Neogenix, LLC dba Ogenix

www.ogenix.com

Protocol for EPIFLO - for both Inpatient and

Outpatient Use
Protocol Version Number: 1.6
June 24, 2015
Revision History Version 1.0: 02/15/2011;Version 1.1: 11/19/11;Version 1.2: 6/18/12,
Version 1.3: April 26, 2013;1.4: October 2013;1.5: April 2015

3401 Enterprise Pkwy, Suite 340 Beachwood, OH 44122

588 Pleasant St., Unit 2, Norwood MA 02062 Phone 781-7026732 Fax 781-702-6293
Corporate Offices: 2001 SW 20th Street, Suite
102, Ft. Lauderdale FL 33315 Phone: 561-300-4001

Table of Contents
TABLE OF CONTENTS...............................................................................................................................................................2
1.

PRODUCT NAME AND DESCRIPTION....................................................................................................................3

2.

REGULATORY APPROVAL.........................................................................................................................................3

3.

INDICATIONS AND CONTRA INDICATIONS.........................................................................................................4

4.

WHO WILL BENEFIT FROM EPIFLO......................................................................................................................4

5.

SUBJECT SELECTION CRITERIA FOR INITIAL TRIAL OF EPIFLO..............................................................4

6.

SUMMARY OF KNOWN POTENTIAL RISKS AND BENEFITS TO STUDY SUBJECTS.................................5

7.

DRESSING SELECTION GUIDE................................................................................................................................6

7. APPLICATION PROCEDURE...............................................................................................................................................7
7.1. DIABETIC AND PRESSURE ULCERS........................................................................................................................................7
7.2. EXAMPLE OF THE USE OF EPIFLO FOR VENOUS LEG ULCERS (WITH COMPRESSION DRESSING).....................................8
7.3 USE OF EPIFLO WITH SKIN-EQUIVALENT GRAFTS............................................................................................................8
7.4 SURGICAL COMPLICATIONS AND INFECTED WOUNDS..........................................................................................................9
7.5 DRESSING CHANGE PROCEDURE..........................................................................................................................................9
1.

WHAT TO EXPECT AFTER APPLICATION OF EPIFLO......................................................................................9

2.

COMBINATION WITH OTHER THERAPIES........................................................................................................10

3.

DOSAGE, ADMINISTRATION, STORAGE AND DISPOSAL...............................................................................10

4.

PUBLISHED PAPERS & PRESENTED POSTERS ON EPIFLO .........................................................................12

5.

APPENDIX I. SUMMARY.........................................................................................................................................14

6. APPENDIX II. APPLICATION INSTRUCTIONS GRAPHICS.....................................................................................14

1. Product Name and Description

This protocol is for EPIFLO Transdermal Continuous Oxygen Therapy (TCOT).
Components of this unit include:
EPIFLO 15 TCOT device,
A small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to
100% oxygen (balance moisture) for 15 days at a rate of ~3.0 ml/hour; and 4 60 long sterile
cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying
the wound. EPIFLO is supplied with a Pouch & Armband, which may be used to secure the
device to the patient.
EPIFLO is designed to provide transdermal, continuous oxygen therapy delivery to chronic
wounds. EPIFLO concentrates oxygen from atmospheric air and delivers the concentrated
oxygen to the region of the wound bed. This creates an oxygen-enriched environment intended
to promote the healing process in chronic wounds as an adjunct therapy in wound management
and treatment. The etiologies of many chronic wounds, including diabetic wounds, are linked
to poor oxygen delivery to cells from impaired circulation. Increasing oxygen concentration
above chronic open wounds with the use of transdermal, continuous oxygen delivery promotes
healing and may suppress bacterial growth.
EPIFLO can be worn in a convenient location in the body within 4-5 feet of the wound or even
closer per patients preference, beneath clothing without impairing its operation, and the patient
is free to ambulate and continue with normal daily activities while being treated 24 hours per
day for 15 days. The EPIFLO unit measures 2 x 2.5 x 1 and weighs 3.5 oz. A pouch (with belt
loop) and arm band are provided to facilitate wearing of the device.

2. Regulatory Approval
EPIFLO was cleared by the FDA for marketing in the U.S. as a Class II medical device, under
510(k) K120764 , on April 27, 2012. Earlier, on Feb 24, 2003, it was also cleared as a preamendment Class III medical device (510(K) No. K023456).
EPIFLO has been cleared by Health Canada for marketing in Canada as a Class II medical
device. The license (#72614) was issued on October 25, 2006.
EPIFLO was awarded the CE Certification (CE 542485) on Feb 18, 2009

3. Indications and Contra Indications

EPIFLO provides safe and effective transdermal, continuous oxygen delivery for the treatment
of:
3

Skin ulcerations due to diabetes, venous stasis, post-surgical

infections and gangrenous lesions;
Pressure ulcers
Amputations and infected stumps;
Skin grafts;
Burns; and
Frostbite.

The EPIFLO system is contraindicated for the following:

Inadequate perfusion to support healing;

Ulcers due to acute thrombophlebitis;
Ulcers due to Reynauds disease;
Necrotic wounds covered with eschar or slough
Wounds with fistulae or deep sinus tracts with unknown depth
Wounds covered with petroleum-based dressings.

4. Who will benefit from EPIFLO

- A motivated/compliant patient
- A wound of appropriate size - the rule of thumb we use is a wound ~ 40 - 50 sq cm or
smaller if only one device is being used. More than one device can be used on the same
wound (for larger wounds).
- A wound with adequate perfusion - ideally 0.7, but clinicians have applied EPIFLO to
wounds with ABI as low as 0.4.
- A wound that is off-loaded properly - Total Contact Cast, Unna boot or walker boot are
standard offloading methods. EPIFLO can be used in conjunction with all of them.

Inpatient subjects are more compliant (since they are bed-ridden) and there is
an opportunity for daily care by the clinician in an inpatient setting. Dressing
change twice a week or more frequently if needed (e.g., heavy drainage) is
easier in an inpatient setting.
5. Subject Selection Criteria for initial trial of EPIFLO

Wounds of duration 5 years EPIFLO has been used in wounds >5 years; however for
subjects with non-healing wound > 5years, there may be other underlying issues that
prevent proper wound healing. Clinical judgement is advised. If progress is indicated after
four weeks of treatment, treatment with EPIFLO should be continued.
Subjects with ulcer that has a total Surface Area of greater than 50 cm2 at Screening Visit
Not to be used in patients with severe gangrene on any part of affected limb; however,
EPIFLO could be utilized to demarcate the gangrenous area.
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Not to be used on subjects with active Charcots foot on the study limb, unless
accompanied with total contact casting with complete non-weightbearing.
EPIFLO can be used on subjects with infected target ulcers, accompanied by cellulitis,
known or suspected osteomyelitis, or other clinical evidence of infection, provided
appropriate antibiotics are administered in conjunction with EPIFLO.

Interdigital ulcers EPIFLO use needs additional splintering and additional dressing
to ensure oxygen atmosphere is maintained on the wound surface. Sealing of the
wound in such anatomical location is difficult and care should be exercised to proper
sealing of the wound to ensure retention of oxygen on the wound surface.

EPIFLO can be used on Stage IV wounds, with caution exercised not to place the
cannula directly on the tendon/bone.

Present or past malignancy on study limb

Subjects currently taking steroids >7mg dosage

Subject allergic to a broad spectrum of primary & secondary dressing materials,

including occlusive dressings and the adhesives on such dressings.

6. Summary of Known Potential Risks and Benefits to Study Subjects

In summary, clinical development to date suggests that the EPIFLO is expected to have no
significant safety issues when used properly and to be well tolerated. To date, no serious
adverse events and no incidents of dermatological toxicity have been reported.

7. Dressing Selection Guide

EPIFLO is known to enhance drainage (in most cases) in the first two weeks of application. Therefore
appropriate dressings should be used to absorb the extra drainage and prevent maceration.
Non-draining to minimal draining wounds: If wounds are dry,
temporary use of saline gel is recommended
Moderate drainage
Foam (or equivalent) or Hydrofiber (e.g., Aquacel)
Heavy drainage
First layer of a wicking dressing (e.g., Therabond or Drawtex)
Alginate (or hydrogel dressing) + foam on top of the wicking
dressing

In all cases: top layer: An occlusive film dressing, e.g.,

Tegaderm HP, Opsite*
As needed
Therabond or Drawtex to prevent maceration (Therabond
releases silver, Drawtex is plain hydroconductive dressing)
Periwound skin protection application: e.g., Marathon or tincture
benzoin (if no allergies)
If allergy to silver is observed in rare cases,
(polyhexamethylene biguanide) based dressings can be used.
Note; no transparent Non-adherent contact layer
*= If the patient has fragile skin, thin film dressings may not be the best choice. Several
layers of gauze may be used to prevent oxygen leakage to the atmosphere.
Clinical judgment should be used to determine what the best dressing is for the individual and
their wound care.
No ointments to be applied while using Oxygen therapy.
Wet-To-Dry dressings are discouraged.
Saline cleansing is recommended.

For other compatible dressings, please refer to our Publication Clinical Users Guide page 8

7. Application Procedure
7.1. Diabetic and Pressure ulcers
Cleanse the periwound using a suitable surfactant, ensuring to remove any oils, creams or
lotions AND/OR
Cleanse the wound with 100cc of sterile normal saline
Pat dry the wound base with non sterile gauze.
Surgically debride the wound (to be done by a qualified member of the clinical team), (if) as
necessary. The wound base will be made (at least) 75% (by area) clean of any slough or eschar.
Remove the Package Insert (also called IFU) from the EPIFLO package and review as needed.
Remove EPIFLO device from the plastic package, and locate the on-off button near the Luer- end
of the device.
Using finger nail, the slide switch will be pushed in the direction of the arrow marked ON.
(The slide switch may be difficult to move to this ON position; this is a design feature of the device to protect
against accidental turning off during the treatment period. This action will activate the device, as evidenced by the
five quick flashes of the indicator light on the top of the device. After the five rapid flashes, the indicator device
will blink once every five seconds.)

Once activated, set aside the device.

Using sterile techniques, remove the cannula from the cannula packet, and attach to the Luer loc
located on the side of the EPIFLO lid area and tighten to optimal finger strength (same as
handling any other Luer Lock in the clinic environment).
Determine where the patient will be most comfortable wearing the EPIFLO device and measure
along the path of the cannula to insure that there is enough length of cannula to reach from the
wound to the EPIFLO device.
Apply a 1 x 2 strip of either a foam or a hydrocolloid dressing to the very edge of the wound
that is farthest from the foot. (The periwound area of wounds in most patients is very fragile. It is important
that the cannula does not pit into that area causing additional ulcers. To prevent such happenings, it is necessary to
off-load the cannula tubing around the periwound area.)

Place the tip of the cannula at the center of the wound bed, and secure to the chosen dressing
(see Dressings Selection Guide at the end of this section) with medical tape.
The tip of the cannula and the entire wound bed will be covered with the chosen dressing, and
secured with a transparent film dressing. The transparent film dressing will cover the entire
length of the primary & secondary dressing. The transparent film will allow the oxygen to be trapped
(between the film and the wound bed) and must hence be properly adhered to the periwound skin. A 1-2 margin
of transparent film dressing along the edges of the wound will be maintained.

The transparent film will be pinched around the cannula to reduce any chances of oxygen
leakage.

Secure the EPIFLO may to a desired location on the subjects body.

The cannula may be tunneled up the subjects leg beneath the trouser, shorts, skirt, etc., and
pulled out of the waist band.
A pouch and an arm band are provided for each patient. The pouch is used along with the belt
and the arm band can be used to place the device either on the arm or on a suitable location in
the lower extremity.
Secure the cannula by tape at various points along the patients leg.
If there is an excess length of the cannula, it can be wound and taped over the dressing, to an
out of the way spot along the patients leg, making sure the cannula is padded and does not dig
into the skin or to the EPIFLO itself;
Make sure the air flow into the EPIFLO unit is not restricted. EPIFLO may be placed into the
subjects pant pocket or into a fanny pack that is unzipped 25%( make sure the patient is careful that the
EPIFLO will not fall out and collide with a hard object or the floor). It is very important not to block the
seam that separates the two halves of the EPIFLO that extends from the off position switch all the way
around the unit to the on position switch. The seam cannot be completely covered at any time. This is
where atmospheric air is drawn into the EPIFLO and if this seem is blocked the unit will not function to
produce oxygen to supply the the wound. EPIFLO may also be worn in the subjects sock.

The skin underneath the EPIFLO unit will be protected by placing a small gauze pad or several
wraps of gauze between the unit and the skin.
7.2. Example of the use of EPIFLO for Venous Leg Ulcers (with Compression
Dressing)
(for detailed description and pictorial guide, consult the EPIFLO Clinical Users Guide as well as the
EPIFLO Application Video).
Step One:
Cleansing and wound prep is the same as above
Step two
Place the sterile EPIFLO cannula beneath an absorbent and/or anti-microbial dressing in the
centre of the wound bed; run the foam padding underneath the cannula all the way through the
compression dressing to avoid pitting of the cannula into the leg, especially in those patients
with edema.
Step Three:
A compression dressing is secured to the leg according to the manufacturers instructions for
use. The cannula is weaved outside each successive wrap of the compression dressing
Step four:
The compression dressing can be covered with a protective bandage and EPIFLO is secured
into place with tape. Alternatively, EPIFLO can be positioned elsewhere on the patient

7.3

Use of EPIFLO with Skin-Equivalent Grafts

EPIFLO is best utilized in the preparation of the proposed graft site two weeks prior to the graft
procedure, to enhance granulation tissue and allow the graft to be more successful. In addition
EPIFLO may be continued with the graft to enhance its acceptance. All standard dressings
would apply with this technique. EPIFLO can also be used with rotation or free grafting
procedures.
7.4 Surgical Complications and Infected Wounds
When treating infected wounds, a silver dressing may be utilized with EPIFLO. All surgical
complications and infected wounds would often require antibiotic therapy as well. EPIFLO has
been shown to reduce bacterial bioburden (Coutts and Sibbald, 2010.)
7.5 Dressing Change Procedure
The prescribed dressing must be changed by the subject and/or caregiver at home, when
clinically indicated (i.e. dressing saturation, leakage, excessive bleeding, and increased pain) or
after a maximum of seven days. The time that it takes for the dressing to become saturated will
vary from subject to subject. The wound must be assessed at least once a day to determine if the
dressing needs to be changed. The investigator will be advising the patient about dressing
changes, and that advice should be followed strictly by the patient.
If the dressing needs to be changed, the dressing must be removed. This can be done by lifting
diagonal corners of the thin film dressing and stretching it, pulling it away from the center of
the wound in a horizontal fashion. This technique will break the adhesive bonds of the dressing
and allow the dressing to be removed with minimal trauma. The wound may be cleansed with
normal saline, and redressed. If the wound remains dry, the dressing need not be changed.
Dressings must only be changed when saturated (typically every few days or as necessary) or
after 7 days maximum! (according to the manufacturers guidelines and instructions for use) .
Note that the dressing change frequency depends on the level of drainage e.g., a heavy
draining wound would require dressing changes every 48 hours or less. It is normal to get
some heavy exudate during the first 2-5 days and sometimes up to the first two weeks of
EPIFLO application.

1.

What to Expect after Application of EPIFLO

The EPIFLO has some rather consistent milestones which help determine if one should
continue treatment beyond the first unit. Changes begin to occur within the first few days and
continue into the second week prior to the expiration of the 15 day period of the first unit used
in therapy.

A drainage increase often begins somewhere around day 2-5 and is usually over by day 8.
In unusual cases it will last longer and when it does, it more than likely has nothing to do
with EPIFLO but rather with Edema or infection.
During the first week, we seldom see any visual cues of healing if pain is prevalent
there is often a reduction or elimination of pain from day 2 to day 7 and often it does
not return.
During the second week a number of wound healing indicators can be observed
including: area and depth reduction, change in wound edge, change in wound shape, and
granulation Epithelialization is seldom seen at this point but it sometimes happens
along the wound edge or a small islands within the interior of the wound. (in the areas of
previous granulation)
If the wound does have increased drainage it is important to manage the exudate levels to
reduce the chances of maceration It is recommended to utilize whatever is used by the
facility to control this condition [ e.g. - a heavy absorbing primary dressing (alginate,
hydrofiber) and a foam secondary dressing .] When the dressing is saturated it should
be changed but changing before then or too often will affect the performance for the
oxygen, in that it will not allow the oxygen trapped beneath the dressing time enough to
penetrate the wound. Some success has been reported with the use of maceration
preventing aids, e.g., MarathonTM Skin Protectant (Medline Industries). This product is
resistant to external moisture, and thus prevents maceration. Other aids such as tincture
benzoin can also be used for this purposed in the periwound area.

If some of the wound changes listed above occur, EPIFLO treatment should be continued. If
consistent improvement is seen week to week, EPIFLO should be continued until complete
closure of the wound.

2. Combination with Other therapies

EPIFLO has been successfully used with skin equivalents or allografts. It can also be applied
with ultrasonic debriding. While it cannot be used in conjunction with NPWT, before and in
between application of NPWT may have some benefits, especially with large wounds and
wounds with significant edema. A number of cases show evidence that EPIFLO can be used
after the effects of NPWT have stalled.

3. Dosage, Administration, Storage and Disposal

Dosage: Each new, single-use EPIFLO unit provides transdermal, continuous oxygen delivery
for 24 hours per day for up to 15 days. After 15 days, the unit may no longer deliver oxygen at
therapeutic levels. Hence, after 15 days, the used EPIFLO unit must be discarded and therapy
continued with a new EPIFLO unit.

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Administration: Subjects in the study will be administered the EPIFLO unit every two weeks,
until the wound heals completely-as exhibited by complete wound closure (wound covered with
Epithelia). Typically, diabetic wounds heal in approx. 7-8 weeks. EPIFLO devices are safe for
use until the expiry date listed on the device cover. (They may be applied until 15-days prior to
the last day of the month of expiry and then worn until the end of the month or when the
flashing light expires). On achieving wound closure, the subject is followed for an additional 2
weeks to ensure closure is maintained.
Storage: EPIFLO will be stored as follows:
At room temperature (approximately 15-25 degrees C)
Disposal: For disposal of the EPIFLO unit, leave the unit switch in the ON position to fully
discharge the batteries. The EPIFLO unit contains lithium thionyl chloride batteries that cannot
be recharged. Disposal methods will depend upon local regulations. Consult the waste
management division (of the participating facility) or your local government for appropriate
disposal instructions.
Lithium batteries are neither specifically listed nor exempted from the Federal Environmental
Protection Agency (EPA) hazardous waste regulations, as conveyed by the Resources
Conservation and Recovery Act (RCRA). The only metal of possible concern in the cell is the
lithium metal that is not listed or characterized as a toxic hazardous waste. Significant amount
of spent cells and batteries that are untreated and not fully discharged are considered as reactive
hazardous waste. Thus, hazardous waste of spent cells and batteries can be disposed after they
are first neutralized through an approved secondary treatment prior to disposal (as required by
U.S. Land BanRestriction of the Hazardous and Solid Waste Amendments of 1984). Disposal of
spent batteries should be performed by authorized, professional disposal company, which has
the knowledge in the requirements of the Federal, the State and the Local authorities regarding
hazardous materials, transportation and waste disposal. In any case it is recommended to
contact the local EPA office.
PROPER SHIPPING NAME: Waste lithium Batteries
UN NUMBER: 3090
LABEL REQUIREMENTS: MISCELLANEOUS, HAZARDOUS WASTE
DISPOSAL CODE: D003
Following are two suggestions for battery recycler and collector in the US:
(1) ToxCo Inc.
3200E Frontera, Anaheim, California 92806
Tel: (714) 879 2076, Fax: (714) 441 0857
http://www.toxco.com/
(2) Intercon Solutions
1001-59 Washington Ave.
Chicago Heights, IL 60411
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Phone: 708-756-9838
Fax: 708-756-4094
Toll Free: 888-452-5642
www.InterconRecycling.com

4. Published Papers & Presented Posters on EPIFLO

PUBLISHED PAPERS
1. CASE STUDIES EVALUATING TRANSDERMAL CONTINUOUS OXYGEN FOR THE
TREATMENT OF CHRONIC SICKLE CELL ULCERS, I. S. Igwegbe, , G. Onojobi, M.
Fadojutimi-Akinsiku, A. M. Hirsh, N. Park, , M.Yao, V.R. Driver, ADVANCES IN SKIN &
WOUND CARE & VOL. 28 (5) 206 (2015)
2. Driver, V.R. et al., Clinical Effects and Underlying Molecular Mechanisms of Transdermal Continuous
Oxygen Therapy on Diabetic Foot Ulcers, To be published in Ostomy Wound Management, 2013.
3. Woo,K.Y., Coutts, P.M., Sibbald, R.G., Continuous Topical Oxygen for the Treatment of Chronic Wounds: A
Pilot Study, in Advances in Skin & Wound Care, 2012; 25:543-547
4. Donald G. Kemp, M.D. , Michel H.E. Hermans, M.D., An evaluation of the efficacy of Transdermal
Continuous Oxygen Therapy in patients with recalcitrant diabetic foot ulcer, The Journal of Diabetic Foot
Complications 2011, Volume 3, Issue 1; No.2, Pages 6-12

5. Said HK, Hijjawi J, Roy N, Mogford J, Mustoe T, Transdermal sustained delivery oxygen
improves epithelial healing in a rabbit ear wound model, Arch Surg 2005, 140 (10): 998-1004
6. Lowell D, Nicklas B, Weiley W, Johnson F, Lyons M, Transdermal Continuous Oxygen Therapy
as an Adjunct for treatment of Recalcitrant and Painful Wounds, The Foot and Ankle Online
Journal 2 (9):4
7. Banks PG & Ho CH, A novel topical oxygen treatment for chronic and difficult-to-heal wounds:
Case studies, J. Spinal Cord Medicine, 31(3), 297 (2008)
8. Hirsch F; Berlin S; Holtz A, Transdermal Oxygen Delivery to Diabetic Wounds: A Study of 6
Cases, Advances in Skin & Woundcare, 22(1), 20, 2009
9. S. Sarangapani, P.V.Mayer and D. Hoffman, Transdermal Continuous Oxygen Therapy using
EPIFLO: A New Tool for Wound Healing, Journal of Wound Technology, July 2010
10. Wilson, C. et al. J. Wound, Ostomy & Continence Nursing, 2005, 32(3S): Supplement 2: S6

POSTERS
1. Clinical Efficacy and Molecular Mechanisms of Transdermal Continuous Oxygen Therapy
(TCOT) in Treatment of Diabetic Foot Ulcer (DFU), N. Park, M. Yao, H. Hasturk, A. Kantarci, G.
Gu MD1, M. French, V. Driver, Poster presented at SAWC Spring 2012.
2. CASE SERIES: TRANSDERMAL CONTINUOUS OXYGEN WOUND THERAPY
for the treatment of complicated foot ulcers, N. Park, DPM, G. Gu. MD, J. Ogbonna DPM, N.
Stuhr-Wulff, MS, G. Gu MD, V. Driver, MS, DPM, FACFAS, Poster presented at DFCon 2012
3. The Use of Transdermal Continuous Oxygen Therapy For The Treatment Of Chronic
Recalcitrant Sickle Cell Disease Ulcers, Ikechukwu S. Igwegbe, Gladys Onojobi, Margaret
Fadojutimi-Akinsiku, and Alan M. Hirsh, Poster presented at SAWC Spring 2012
12

4. Shawn Norris, Svend Bjorn, and Donald Graves, Case Study Evaluation of Transdermal
Continuous Oxygen Therapy (TCOT) as an Adjunct to Human Fibroblast Derived Dermal
Substitute, Poster presented at Desert Foot 2011
5. Patrick Kelly, Chelsea Golden and Luann Carlson RN, The Case for Transdermal Continuous
Oxygen Therapy for Diabetic Foot Ulcer A Case Study, Poster presented at Desert Foot 2011
6. Howard M.Kimmel, The Use of Transdermal Continuous Oxygen Therapy to Accelerate Wound
Healing, Poster presented at SAWC Fall Meeting, 2011.
7. Stephanie Wu and Donald Kemp, Coumadin Necrosis Treatment with Transdermal Continuous
Oxygen Therapy, Poster presented at Spring SAWC 2011, Dallas, April, 2011.
8. Howard M. Kimmel, The Use of Transdermal Continuous Oxygen Therapy as Adjunctive
Treatment to Human Fibroblast Derived Dermal Substitute in Diabetic Foot Ulcers, Poster
presented at DFcon 2011, Los Angeles, March 2011
9. An overview of available oxygen therapies for woundcare, Steven Berlin, David Hoffman and S.
Sarangapani, poster presented at Desert Foot 2010 (2nd place award winner)
10. Effect of Transdermal Continuous Oxygen Therapy on four wounds after treatment with NPWT,
Steven Berlin, Donald kemp, David Hoffman and S. Sarangapani, Poster presented at DLS 2010
11. Successful Treatment of Recalcitrant Chronic Diabetic Foot Wounds with Transdermanl
Continuous Oxygen Therapy: Reviving the Dead(wound) , Perry Mayer MB, BCh, CCFP. The
Mayer Institute. Hamilton, Ontario, Canada, Presented at the APMA meeting at Toronto, ON, July
30, 2009
12. Continuous Local Oxygen Delivery Promotes Wound Healing
- presented at the Symposium on Advanced Wound Care, Las Vegas, NV, 2007
13. Amputation Date Cancelled Due to the Use of Transdermal continuous Oxygen Therapy in the
Healing of a Diabetic Foot Ulcer with Osteomyelitis - presented at the American Professional
Wound Care Association, Philadelphia, PA, 2005
14. Transdermal, continuous Oxygen Therapy Promotes Healing of a Diabetic Foot Ulcer in a Patient
with Osteomyelitis A Case Report, Claire Wilson, Fred S. Hirsh, Steven P. Schmidt, Poster
presented at WOCN, 2005
15. Transdermal continuous Oxygen Therapy (TCOT), A New Paradigm in Wound Care, Adir Ludin,
Claire Wilson, Scott Hirsh, Alan Hirsh, Mel Burk : Poster presented at AAD 2006
16. Transdermal continuous Oxygen Therapy (TCOT) heals chronic diabetic ulcers after other
advanced therapies failed. A retrospective review of 15 patients. Adir Ludin, Claire Wilson,
SAWC 2006
Ogenix Literature:
1.

Package Insert in the EPIFLO Polybag package.

2. Clinical Users Guide

3. EPIFLO Application Instructions I
4. EPIFLO A Patients Guide
5. www.ogenix.com

13

5. APPENDIX I. SUMMARY
1. Thoroughly cleanse the wound and periwound skin. Pat dry.
2. Surgically debride the wound, (if) as necessary
3. Remove EPIFLO from the plastic package, and move the on-off button to ON. Confirm that the
indicator light is on, and set the device aside.
4. Secure the Cannula: Apply a 1 x 2 strip of a foam or hydrocolloid dressing to the edge of the
wound furthest from the foot. Place the tip of the cannula at the center of the wound bed, and
secure to the chosen dressing with medical tape. Place a type of foam dressing beneath the
cannula to prevent embedding.
5. Dress the Wound: cover the tip of the cannula and the entire wound bed with the chosen
dressing, and secure with transparent film dressing. A 2 margin of transparent film dressing
along the edges of the wound will be maintained. The transparent film will be pinched around
the cannula to reduce any chances of oxygen leakage. The transparent film dressing will cover
the entire length of the primary & secondary dressing. Skin Prep can be used to assist in
maintaining a complete seal.
6. Secure the EPIFLO unit: The EPIFLO may be secured to a variety of places on the subjects body
but the cannula must not be cut. A pouch and an arm band are provided for each patient. The
cannula can also be secured by tape at various points with any excess length wound and taped
over the dressing or padding. The seam of the EPIFLO unit cannot be completely covered at any
time. However, the EPIFLO may be worn in the subjects sock or pocket. If secured to the
patients leg, the skin underneath the EPIFLO unit should be protected by placing a small gauze
pad or several wraps of gauze between the unit and the skin.
7. Attach the cannula to the EPIFLO unit: Attach the cannula Luer lock to the oxygen port of the device.
Tighten the cannula (clockwise) to the maximum finger strength.
8. Dressing Selection Guideline:
Non-draining to minimal draining wounds: If wounds are
dry, temporary use of saline gel is recommended
Moderate drainage: Foam (or equivalent) or Hydrofiber
Heavy drainage: First layer of wicking dressing, with Alginate
(or hydrogel dressing) + foam on top
In all cases: top layer: A semi-occlusive film dressing,
As needed
Silver
Periwound skin protection application
If allergy to silver is observed in rare cases,
(polyhexamethylene biguanide) based dressings can be
used.
Note; no transparent Non-adherent contact layer

No ointments to be applied while using Oxygen therapy.

Appropriate Gauze, tape or foam as needed

Clinical judgment should be used to determine what the best dressing is for the
individual and their wound care.

6. APPENDIX II. APPLICATION INSTRUCTIONS GRAPHICS

14