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WOUND MANAGEMENT

Collagen:
Its Role in Wound Healing
Heres an update on the practice management
of this treatment.
By Alec O. Hochstein, DPM and Animesh (Andy) Bhatia, DPM

What Is Collagen? healing, proteases such as MMPs, There are a number of different
Collagen is the most abundant are attracted to the wound during collagen dressings available that use
protein in the human body and is a the inflammatory phase and have a variety of carriers and combining
major component of the extracellu- an important role in breaking down agents such as gels, pastes, polymers,
lar matrix (ECM). It is comprised of unhealthy ECM so that new tissue and oxidized regenerated cellulose. 103
three polypeptide chains that are rich forms. However, when MMPs are The collagen contained in these prod-
in hydroxy-proline amino acids and present in a wound at elevated levels ucts also varies in type and source.
are twisted together into a triple-heli- for a prolonged period of time, this Certain dressings contain native (type
cal structure. results in the destruction of healthy I) collagen in which the triple helix
Over 20 different types of colla- ECM, which is associated with de- formation is intact; others contain
gen have been identified in humans; layed wound healing and an increase denatured or reconstituted collagen,
the main types are type I, II, and III; in wound size. which is referred to as gelatin.
and together they make up 80% of When the excess of MMPs is not Most collagen dressings contain
the bodys collagen. Type I and III
are important for wound healing.

Role of Collagen in Wound


Collagen plays an important role
Healing in each of these phases of wound healing due to its
In a healing wound, a cascade
of events occurs and is broken into chemotactic role.
what is known as the phases of
wound healing. These include plate-
let accumulation, inflammation, fi- balanced by normal physiological collagen derived from bovine and
broblast proliferation, cell contrac- processes, alternative methods are porcine sources. Although these col-
tion, angiogenesis and re-epitheliali- required to reduce protease levels in lagens are purified, there remains
zation. This cascade ultimately leads the wound. This suggests a role for a theoretical concern regarding the
to scar formation and wound remod- dressings containing collagen in the potential for prion diseases such as
eling. management of wounds where heal- bovine spongiform encephalopathy.
Collagen plays an important role ing is stalled (Rangaraj, et al., 2011). There have also been concerns re-
in each of these phases of wound garding the integration of porcine col-
healing due to its chemotactic role. It What are Collagen Dressings? lagens into scar tissue, while cultur-
attracts cells such as fibroblasts and Native intact collagen provides a al/religious issues may prevent their
keratinocytes to the wound. This en- natural scaffold or substrate for new use on some patients. Human-de-
courages debridement, angiogenesis tissue growth. Dressings containing rived collagens are linked with fewer
and re-epithelialization. collagen are thought to provide the immunological concerns; however,
A chronic wound is stalled at one wound with an alternative collagen they tend to be more expensive than
of these healing stages. This usual- source that can be degraded by the animal-derived collagens.
ly occurs during the inflammatory high levels of MMPs as a sacrificial
phase and is linked to elevated levels substrate, leaving the endogenous Collagens and Wound Healing
of matrix metalloproteinases (MMPs) native collagen to continue normal Bringing successful wound care
in the wound. In normal wound wound healing. Continued on page 104

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WOUND MANAGEMENT

Collagen (from page 103) wound healing. Collagens were thus considered bioac-
tive in having a physiological activity beyond moisture
protocols into a podiatric practice requires familiari- management.
ty with the available wound products, as well as their Wounds cannot heal without growth factors in the
intended and appropriate use depending on the type right places at the right times in the right quantities.
of wound presentation the practitioner is presented MMPs also degrade growth factors (e.g., protein chains)
with. that regulate cell populations and activity. Inflammation
Collagen has been used widely within wound care, and the production of MMPs can be prolonged due to
and in multiple forms for different reasons. The mul- failure to completely remove necrosis or debris or by the
tiple forms of collagen lend themselves to a variety presence of microorganisms in numbers beyond critical
of wound presentations, making it a favorite among colonization. Microorganisms contribute to the MMP mix
wound specialists. and stimulate inflammatory mediators and cells, trapping
It had become apparent that chronic wounds were the wound in the inflammatory phase of healing. Many
trapped in the inflammatory phase of wound healing and discussions focus on the need to reduce bio-burden, and
would not progress to healing without resolving inflam- collagen products that contain silver have been intro-
mation. During the inflammatory phase, a wound at- duced to this effect.
tempts to cleanse itself of all non-viable tissue and debris
by utilizing digestive enzymes to break down non-vital Collagen Dressing Types and Uses:
tissue and exudate to wash away the debris. Collagen dressings are available in:
The major classes of enzymes responsible for di- Powders
gesting non-viable tissue (largely collagen) are the ma- Amorphous gels/pastes
trix metalloproteases (MMPs), including several that Gel-impregnated dressings
digest collagen. The current justification for use of With and without adhesive borders
104 collagen dressings suggests that they provide a sacri- Standard-size wound dressing pads
ficial substrate that diverts the MMPs from digesting Ropes for undermining or cavity wound fill
newly formed tissue and by tipping the balance towards
Collagen is often combined with other substrates to
provide additional properties such as gelling (alginate) or
the expansion of enzyme removal to elastase (ORC-ox-
idized regenerated cellulose). Some products promote
native long-chain collagen as superior for scaffolding and
activation of growth factors, while others promote dena-
tured (partially broken-down) presentations for their abil-
ity to provide high numbers of active binding sites that
rapidly interact and remove offending MMPs and high
levels of amino acids for use in building new collagen
structures. Newer classes promote the use of Activated
or hydrolyzed collagen which are immediately bioactive
and are readily taken up by the cellular matrix of the
wound.
Collagen dressings can be tried for jumpstarting
wounds that are stalled in the inflammatory phase, as
they may be responsible for reducing inflammation as
well as pain (or the results and mediators of inflam-
mation). They have been shown to attract and activate
fibroblasts (proliferative stage cell population) and may
provide an organizing or scaffolding effect.

Activated, Native, Processed and Denatured


Collagens
Native collagen materials present a more natural 3-D
structure that may provide a more natural environment
for fibroblasts and better targets for MMPs. They also
bind better to elastin and may aid in conserving elastin
levels.
Processed or denatured collagen may provide a more
readily available source of amino acids necessary for tis-
sue reconstruction and a higher number of exposed active
sites to divert MMPs from digesting newly formed tissue.
Continued on page 105

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WOUND MANAGEMENT

Collagen (from page 104) dispensable and reimbursable prod- Current clinical information
uct can have significant financial im- which supports the reasonableness
Advances in Wound Dressings pact for the dispensing wound care and necessity of the type and quan-
Over the last 30 years, there has practice. Podiatrists have been very tity of surgical dressings provided
been a shift from traditional wound effective at enhancing outcomes for must be present in the patients med-
dressings towards those advanced patients by dispensing orthotic de- ical records. Evaluation of a patients
therapies that aim to optimize the vices, braces, and splints at point of wound(s) must be performed at least
wound healing environment (Enoch service. Wound care products can be on a monthly basis unless there is
and Harding, 2003). In more recent as significant, if not more so, for our documentation in the medical record
years, wound care products have patients and the bottom line. which justifies why an evaluation
been developed that aim to replicate Most insurers reimburse DME. could not be done within this time-
or add to the ECM. The ECM is the Medicare, which handles these de- frame and what other monitoring
major component of the dermis and vices through one of four Durable methods were used to evaluate the
provides a structural support for cells, Medical Equipment Regional Carriers patients need for dressings.
growth factors, and receptors that are (DMERC), requires a separate provid- Evaluation is expected on a more
essential to wound healing. The ideal er number in order to submit claims. frequent basis (e.g., weekly) in pa-
dressing should achieve rapid healing Information defining the num- tients in a nursing facility or in pa-
at reasonable cost with minimal im- ber of surgical/debrided wounds tients with heavily draining, infect-
pact on the patients daily activity. being treated with a dressing, the ed wounds or those wounds where
reason for dressing use (e.g., surgical there have been significant clinical
DMERC Reimbursement Model wound, debrided wound, etc.), and changes. The evaluation may be
and Documentation Requirements whether the dressing is being used performed by a nurse, physician, or
The benefits of using collagen in as a primary or secondary dressing other healthcare professional. This
the podiatric office extend beyond or for some non-covered use (e.g., evaluation must include the type of 105
the efficacy it affords patients for wound cleansing) must be included each wound (e.g., surgical wound,
their wounds. Collagen as a DMERC in your documentation. Continued on page 106

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WOUND MANAGEMENT

Collagen (from page 105) other supplies) and then send them when to use said products.
to a pharmacy, or arrange for a home Wound dressings are a covered
pressure ulcer, burn, etc.), its loca- delivery company to mail them the benefit under Medicare Part B if they
tion, its size (length x width in cm.) products, the likelihood of the patient are medically necessary, and if they
and depth, the amount of drainage, following your instructions accurate- are used in the treatment of a wound
and any other relevant information. ly is slim at best. caused by or treated by a surgical
Additionally, the care may not procedure.
Dispensing Products in a Podiatric
Medical Office
Why should a podiatrist dispense
wound products from the office? The The patient leaves your office
most important reason is that it will with exactly what you want them to have,
lead to better compliance and out-
comes. The patient leaves your office right away.
with exactly what you want them to
have, right away. The convenience
factor: no trips to the pharmacy, no start immediately. When the patient In general, for wound supplies
waiting for it to arrive in the mail, no receives a large intimidating box with to be a covered benefit, the wound
delays. Patients have a clear under- a whole bunch of instructions, this must be full thickness (this requires
standing of what needs to be done, obviously isnt a good thing for your a wound grade and documentation of
and they are more likely to be com- patient or for you. It isnt hard to depth in your note)
pliant. Whats more, it makes your imagine how much better it would Documentation must indicate
practice look comprehensive, leading be for the patient when you dispense some type of debridement(s) hav-
106 to more referrals. the products, you bill their insur- ing been done at some point in the
When you write a prescription for ance for the products, and you (or course of treatment.
your patients wound dressings (or your staff) show the patient how and Continued on page 109

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WOUND MANAGEMENT

Collagen (from page 106) bridement method, and depth of tis- DME supplier has to comply with,
sue removed. It must also include print, and hand a copy to the pa-
Remember that patients are not the appearance of the wound bed, tient could be printed on the back of
eligible for coverage for wound dress- stage or grade, and presence of in- the above goods receipt form, and a
ings provided by a physician supplier fection. Wound measurements must one page double-sided copy could be
if they are in hospice or on a home be documented at least monthly. provided to the patient. Rigorously
healthcare plan (for any reason), or The wound must be full thickness, implementing the numerous require-
if they are in a Part A stay or in a at least Wagner Grade 2 or NPUAP ments of these 30 standards is obvi-
skilled nursing facility (place of ser- Stage 3 and must be debrided at ously the first step to dispensing any
vice 31). some point. but not necessarily on DME and must be adhered to before
Check DME HCPCS Codes for the day of dispensing. any of this is done.
Surgical Dressings and PDAC Prod- 2) Prescription: This could either 5) Instructions: Written instruc-
uct listings for the most appropriate be a separate form on file or within tions on the use of the product must
code for the product being dispensed. the progress note and must include be provided. Again, this is a matter
WWW.DMEPDAC.COM name or type of product, size of of a one-time effort of making an
When billing for wound care dressing, amount needed, frequency instruction form for every product
products, submit claims to the appro- of change, and expected duration of in the office intended for dispensing.
priate DME MAC or private insurance need. A new order is needed if a) the Or, if the product comes with instruc-
with the appropriate diagnoses, the quantity or frequency of the dressing tions in its insert, that is sufficient.
HCPCS code for the product, the num- is increased, b) a new dressing is 6) Purchase Receipt: Receipts
ber of units dispensed, and finally the started, or c) three months, whichev- must be able to be provided showing
modifier A*, where * is the total num- er comes first. the purchase of the products supplied.
ber of wounds being treated. 3) Patient acknowledgement
Once a system and protocols are of receipt of goods form: This form Next, set up basic protocols for 109
established, the benefits will immedi- should have warranty and complaint the most common types of wounds.
This will ensure consistent and effi-
cient delivery of care. The protocols
must be comprehensive to include
Inventory concerns can be kept to a minimum
vascular and neurological testing,
by stocking a few nationally-used products offloading, compression, infection
management, biologic products,
in each category. and debridements. Inventory con-
cerns can be kept to a minimum by
stocking a few nationally-used prod-
ately become obvious. Training your resolution information in it. It must ucts in each category. The choice
staff to know how to handle and be signed by the patient or respon- of products has been the subject
apply these products, along with get- sible party, and it must include the of many articles and can easily be
ting all of the compliance templates name of dressing, size, number narrowed. The shelf life of prod-
set up, will be essential steps to en- given, and frequency of change. Such ucts nowadays is in the range of
sure compliance. Also, you cannot forms can easily be created listing two years. Follow this with a little
bill for the dressings you apply in the only the particular items in stock at training of the staff to learn their
office; those are considered part of the office with easy check-off boxes. function and appropriate use; then
your office visit charge (incident-to). A copy of this must be offered to a get the paperwork in order, follow
Some fine tuning would be necessary patient who wants one. Here it is im- the billing guidelines, and you are
after checking with the requirements portant a) to be aware of the amount ready to go!
of the respective DME MAC covering of dressings the DME MAC allows
your state. Per claim submitted, es- to be dispensed per month for each Case Presentation 1
sentially there are six documents that category of dressing and b) only dis-
are needed: pense a maximum of a months sup- Wound Type: Diabetic Ulceration,
1) Progress note: This is what ply at a time, no more. Post-op Necrotizing Fasciitis
will justify medical necessity for For example, you can dispense
the product you have dispensed. It up to 30 pieces of a collagen prod- Wound Presentation
must be a detailed assessment of uct for a patient with a full thick- Patient presents to author three
the wound(s) with medical deci- ness wound per wound per month. weeks status post incision and drain-
sion-making leading to the ultimate The same is true for saturated gauze age, including right 5th digit amputa-
decision to prescribe and dispense and calcium alginates. For foams, tion and partial ray resection (Figure 1).
the product appropriate for the up to 12 pieces can be dispensed per The patient had been diagnosed with
wound. The description must include wound per month. a necrotizing fasciitis of the left foot.
type of wound, location, size, depth, 4) 30 Supplier standards form: After adequate and emergent incision
amount and type of drainage, de- This list of standards, which each Continued on page 110

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WOUND MANAGEMENT

Collagen (from page 109)

and drainage, the patient


was left with a large soft
tissue defect that included
exposed extensor tendons.

Initial Presentation
Sharp debridement
of the right foot wound
edge, application of top-
ical CellerateRx Gel, pe-
troleum gauze, moist
gauze applied, light com-
pressive top cover
Size: L = 10cm W=
6cm D=.5cm
Wound Base: Granu-
Figure 1: Diabetic ulceration, post- Figure 2: Wound at week 4. Figure 3: Wound healed at week 12.
lar with extensor tendon op necrotizing fasciitis.
exposed
Exudate: moderate se-
rosanguanous

110 4 Weeks (Figure 2)


Sharp debridement
of the right foot wound
edge, application of top-
ical CellerateRx Gel, pe-
troleum gauze, moist
gauze applied, light com-
pressive top cover
Size L =8cm W=
5cm D=.25cm
Wound base granular
without exposed tendon,
peri-wound hyperkeratosis.
Exudate scant sero-
sanguanous Figure 4: Venous status ulcer. Figure 5: Wound at week 1. Figure 6: Wound healed at 5 weeks.

12 Weeks (Figure 3) apply to wound daily after cleansing


Sharp debridement of the right with saline, and then caregiver was
foot wound edge, application of Topi- to wrap leg with a three-layer com-
cal CellerateRx gel, petroleum gauze, pression dressing. Dr. Hochstein is
Medical Director of
moist gauze applied, light compres- One week later, patient presents
Wound Management
sive top-cover with wound showing some macera-
Technologies.
Size: Wound closed tion but significantly reduced non-via-
Wound BaseEpithelial ble tissue, and increased granulation.
ExudateNONE Sharp debridement was per-
formed, application of Celle-
Case Presentation 2 rateRx powder, alginate pad, and Dr. Bhatia is Asst.
a three-layer compression dressing. Medical Director, Fair-
Wound Type: Venous Stasis Ulceration Instructions to continue same treat- field Medical Center
ment at home as before (Figure 5). Would Clinic and a
member the APMA
Wound Presentation The same process was continued
Coding Committee. He
Patient presents to author with weekly for the next four weeks, and
also serves on State of
chronic draining venous stasis ul- on this visit the wound was com- Ohio Prosthetics and
ceration (Figure 4). After extensive pletely healed with healthy epithelial Orthotics Board, the
sharp debridement of wound and ad- tissue and no drainage (Figure 6). Board of Trustees of
equate cleansing, the patient was dis- Ohio Foot and Ankle Medical Association, and
pensed with CellerateRx Powder to Total healing time: 5 weeks PM the Board of AAPPM.

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