read from left to right.
Applying the membrane and hydration:
Apply AmchoPlast PHMBTM on the wound gently with sterile forceps and spread out the membrane to maximise the contact with the wound bed. Add a few drops of normal saline to hydrate the membrane.
External wound dressing:
A sterile non-adherent absorbent secondary dressing must be placed on top of the allograft to control bleeding and prevent contamination and secured with a bandage.
Allograft Re-application:
AmchoPlast PHMBTM can be applied every 48 hours until the wound heals
Proprietary Technology
Produced using LifeCell’s proprietary AGNES processing technology, to provide an effective allograft with excellent handling characteristics
Licenced & Accredited:
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
Wish To Know More?
Any wound that fails to respond to treatment even after four weeks or remains unhealed entirely in two months is regarded as a chronic wound. A chronic wound is often found to be complicated because of underlying conditions like diabetes, circulation problems etc. due to the interruption of the body’s natural healing process. Some of the common chronic wound conditions include diabetic foot ulcers, venous ulcers, surgical site injuries, burn injuries and pressure ulcers.
No. Prior to donation, the donor’s medical and social history are screened for medical conditions or diseases that would contraindicate the donation of tissues in accordance with current policies and procedures approved by LifeCell.
Donor blood samples taken at the time of collection are tested negative/non -reactive for relevant communicable and infectious disease agents at LifeCell International, which has requisite national and/or international accreditations.
Yes, AmchoPlastTM is a ready-to-use product.
No, it is for single use only.
Yes. The allograft can be cut/trimmed as per the wound requirement and must be immediately applied onto the wound bed once it is taken out from the inner foil pouch since it being a sterile product it can get easily contaminated if exposed.
AmchoPlast PHMBTM can be stored in a clean, dry environment at ambient room temperature. There is no need to refrigerate or freeze.
No, AmchoPlastTM does not contain any live cells.
Yes. Watch this video (insert video link) to learn more.
Yes, AmchoPlast PHMBTM can also be used as an adjunct with other wound care therapies including negative pressure wound therapy (NPWT) and hyperbaric oxygen therapy (HBO).
Yes, It can be placed under an external dressing.
Yes, AmchoPlastTM can be used for both chronic and acute wounds.
It has a shelf-life of 2 years.
Depending on the severity of the wound and prescribed treatment, the number of applications may vary. AmchoPlast PHMBTM can be applied on a biweekly basis until the wound heals (Dressing to be changed every 48 hours).
Proprietary processing and validated sterilisation methods are employed to eliminate potential deleterious components of the allograft. It is a well known fact that the amniotic membrane is non-immunogenic in nature.
In addition, AmchoPlastTM should be used with caution in patients with a known intolerance towards Ofloxacin, Vancomycin, and Amphotericin B antibiotics.
Yes, our product can be used at home under clinician’s directed supervision.
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