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Sterile Dehydrated Human Amnion Chorion Membrane Impregnated With Polyhexamethylene Biguanide (PHMB)

AmchoPlast PHMB

AmchoPlast PHMBTM is a sterile biological wound cover made from human amnion chorion membrane impregnated with 0.5% (w/w) broad-spectrum antimicrobial, PHMB. It has specialised pores to facilitate the free flow of exudate.

As low as ₹1,420.00

About Product

AmchoPlast PHMB^TM is intended for management of acute and chronic wounds:

- as it acts as a biological protective barrier by combining the effects of the native extracellular matrix (ECM) of the human amnion chorion membrane and a broad spectrum antimicrobial polyhexamethylene biguanide or PHMB.

- provides a protective barrier that supports the wound healing cascade & aids in the development of granulation tissue in acute and chronic closures

Product Specification

AmchoPlast PHMB^TM 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)

Composition

AmchoPlast PHMB^TM 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.

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

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

Sizes and Shapes

To ensure limited or no wastages and to facilitate free flow of exudate, AmchoPlast PHMB^TM 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
Product Advantages

Unlike artificial skin substitutes or dressings, the human amnion chorion membrane which natively plays the role of providing a protective barrier for the fetus in the womb, essentially plays the same function in wound care management, thus being an ideal wound cover. Added PHMB prevents 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.

Shelf-life of 2 years

Compatibility

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

Ease of Use

Ready to use and easy to handle

It does not easily fold into itself on application thereby offering enhanced barrier protection
Clinical Uses

AmchoPlast PHMB^TM is intended for use in acute or chronic, superficial or deep, infected or at-risk-of infection wounds, with light to moderate levels of exudate.

Here are a few examples:

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

Draining Wounds

Post-Operative Wounds

Partial/Full thickness wounds
Case Studies

Here are some of the case studies showcasing how AmchoPlast PHMB^TM, as a biological wound cover, has helped in the management and recovery of various types of wounds.

Diabetic Foot Ulcer | 62-year-old Male

Chronic, non-healing diabetic foot ulcer completely healed at almost 4 weeks following 8-10 applications of Amchoplast PHMB^TM.

Venous ulcer | 52-year-old Male

Non-healing venous ulcer healed after 9 applications of AmchoPlast PHMB^TM (dressing done every 3 days).

Chronic Venous ulcer | 49-year-old Male

Chronic non-healing venous ulcer healed after continuous application of AmchoPlast PHMB^TM.

Left Foot Gangrene | 60-year-old Male

Gangrene due to microbial infection healed after a month following 12 applications of Amchoplast PHMB^TM.

Application instructions

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 PHMB^TM allograft.

Unpacking AmchoPlast PHMB^TM:

Use sterile forceps to take out AmchoPlast PHMB^TM 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 PHMB^TM 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 PHMB^TM can be applied every 48 hours until the wound heals

Why choose LifeCell?

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

Frequently
Asked Questions

Frequently Asked Questions

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.

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)

Yes, AmchoPlast^TM 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 PHMB^TM can be stored in a clean, dry environment at ambient room temperature. There is no need to refrigerate or freeze.

No, AmchoPlast^TM does not contain any live cells.

Yes. Watch this video (insert video link) to learn more.

Yes, AmchoPlast PHMB^TM 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, AmchoPlast^TM 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 PHMB^TM 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, AmchoPlast^TM 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.