patient information guide - larval information guide ... what is larval therapy? larval therapy...
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Caution: Federal law restricts the sale of this product to, or on the order of a licensed clinician.
Patient Information Guide
How does BioBag work?
Larvae do not have teeth so they do not bite or chew, instead they
produce liquid secretions which pass through small holes in the
polyester BioBag dressing onto the wound. The secretions break down
the devitalized tissue and bacteria into a liquid which they ingest as
nutrition. They are able to complete this process very effectively while
being completely contained within the BioBag.
What is BioBag used for?
The FDA cleared, prescription only medical device BioBag is indicated
for the debridement (cleaning) of necrotic skin and soft tissue
wounds such as pressure ulcers, diabetic ulcers, venous stasis ulcers,
surgical wounds and traumatic wounds. Debridement is the removal
of unviable tissue and bacteria from a wound to allow progression
through the wound healing process.
Thank you for considering BioBag as a
wound debridement option.
We understand that you may have a lot of
questions, let us answer them for you.
What is Larval Therapy?
Larval Therapy (also known as Maggot Therapy or Biosurgery) is a
natural form of wound debridement (cleaning) using the living larvae
of the greenbottle fly species called Lucilia sericata. The larvae of
the greenbottle fly are safe to use and the treatment has a long and
successful history. BioMonde has a unique approach to Larval Therapy
and packages the larvae within a sealed dressing called BioBag.
Where do the larvae come from?
BioMonde have been producing larvae for wound care since 1994.
BioMonde have a specialist facility in Gainesville, Florida which houses
the greenbottle fly Lucilia sericata. The life cycle is nurtured to allow the
creation of the fly larvae which are produced using an aseptic process
which means that they are free from contamination. BioMonde are
dedicated to your safety and work to strict quality standards.
Why should I use Larval Therapy?
The benefits of Larval Therapy have been witnessed for thousands of years. BioMonde has brought the therapy into
the 21st century by containing the benefits in the easy to use, contained BioBag dressing. Larval Therapy is a rapid
and efficient way to clean a wound and debridement can be achieved in as little as one treatment. Larvae are able
to remove what cannot always visually be identified as being unviable tissue or bacterial burden which are two
things known to stall wound progression. Larvae actively remove devitalized tissue and bacteria (including MRSA
and biofilm) from a wound and because their secretions are selective and precise the larvae cannot take away any
healthy or viable tissue.
Note: Specific indications, contraindications, warnings and side effects exist for BioBag.
Further information can be obtained in the Instructions for Use, or by visiting www.biomonde.com
If you are going to be caring for your larvae at home please see our Patient Home Care Guide for further instructions.
We wish you every success on your journey towards wound healing.
How big are the larvae?
What does the treatmentprocess entail?
Will I feel the larvae on my wound?
It might surprise you to hear that the larvae of the greenbottle fly
species we use, Lucilia sericata, is very small. Smaller than larvae you
may have seen on television and definitely smaller than the image you
will have in your mind. They are around 2mm in length when they are
first applied to your wound and they grow to around 10mm after four
days of removing nutrition from your wound.
BioBag is very easy to use and is simply placed on top of your wound
much like a conventional dressing. The BioBag is covered with moist
gauze and a breathable wound pad and the dressing is secured using a
bandage or tape. From the outside it should look the same as your usual
dressing. Each BioBag treatment stays in place for up to four days and
the outer dressing is changed daily.
The BioBag can be applied at your home, in any healthcare facility or
outpatient clinic. On average one to three treatments are needed to
achieve successful wound cleaning. Your healthcare practitioner should
assess your wound at application and at the end of the treatment to
ensure successful debridement or that the correct follow-on treatment
Most people are unaware of the larvaes presence, although it would be
normal to feel a tickling, pulsating or tingling sensation. Dont forget
the larvae are contained within the BioBag dressing. Some patients,
particularly those with poor circulation or painful/sensitive wounds, can
experience an increase in pain during the treatment but this is typically
controlled with pain relieving medication.
Patient Information Guide