throbber
Skin, Wound,
`LA
`ontinence Care
`
`2OstomyloundManagement
`
`Tae
`
`we.com
`
`November 2002, Vol. 48, Issue 1]
`
`|[P COMMUNICATIONS
` ntemporary Topics
`
`The OstomyFiles
`
`SPECIAL FOCUS: ALTERNATIVE TREATMENTS
`
`My Scope of
`aetoad (a:)
`
`mgte als
`
`Re-introducing Honeyin the
`Management of Woundsand Ulcers —
`Theory andPractice
`Peter C. Molan, BSc(Hons), PhD
`
`Topical Hyperbaric Oxygen and Electrical
`Stimulation: Exploring Potential Synergy
`Laura E. Edsberg, PhD; Michael S. Brogan, PT, MS, CWS;C. David Jaynes,
`PhD; andKristin Fries, PhD
`
`Ultraviolet Light C in the Treatmentof
`Chronic Wounds with MRSA:A Case Study
`
`Thao P. Thai, BScPT, MSc; Pamela E. Houghton, BScPT, PhD; David H.
`Keast, MD, CCFP; Karen E. Campbell, RN, MScN, NP; and M.Gail
`Woodbury, BScPT, MSc, PhD
`
`Mind-Body Techniques
`in WoundHealing
`Karen A. Wientjes, PT, MPH, CWS
`
`}
`
`
`THE UNIVERSITY OF MICHIGAN
`
`
`
`|PASeaAN MEDICAL LIBRARY
`
`NOV 1 9 2002
`
`1
`
`EXHIBIT 1017
`
`1
`
`EXHIBIT 1017
`
`

`

`Editorial Advisory Board OWM
`
`Robert S. Kirsner, MD
`Consulting Editor
`
`Jane Ellen Barr, RN, MSN, CETN
`
`Senford, New York
`
`Janice M.Beitz, PhD, RN, CS, CNOR,
`CEIN
`
`OstomyWoundManagement
`
`y
`
`;
`
`Barbara C.Zeiger
`Epitor
`
`Christine Franey
`VICE PRESIDENT
`OPERATIONS
`
`Patrick Cromer
`CLASSIFIEDS/RECRUITMENTS
`SALES ASSOCIATE
`
`Sheron M. Campbell
`CIRCULATION MANAGER
`
`
`
`;
`Cherry Hill, NewJersey
`BUSINESS STAFF
`EDITORIAL STAFF
`Anne E. Belcher, PhD, RN, FAAN
`Melanie A. Wolfrom
`Robert L. Dougherty
`Lia van Rijswijk, RN, MSN,
`Baltimore, Maryland
`
`
`Nancy A.Faller, RN, MSN, PhD, CETN CHIEF EXECUTIVE OFFICER/——CLASSIFIEDS/RECRUITMENTSCWCN, COCN
`me
`as
`:
`Cuca Eprror
`PRESIDENT
`SALES MANAGER
`Carlisle, Pennsylvania
`seine Fowles; a MN, CEIN
`Banning, California
`Pamela Houghton, BSc PT, PhD
`Elizabeth McTamney
`London, Ontario, Canada
`Richard Geddes
`Peter Norris
`PRODUCTION EDITOR
`Karen Lou Kennedy, RN, ENP
`JOURNAL OPERATIONS
`VICE PRESIDENT;
`ort Wine. taitiana
`
`
`sii Susan M. Gallagher, RN, MSN,9GrowPusiisHer, O/WM, MANAGER
`Sica |Mota RN, MEE ET
`ECPN, WOUNDS
`CNS, CETN
`Mitchellville, Maryland
`Gwen B. Turnbull, RN, BS,
`Jeremy Bowden
`Diane K. Newman, RNC, MSN,
`CEIN
`NATIONAL SALES MANAGER
`CRNP, FAAN
`Sharon A. Aronovitch, PhD,
`Fred Klumpp
`.
`Philadelphia, Pennsylvania
`ne
`Web PRODUCTION MANAGER
`Kimberly B. Chesky
`Liza Ovington, PhD, CWS
`CONTRIBUTING EDrTors
`:
`:
`Prontuccrion DIRECTOR
`Pittsburgh, Pennsylvania
`
`Bonnie Sue Rolstad, RN, BA, CETIN
`Minneapolis, Minnesota
`Manfred S. Rothstein, MD, FACP
`Fayetteville, North Carolina
`Donald E. Saye, DPM, CWS
`‘
`Albuquerque, New Mexico
`Daniel Mark Siegel, MD, MS
`East Setauket, New York
`Keren LSocken, FED
`Baltimore, Maryland
`Laurel Wiersema-Bryant, MSN, RN, CS
`St. Louis, Missouri
`
`
`CHANGE OF ADDRESS
`
`For change of address, mail your old and new addressto:
`eeO/WMSubscriptions
`83 General Warren Boulevard, Suite 100
`Malvern, PA 19355
`or fax to O/WMSubscriptions at:
`(610) 560-0502
`SUBSCRIPTIONS
`U.S. $39.95 for one year. Foreign $59.95
`Single copies and backissues $7.00
`(Foreign add $3.00
`postage)
`Call (610) 560-0500 or (800) 237-7285
`(Mail subscription requests to the address above)
`
`CORPORATE OFFICES
`Business Hours:
`9:00 AM — 5:00 pm EST
`
`HMP Communications
`83 General Warren Boulevard, Suite 100
`Malvern, PA 19355
`Phone: (610) 560-0500 or (800) 237-7285
`Fax: (610) 560-0502
`Email: o-wm@hmpcommunications.com
`
`OstomyWound Management (ISSN 0889-5899) is published monthly by HMP
`Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355; phone
`(800) 237-7285; e-mail o-wm@hmpcommunications.com. Copyright 2002 by HMP
`Communications.All rights reserved. No part ofthis publication may be reproduced,
`stored in a retrieval system, or transmitted in any form or by any means, mechanical, elec-
`tronic, photocopying, recording, or otherwise, without the prior written permission of
`HMP Communications.The editors are solely responsible for selecting content. Although
`the editors take great care to ensure accuracy, HMP Communicationswill notbe liable for
`any errors of omission or inaccuracies in this publication. Opinionsexpressedin articles
`are those of the authors and donotnecessarily reflect those of HMP Communications or
`the editorial advisory board. Advertisements have no influence oneditorial content or
`presentation.
`
`2
`
`—OstomyWound Management
`
`2
`
`

`

`Contemporary topics in skin, wound,
`ostomy, and incontinence care
`
`OstomyWoundManagement
`November 2002, Vol. 48, Issue 11
`
`Features
`
`Departments
`
`Editor’s Opinion
`OnBeing a
`Healing Coach
`
`Foresight
`The Truth about Medical Codes: It’s More Than
`a Bunch of Numbers
`
`The Ostomy Files
`A One-— or Two-Piece Pouching System
`
`MyScope of Practice
`The Challenges of a Nurse/Entrepreneur
`
`AAWC
`
`Information for Authors
`
`Classifieds
`
`Industry News/New Products
`
`Advertisers Index
`
`6 1
`
`0
`
`Re-introducing Honeyin the
`Management of Wounds and
`Ulcers — Theory and Practice
`Peter C. Molan, BSc(Hons), PhD
`
`Topical Hyperbaric Oxygen and
`Electrical Stimulation: Exploring
`Potential Synergy
`Laura E. Edsberg, PhD; Michael S. Brogan,PT,
`MS, CWS; C. David Jaynes, PhD; and Kristin
`Fries, PhD
`
`Ultraviolet Light C in the
`Treatment of Chronic Wounds
`with MRSA:A Case Study
`Thao P. Thai, BScPT, MSc; Pamela E.
`Houghton, BScPT, PhD; David H. Keast, MD,
`CCFP; Karen E. Campbell, RN, MScN, NP;
`and M. Gail Woodbury, BScPT, MSc, PhD
`
`28
`
`42
`
`52
`
`62
`
`Mind-Body Techniques in
`WoundHealing
`Karen A.Wientjes, PT, MPH, CVS
`
`
`
`Right medial lower
`wound after 1 month
`of weekly UVC treat-
`ments. See related story
`on page 52.
`
`4
`
`OstomyWound Management
`
`3
`
`

`

`ULTRAVIOLET LIGHT C IN
`THE TREATMENT OF CHRONIC
`WOUNDS WITH MRSA:
`A CASE STUDY
`
`— Thao P. Thai, BScPT, MSc; Pamela E. Houghton, BScPT, PhD; David H. Keast, MD, CCFP; Karen
`E. Campbell, RN, MScN, NP; and M. Gail Woodbury, BScPT, MSc, PhD
`
`The prevalence of antibiotic-resistant bacteria suchas
`methicillin-resistant Staphylococcus aureus is rapidly
`increasing in healthcare facilities and spreading to the com-
`munity. Methicillin-resistant S. aureus colonize the skin and
`open wounds and can interfere with wound healing. Recent
`studies have shownthatultraviolet light C can kill antibiot-
`ic-resistant strains ofbacteria such as methicillin-resistantS.
`aureus in both laboratory cultures and animaltissue. This
`clinical report describes the effects of ultraviolet light C on
`wound bioburden andclosure in three people with chronic
`ulcers infected with methicillin-resistant S. aureus. Inall
`three patients, ultravioletlight C treatment reduced wound
`bioburden and facilitated wound healing. Two patients had
`complete wound closure following 1 week of ultraviolet light
`C treatment. This case study suggests that ultraviolet light C
`is a promising adjunctive therapy for chronic wounds con-
`taining antibiotic-resistant bacteria such as methicillin-
`resistant S, aureus,
`
`Ostomy/Wound Management 2002;48(11);52—60
`
`worldwide developmentofvirulentbacteria
`
`A«areresistanttomultipleantimicrobial
`
`treatments is occurring.' Onestrain of antibiot-
`ic-resistant bacteria currently receiving attentionis
`methicillin-resistant Staphylococcus aureus (MRSA). In
`many hospitals in the United States and Europe,the
`prevalence of MRSAhasincreased from less than 3%
`in the early 1980sto rates as high as 40% in the 1990s,.~
`* Sincethefirst report of MRSA in Canadain 1981, the
`number of MRSAcases has increased dramatically, and
`cases of community-acquired MRSAalso have been
`documented.** Methicillin-resistant S. aureus bacteria
`colonize the skin and open wounds and mayinterfere
`with woundhealing.”
`Artificially produced ultraviolet light (UVL) was
`introduced as a therapeutic treatment for skin disor-
`ders at the beginning of the 20" century.” Cell culture
`and animal studies that have examined mechanisms by
`which UVL augments woundrepair propose that UVL
`can stimulate cell proliferation,epidermal thickness,”
`blood flow in the cutaneouscapillaries,” and wound
`debridement.” A particular wavelength of UVL of
`between 200 nm and 290 nm called ultravioletlight C
`(UVC) has been shownto have bactericidal effects.”**
`Recent studies indicate that UVC can kill antibiotic-
`resistant strains of bacteria such as MRSAin laboratory
`cells and in animaltissue.” However, whether UVC
`can kill these bacteria when applied to human chronic
`wounds, using suggested clinical protocols, is not
`
`The authorsareaffiliated with the SchoolofPhysical Therapy, Faculty ofHealth Sciences, University of Western Ontario,
`London, Ontario, Canada; and Parkwood Hospital, St. Joseph’s Health Care, London, Ontario, Canada, Please address corre-
`spondence to: Dr. Pamela E. Houghton, Associate Professor, School ofPhysical Therapy, University of Western Ontario, London,
`Ontario, Canada, N6G 1H1; email: phoughto@julian.uwo.ca.
`
`52 OstomyWound Management
`
`4
`
`

`

`known.The purposeofthis case study wasto evaluate
`the potential role of UVC in reducing woundbiobur-
`den and improving woundstatus in chronic ulcers
`infected with MRSA.
`
`Case 1
`A 77-year-old man had multiple leg ulcers due to a
`combination of venous andarterial insufficiency related
`to his previous occupation that involved prolonged stand-
`ing. His long history of venous insufficiency included
`numerouscorrective surgical procedures, including vein
`stripping. He presented with hypertension,bilateral leg
`edema,andsignificantly impaired bilateral lower extremi-
`ty bloodflow with ankle brachial indices (ABI) of 0.53
`and 0.61 of the left and rightleg, respectively. He ambulat-
`ed with a cane and hadlimited mobility and impaired
`muscle pump function in both lower extremities. The
`extreme pain reported bythis patient not only limited his
`mobility, but also caused significant sleep disturbances,
`leading to mild depression. Current medicationsincluded:
`pentoxifylline (400 mgtid), enalapril maleate (2.5 mg
`bid), and acetaminophen (500 mgqid).
`
`Ostomy/Wound Management 2002;48(1 1):52-60
`
`ed as type andrelative amountof bacteria present —
`eg, no growth (0), occasional growth (scant), light
`growth (1+), moderate growth (2+), or heavy growth
`(3+). Other outcome measures included taking pho-
`tographsandassessing changes in wound appearance
`Method
`using the Pressure Sore Status Tool (PSST).” The PSST
`is a pen-and-papertool consisting of 13 domains that
`UVC treatmentprotocol, Using an application tech-
`nique that has been previously described by Nussbaum
`assess the composition of wound bed; woundsize,
`et al," UVC was applied at a distance of 1 inch and per-
`depth, and exudate; and the condition of the periulcer
`pendicular to the wound using premeasured disposable
`skin and wound edge. Scores assigned onascale of 1 to
`spacers. Before treatment, a 254-nm, cold quartz UVC
`5 to each of the individual domains of the PSST are
`generator, approvedfor clinical use in Canada (sup-
`totaled to derive a total score ranging between 13 and
`plied by Medfaxx Inc., Raleigh, NC) was warmed for 5
`65, with 13 representing a completely healed wound.
`minutes before being placed over the wound. The ulcer
`The PSST haspreviously been shownto produce valid
`was cleansed withsterile saline, a thick layer of petrole-
`andreliable assessments of wound appearance.”
`um jelly was applied to the surrounding periulcer skin
`and any healthy granulation tissue, and the wound
`edges were covered with a drape.
`The UVC generator was applied to the woundfor 180
`seconds per woundsite. This length of time is recom-
`mended for the treatmentof infected ulcers*' and was
`selected based on the MRSAkilling rates reported in a
`previousin vitro study.” To shield the eyes from UVC,
`the therapist and patient wore protective goggles. All
`products applied to the patient were sterilized or dis-
`cardedafter a single use. Equipmentthat had to be
`reused was decontaminated using appropriate protocols.
`Subject recruitment. Approvalfor research involving
`human subjects was obtained from appropriate institu-
`tional review boards. The purpose, method,risks, and
`benefits of UVC treatmentwere explained to the
`patients and/ortheir substitute-decision makers and
`informed consent was obtained. Patients included in
`this case series had a chronic ulcer present for at
`least 3 months that was infected with MRSA.By
`definition, an infected woundhasa positive swab
`culture and clinicalsignsofinfection, including:
`marked redness extending beyond the wound
`margins; increased pain; and increased amounts of
`foul smelling, purulent wound exudates. Oral
`antibiotic or topical antimicrobial therapy may or
`maynotbe required.”
`Outcome measures. To determine the magni-
`tude of bacterial burden in woundsforthis case
`study, clinicians used a standardized protocolfor
`administering a semiquantitative swab.”**! The lab
`
`results from the semiquantitative swabare report- earlier pre-clinical study observations: Ultraviolet light C
`
`KEY POINTS
`* Chronic wounds are an importantrisk factor for acquiring
`antibiotic-resistant bacteria that may, in turn, delay healing.
`* The case studies presented here build on and confirm
`
`can kill methicillin-resistant Staphylococcus aureus, as well
`as other non-antibiotic resistant bacteria.
`Given existing treatment limitations, current trends in the
`emergence of antibiotic-resistant bacteria, and the encour-
`aging results reported here, research to ascertain the
`effectiveness of treatments that may help break the cycle
`of antibiotic resistance is long overdue.
`
`November 2002 Vol48 Isuell 53
`
`5
`
`

`

`At his initial wound
`evaluation in July 1998,
`the patient presented
`
`
`SemiquantitativeSwabResults
`
`with a total of six large N+
`
`—*—MRSA —®— Pseudomonas
`
`- © ~ Staph Aureus
`
`_— +
`
`"Scan
`
`superficial ulcers located
`in the medial andlateral
`lowerleg region bilater-
`ally. These ulcers ranged
`in size from approxi-
`mately 1.54 cm’ to 30
`cm’. He reported that the
`ulcers developed follow-
`ing surgery to repair an
`abdominal aneurysm.
`After 2 years of standard wound care and manytopi-
`cal antimicrobial and oral antibiotic treatments,five
`lower extremity wounds remainedin thelateral and
`medial aspect ofthe right lower leg as well as the medi-
`al aspect ofthe left lower leg. Before enrolling in this
`case study, the patient tried oral antibiotics on a recur-
`ring basis (ciprofloxacin in July 1998, November 1998,
`May 1999, June 1999, and August 1999; clarithromycin
`in June 1999 and August 1999). In addition, several dif
`ferent topical antimicrobials were tried, including
`mupirocin (Bactroban’, SmithKline Beecham
`Pharmaceuticals, Mississauga, Ontario, Canada), cadex-
`omeriodine (lodosorb’, Perstorp Pharma, Lund,
`Sweden), and nanocrystalline silver dressings
`(Acticoat”, Westaim Biomedical Corp, Exeter, NH, Fort
`Saskatchewan, Alberta, Canada) in combination with
`mechanical debridement.In general, the patient found
`it difficult to tolerate the application of topical antimi-
`crobials because they exacerbated his pain.
`Atthe time of this study, the patient’s wounds were
`superficial with no undermining and had attached
`edges andloosely adherent slough. Only minimal gran-
`ulation tissue was present. Examination of the dressings
`showed that his wounds were producing copious
`amounts of purulent yellow exudate. Furthermore, sig-
`nificant erythema surrounded the wounds.
`Semiquantitative bacterial cultures obtained before
`treatmentrevealed the presence of three types of bacte-
`ria: methicillin-resistant S. aureus (MRSA)inhis right
`medial lower ulcer and a combination of Pseudomonas
`aeruginosa and S. aureus in his left medial ulcer.
`The wounds were treated with standard wound care
`consisting of saline cleansing, several layers of absorp-
`
`oO
`
`——_— == == oe
`After Single
`UVC Treatment
`
`After 2 weeksof
`seven UVC Treatments
`
`After One Month ofweekly
`UVC Treatments
`
`Figure 1
`Changesin bacterial colonization of lower leg wounds: CaseI.
`
`tive hydrofiber dressing (Acquacel’; Convatec, Skillman,
`NJ), mild compression therapy (Surepress’;Convatec,
`Skillman, NJ), and self-adherent tape (Coban”, 3M,St.
`Paul, Minn.).
`Using the UVC treatmentprotocol described previ-
`ously, the patient received seven UVC treatments over a
`14-day period. Treatment was scheduled to coincide
`with dressing changesonalternate days. This intensive
`2-week treatmentperiod was followed by 1 month of
`weekly UVC treatments. Each woundreceived 180 sec-
`onds of UVCirradiation per treatmentsession. During
`the initial seven UVC treatments, the patient received
`no other antibiotic treatment. However, during the |
`month of weekly UVC treatments, the patient’s stan-
`dard woundcare regimen included a 15-day course of
`ciprofloxacin (500 mgbid) anda trial of sodium chlo-
`ride-impregnated absorbent dressing (Mesalt"; SCA
`Molnlycke, Regensdorf, Switzerland). Use of the sodi-
`um chloride-impregnated absorbent dressing waslater
`discontinued because the subject reported he could not
`tolerate the increased pain that occurred when the
`dressing was applied.
`The two woundsthat were closely monitored were
`the left medial and right medial lower ulcer, which were
`approximately 18.3 cm* and 15.3 cm’in size, respective-
`ly. Results obtained from semiquantitative swabs taken
`from the two lowerleg woundsites showed that heavy
`growth of P. aeruginosa (3+) was completely eradicated
`after the first UVC treatment and no growthofS.
`aureus wasevidentafter 2 weeks ofalternate day UVC
`treatments (see Figure 1). A continuing treatment pro-
`gram of one UVCtreatment per week for 1 month,in
`addition to conventional wound care and antibiotics,
`
`54 OstomyWound Management
`
`6
`
`

`

`
`
`Figure 2a
`Case I: Right medial lower woundafter seven daily UVC
`treatments.
`
`was required to remove MRSA from the woundbed. Of
`note: Both wounds contained a moderate growth (2+)
`of S. aureus.
`In addition to marked changesin the type andrela-
`tive amountof bacteria present within the wound bed,
`improvements in wound appearance were observed
`(see Figures 2a and 2b). After 1 month of UVCtreat-
`ment, the authors observed the presence ofepithelial
`buds, normal skin color surrounding the wound, and
`the emergenceof healthy “beefy” red granulation tissue
`in the right medial lower wound. This improvementin
`woundappearancewasreflected in a reduction of PSST
`scores (see Tables 1 and 2).
`
`Case 2
`A 78-year-old womanhadpoorly controlled type
`2 diabetes for 12 years and lower extremity neuropa-
`thy for 5 years. She also had a decreased lower
`extremity blood flow (ABI < 0.8) and absent pedal
`pulses. Her medical history included: obesity,
`ischemic heart disease,atrial fibrillation, myocardial
`infarct, congestive heart failure, hypertension for 12
`to 15 years, and poor pulmonary function, requiring
`intermittent use of oxygen administered via nasal
`prongs. She was admitted from a nursing home to
`the hospital for chronic pain and immobility, exacer-
`bated by a history of spinal stenosis at L2, L3, and
`L5, with surgery in 1998, and osteoarthritis (OA)
`requiring left knee and bilateral hip replacements.
`She took numerous medications, including aceta-
`minophen 500 mg,twotablets qid, for pain.
`Immobile for 3 months before admission, she had
`developed severe depression and anxiety that were
`
`
`
`Figure 2b
`Case 1: Right medial lower wound after 1 month of weekly
`UVC treatments.
`
`poorly controlled. She presented at the hospital with
`an ulcer located on thefifth toe of her right foot that
`had been present for approximately 3 months before
`admission. A previoustrial of oral antibiotics (lev-
`ofloxacin, 500 mg OD for 7 days), was unsuccessful.
`Standard woundcare consisting of saline cleansing
`and a transparent dressing (Tegaderm”, 3M,St. Paul,
`Minn.), in conjunction with wearing a protective
`boot, had not resulted in wound closure.
`At the time of this study, the right fifth toe ulcer
`was approximately 0.4 cm*. Semiquantitative swab
`cultures indicated that the toe ulcer was colonized
`with MRSA(see Figure 3). Before UVC treatment,
`the wound wassuperficial with no undermining, had
`attached edges, and contained loosely adherent
`slough, with ‘minimal granulation tissue present.
`Examination of the wound dressings revealed that
`the wound was producing a moderate amount of
`serosanguineous exudate.
`Using the UVC treatmentregimen previously
`described, the patient was treated with seven consec-
`utive, daily UVC treatments of 180 secondseach to
`the right fifth toe ulcer. During the UVC treatment
`period, she continued to receive the standard wound
`care described.
`
`The reduction in bacterial bioburden of the ulcer
`(see Table 1) was associated with concurrent wound
`reepithelialization, and the ulcer was healed follow-
`ing 1 week of UVC treatments. This marked
`improvement in woundstatus wasreflected in a
`change of PSST scores from a PSST score of 30 pre-
`UVCtreatmentto a score of 14 post-UVC treatment
`(see Table 2).
`
`November'2002 ‘Vol. 48 Isue11 55
`
`7
`
`

`

`TABLE|
`EFFECTS OF UVC ON WOUNDS WITH MRSA:
`
`SEMIQUANTITATIVE SWAB RESULTS
`
`
`
`
`
`* Wound without MRSA was notincluded:left medial
`
`tained nonadherentyellow slough. The
`wound was approximately 0.6 cm’in size
`(see Figure 4). Semiquantitative swab cul-
`tures indicated that the ulcer contained
`MRSA.Theskin surroundingthe ulcer was
`Following Seven
`Subject Ulcer Location Before UVC
`
`
`
`on Tiesonefita.|UVTreatments. brightred, andhis third toe was swollen. He
`Case I*
`Right medial lower Heavy growth
`Light growth of
`had nonpitting edemaextending > 4 cm
`
`CERO ier)*ABARAT) around the wound, with peripheral tissue
`Case2
`Right 5* toe
`Heavy growth
`_Light growth of
`:
`9
`WEEN
`of MRSA (3+)
`MRSA (1+)
`induration between 2 cm and 4 cm extend-
`Case 3 Light growth of Occasional growth__ing less than 50% around the wound. TheLeft 3% toe
`MRSA (I+)
`of MRSA (scant)
`patient had undergoneantibiotic therapy
`before treatment with UVC consisting of
`tetracycline (250 mg qid) for 10 days.
`However, antibiotic treatment in conjunc-
`tion with standard woundcare consisting of
`saline cleansing and dry gauze dressings was
`
`unsuccessful at achieving woundclosure.
`
`TABLE 2
`WOUND APPEARANCE BEFORE AND
`AFTER UVC TREATMENT
`Using the UVC treatmentprotocol
`Subject Ulcer Location Before UVC
`Following Seven
`
`
`______Treatments UVCTreatments=described, the patient wasgiven daily, 180-
`Right medial lower
`*PSST = 38
`Case |
`*PSST = 29
`second UVCtreatments over a 7-day period.
`Left medial
`*PSST = 39
`*PSST = 31
`During the UVC treatmentperiod, the
`Right 5* toe
`*PSST = 30
`*PSST = 14
`patient continued to receive standard wound
`Left 3% toe
`*PSST = 34
`*PSST = 17
`care and antibiotic therapy (tetracycline, 500
`mg qid) for 10 days. The patient also was
`given vitamin E and acetaminophen.
`Methicillin-resistant S. aureus in this
`wound as determined using semiquantita-
`tive swabs was reduced followinga single
`treatment of UVC and remainedlow after 1 week of
`daily UVC treatments(see Table 1). Following comple-
`tion of the 7-day daily UVC treatment, the ulcer was
`closed with complete woundreepithelialization. This
`improvement in woundstatus wasreflected in a
`marked improvementin PSSTscores(see Table2).
`
`Case 2
`Case 3
`
`*The pressure sore status tool (PSST)is a pencil-and-paper tool for which
`scores are assigned on a scale of 1 to 5for 13 separate domains based on
`the appearance of the wound. Summationofscoresfrom the individual
`domains of the PSSTgives a total PSSTscore between 13 and 65, with 13
`representing a completely healed wound.
`
`Case 3
`Case 3 involves an 81-year-old man, with a medical
`history of Alzheimer’s Disease (5 years), dementia,falls,
`depression, and type 2 diabetes that was well controlled
`with diet. He had a history of developing recurring
`ulcers with infection on the plantar aspect ofhis toes,
`typically lasting months before healing. Contributing
`factors to the developmentofhis toe pressureulcers
`included: repeated pressure from walking more than 6
`hours per day, biomechanical imbalancesin the foot,
`loss of ankle muscle pump due to OAin the knees and
`previousright ankletriple arthrodesis, and bilateral
`lower extremity edema. The subject wasreceiving regu-
`lar chiropody visits for wound debridement on the
`plantar surface ofhisfeet.
`At the timeofthis study, a painful blister on hisleft
`third toe had developed into an open,infected wound
`with purulent yellow drainage. The ulcer was superfi-
`cial with no undermining, had attached edges, and con-
`
`56 OstomyWound Management
`
`Discussion
`Research into alternative nonantibiotic modalitiesis
`necessary to combat the widespread emergence of
`antibiotic-resistant bacteria such as MRSA.Ultraviolet
`light C band with a wavelength of between 200 nm and
`290 nm has been found to have bactericidal effects,
`particularly against antibiotic-resistant bacteria, as
`demonstrated in recent in vitro and in vivo experi-
`ments.”*** This present case study examinedtherole of
`UVC in reducing wound bioburden and improving
`wound status in chronic, MRSA-infected ulcers. Results
`from this case study suggest that UVC treatment can
`
`8
`
`

`

`
`
`Figure 3
`Case 2: Rightfifth toe before UVCtreatments.
`
`
`
`Figure 4
`Case 3: Left third toe before UVC treatments.
`
`decrease the relative amount of MRSA.In all three
`cases, wound bioburden decreased,clinical signs of
`infection diminished, and the wound appearance
`improved as indicated by PSSTscores. In Case 1, UVC
`treatmentresulted in the progression towards wound
`closure as marked by improved epithelialization and
`the presence ofdistinct epithelial buds. In Cases 2 and
`3, full woundclosure was achieved, characterized by
`complete reepithelialization.
`Two clinical studies examinedtheefficacy ofultravi-
`olet light (UVL), which contains type A, B, and C wave-
`lengths, in the treatment of chronic wounds. Wills et
`al* demonstrated in a randomized, controlled study
`that patients with superficial pressure ulcers, some of
`which wereinfected, healed faster when treated with
`UVLthan control subjects receiving standardized
`woundcare only. Nussbaum et al” found that a com-
`bined therapy of ultrasound and UVCwith standard-
`ized woundcare for individuals with pressure ulcers
`resulted in faster healing times than standardized
`wound care combined with laser. The present case
`studyis the first clinical report to documenttheeffects
`of a specific wavelength of UVC treatment on chronic
`ulcers infected with MRSA.
`This case study suggests that previous findings by
`Conner-Kerret al,” indicating that UVC hasbacterici-
`dal effects on MRSA when administered in vitro, can be
`applied to the clinical situation. The killing rates for
`MRSAfor in vitro cultures were reported to be 99.9%
`at 5 seconds and 100%at 90 seconds.” The authors
`
`found that a UVC treatmenttime of 180 seconds was
`required to producesimilar bactericidaleffects in
`chronic wounds. The optimalclinical treatment time
`and length of UVC required for a 100% killing rate of
`
`MRSA in human chronic infected woundsis still
`uncertain. Results presented in this case report suggest
`that although a single 180-second treatment of UVC
`can eliminate MRSA from chronic woundsinitially col-
`onized with light growth (1+) of MRSA, more UVC
`exposure given in subsequent UVC treatments was
`required for ulcers infected with heavy growth (3+) of
`MRSA. Furthermore, several UVC treatments given
`over a 1-month period were required to eliminate
`MRSAfrom woundscolonized with high levels of mul-
`tiple types of bacteria.
`Despite the presence of a low level of MRSA remain-
`ing in the woundsafter the completion of UVCtreat-
`ment, wound appearance markedly improved inall
`three cases and two subjects had complete woundclo-
`sure. According to Dowetal,” the presence of bacteria
`does not always indicate woundinfection. In fact, bac-
`terial infection in woundsis not only determined by
`the number of organisms present in a wound,butis
`also dependenton otherfactors, such as bacteria viru-
`lence and host resistance.”
`In Case 1, before and during UVC treatment, the
`wounds contained an antibiotic-resistant strain of S.
`aureus, MRSA;following UVC treatment protocol,
`these wounds had a moderate level (2+) of S. aureus.
`This apparent change in type of bacteria presentin
`chronic wounds following UVC treatment has been
`observed previously by this research team andalso has
`been reported by others (J. McCulloch, personal com-
`munication). The mechanism for this change in swab
`results from primarily MRSA to S. aureus is uncertain;
`however, it can be postulated that UVC hastheability
`to render MRSA moresusceptible to oral antibiotics.
`The semiquantitative swabis the preferred method
`
`November 2002 Vol. 48 Issue 11 57
`
`9
`
`

`

`ent UVCtreatment schedule on theresults obtained in
`the present study.
`
`Limitations
`Concurrent woundcare therapies, including the uti-
`lization of oral antibiotic therapy and wounddressing
`protocols, were not standardized in this study.
`Furthermore, the woundhistory, primary etiology of
`the wound, and medical history varied greatly between
`subjects and practical issues required the frequency of
`UVCtreatmentsto be tailored to accommodate the
`patient and wounddressing protocol. The influence of
`these factors on the ability of UVC treatment to reduce
`MRSAcolonization of chronic wounds cannot be
`assessed in this case series. An additional limitation of
`the present study is the extremely small sample size.
`Results obtained from these fewindividuals do notsuf-
`ficiently represent the larger population of individuals
`with chronic woundsthat are colonized with MRSA.
`Future work involving a larger sample size is warranted.
`
`for bacterial determination in this case study becauseit
`The individual had a greater pretreatmentbacterial
`bioburden with multiple types ofbacteria, his ulcers
`is economically feasible and easily administered by
`staff. When the swabbing technique is compared with
`were present for an extended duration of time, and he
`
`tissue biopsy, Levine et al* foundalinear relationship had multiple ulcers — all of which were muchlarger
`between the swab andbiopsy counts ofviable bacteria
`than thosein either of the two other cases. Therefore,
`in the same wound:10° organisms by biopsy were
`the authors are unableto assess the influence of differ-
`equal to 10° organisms by swab culture. Herruzo-
`Cabreraet al* concludedin their study that when the
`semiquantitative swab approach wasevaluated,thefol-
`lowing were demonstrated: sensitivity of 97.8%, speci-
`ficity of 86.9%, positive predictive value of 90.7%, and
`a negative predictive value of 96.8%. The researchers
`concluded that semiquantitative cultures are useful for
`surveillance of infection and equivalent to quantitative
`biopsy cultures.
`The three patients described in this case report were
`on-and-off antibiotics numerous times. Two of these
`patients received oral antibiotics during the UVCtreat-
`ments. The prescription oforal antibiotic therapy was
`left to the discretion of the individual’s attending physi-
`cian (not the sameindividualin all three cases). As out-
`lined in a recentarticle by Sibbald etal,” oral antibi-
`otics are not always indicated for chronic wounds with
`localized infection.
`The frequency of UVC treatments administered var-
`ied for the individual cases presented in this report.
`The UVC protocol was changed based on a numberof
`practical issues, including the frequency of dressing
`changes and proximity of the patient to the wound
`treatment center, The patients described in Case 2 and
`Case 3 were both residentsof a local facility and
`received daily dressing changes. Therefore,it was feasi-
`ble to administer daily UVC treatments. The patient
`presented in Case 1 wasliving at home somedistance
`from the woundcenter, and wounddressings, including
`compression wraps, were changedless frequently. For
`this individual, the most feasible treatment protocol
`was UVCtreatments given on alternate daysovera 2-
`week period, followed by weekly UVC treatmentsfor 1
`month. The results showed that individuals who
`received more frequent UVC treatments required only
`1 week of UVC treatments to achieve complete wound
`closure; whereas, the individual who had UVCtreat-
`mentsless often required more than 6 weeks of UVC
`treatment to eradicate MRSA from the wound bed.
`However, manyotherfactors likely contributed to the
`extended UVCtreatment protocol required for Case 1.
`
`Conclusion
`In this case study involving three patients with
`chronic woundslocally infected with MRSA in whom
`previous standard woundcare and topical and oral
`antimicrobial therapy had failed, UVC treatment was
`found to reduce bacterial load andfacilitate healing.
`This case study suggests that UVC is a promising
`adjunctive therapy for chronic woundsinfected with
`antibiotic-resistant bacteria such as MRSA. However,
`only future randomized controlled trials can ascertain
`the efficacy of UVC and determine the optimal treat-
`ment dosage time and length of UVC treatment.
`Additionally, prolonged and repeated exposures to
`ultraviolet light have been associated with an increased
`risk of developing ce

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket