1. Comfort Shield® An Innovative Approach to Incontinence Care

2. Risk Factors for Pressure Ulcer Development
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Risk Factors for Pressure Ulcer Development
Impaired Mobility 87.0%
Fecal Incontinence 56.7%
Malnutrition 54.4%
Decreased Mental Status 50.7%
Peripheral Vascular Disease 28.1%
Urinary Incontinence 27.0%
Diabetes 23.7%
Maklebust J, Magnan MA, Adv Wound Care. Nov 1994;7(6):25, 27-8, 31-4 passim.

3. Risk Factors for Pressure Ulcer Development
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Risk Factors for Pressure Ulcer Development
“…The odds of having a pressure ulcer were 22 times greater for hospitalized adult patients with fecal incontinence compared to hospitalized patients without fecal incontinence…and 37.5 times greater in patients who had both impaired mobility and fecal incontinence”
Emphasize incontinence as two of the top six risk factors for developing pressure ulcers.
JoAnn Maklebust, MSN, RN, CS, NP and Morris A. Magnan, MSN, RN, “Risk Factors Associated with Having a Pressure Ulcer: A Secondary Data Analysis”, Advances in Wound Care, November 1994

4. Facts About Pressure Ulcers
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Facts About Pressure Ulcers
80% of pressure ulcers in hospital are Stage I or Stage II.1
Almost half of all pressure ulcers form on the sacrum (36.9%) and ischium (8.0%).2
A healthcare facility will spend between $400K and $700K annually on pressure ulcer treatment.3
JCAHO lists prevention of health care
associated pressure ulcers as a patient
safety goal.4
Over a boney prominence.5
1. Whittington KT, Briones R, “National Prevalence and Incidence Study: 6-Year Sequential Acute Care Data,” Adv Skin Wound Care Nov/Dec;17(9): Amlung SR, Miller WL, Bosley LM, Adv. Skin Wound Care Nov/Dec; 14(6): Robinson, C; Gioekner, M; Bush, S; Copas, J; et al. Determining the efficacy of a pressure ulcer prevention program by collecting prevalence and incidence data: a unit-based effort. Ostomy Wound Manage May: 49(5):
Joan Junkin, MSN, RN, CWOCN, BryanLGH Medical Center

5. Searching for an Appropriate Name: Incontinence Associated Dermatitis
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Searching for an Appropriate Name: Incontinence Associated Dermatitis
Acknowledges that condition extends
beyond perineal skin.
Clearly identifies UI or FI as primary
causative factor.
Removes negative and unfair association
with diapers.
Broad enough to encompass secondary infections such as candidiasis.
Usually well beyond boney prominence
Gray M, Lerner-Selekof J, Junkin J, A Closer look at Perineal skin injury associated with incontinence in acute care facilities. A CE symposium in conjunction with the 2006 WOCN conference, Minnieapolis, MN June 2006

6. May/June 2007 Multi-Site Prevalence Study- Bryan LGH;
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May/June 2007
Multi-Site Prevalence Study- Bryan LGH;
University of Maryland1
608 patients surveyed
120 patients incontinent
42.5% Perineal skin injury
20.0% had IAD
21.7% had pressure sores
Lerner-Selekof J, Junkin J, Prevalence of Incontinence and Associated Skin Injury in the Acute Care Patient, JWOCN, May/June 2007

7. The Nix Study HIGHLIGHTS
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The Nix Study HIGHLIGHTS
“Use of Skin Protectants is Lacking in Protocols and Application”
The goal was to determine if facility has protocol in place for skin protectant application & the frequency of compliance to that protocol.
76 hospitals & LTC facilities were involved.
While 75% of protocols include the use
of a skin protectant, but the actual USAGE
of those skin protectants is severely lacking.
Only 10 cents per patient per day is being
spent on skin protectants
(barrier creams/ointments).
Nix, D., Ermer-Seltun, J, Ost/wound Mgmt. Dec 2004;50 (12):59-67

8. The Lyder Study HIGHLIGHTS
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The Lyder Study HIGHLIGHTS
“A review of Perineal Skin Care Protocols and Skin Barrier Product Use.”
The goal was to put in place a 3-pronged prevention program to decrease pressure ulcers.
The changes made were with pressure reduction, nutrition, and skin care protectants.
Compliance to the changes was well managed & enforced.
They monitored 136 residents at 2 LTC facilities over a
5-month period.
Overall, they saw 87% and 76% reduction in their pressure ulcer incidence rates.
The average cost for skin care products was about $5 per patient per day.
Lyder CH, Shannon R, Empleo-Frazier O, McGeHee D, White C, Ostomy/Wound Management. Apr 2002;48(4):52-62.

9. Clever et al. - Pressure Ulcer Study
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Clever et al. - Pressure Ulcer Study
“Evaluating the Efficacy of a Uniquely Delivered Skin Protectant and Its Effect on the Formation of Sacral/Buttock Pressure Ulcers”*
Average Monthly Incidence of Sacral/Buttock Pressure Ulcers
Old Standard of Care
7/00 – 3/01
New Standard of Care
5/01 – 7/01
2/02 – 4/02
Old standard of care vs. using Comfort Shield® as preventative in new standard of care
89%
Reduction in Incidence Of sacral/buttock pressure ulcers
0.5%
4.7%
*Comfort Shield® was used on all incontinent patients and was the only variable changed from the control period.
Clever K, Smith G, Bowser C, Monroe K
Long-Term Care Unit, Fulton County Medical Center, McConnellsburg, PA, Ostomy/Wound Management. Dec 2002;48(12):60-7.

10. 4/15/2017
Donna Driver MS, CWOCN Peer-reviewed clinical study published in Critical Care Nurse August 2007
Two Phase Study
Phase 1 Multi-step process
Phase 2 All in one product

11. 4/15/2017
Consistency is the Key for Treating Severe Perineal Dermatitis Due to Incontinence
Sluser S, Sturgeon Community Hospital and Health Centre.
Poster presented at the Clinical Symposium on Advances in Skin and Wound Care, Las Vegas, NV. Oct 2005.

12. 4/15/2017
“The Development of Cost-Effective Quality Care for the Patient with Incontinence”
Group A = Cleansing spray, washcloths, skin barrier
(multi- step process and the current practice).
Group B = Shield Barrier Cloths.
Group C = Disposable washcloth without dimethicone.
Results:
Group A = $6.13 per patient per day; 10% skin breakdown.
Group B = $5.40 per patient per day; 8% skin breakdown.
Group C = Discontinued in week 4 due to 29% skin breakdown.
consults due to IAD and consults due to IAD.
Dieter L, Drolshagen C, Blum K, Cost-effective, quality care for the patient with incontinence. Research Poster Abstract presented at WOCN , Minneapolis, MN June 2006

13. 4/15/2017
“An Economic Evaluation of Four Skin Damage Prevention Regimens in Nursing Home Residents with Incontinence”
By Donna Bliss, Cindy Zehrer, Kay Savik, Graham Smith and Edwin Hedblom
Key Economic Findings:
Total Average Costs
(Per episode – when barrier and cleanser applied every time): $1.17*
Average Cost for Shield Per episode – (all in one barrier and cleanser applied every time): $.90**
*Excludes average per episode supply cost of $.53 for gloves, 2 disposable wipes, 2 cloth washcloths,
1 absorbent pad, 1 brief, 1 underpad
**Based on 3 cloths per episode, $.30 per cloth - Nix
Average Labor Costs (Per episode – when barrier and cleanser applied every time): $.64
Barrier Average (Per episode – applied every time): $0.23
Skin Care Product Costs Average (Per episode – applied every time): $.30
Journal of Wound, Ostomy & Continence Nursing. 34(2): , March/April 2007.
Bliss, Donna Z.; Zehrer, Cindy; Savik, Kay; Smith, Graham; Hedblom, Edwin

14. Getting Started Kit: Prevent Pressure Ulcers
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IHI Protecting 5 Million Lives From Harm
Getting Started Kit: Prevent Pressure Ulcers
How-to-Guide

15. Six Essential Elements of Pressure Ulcer Prevention
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Six Essential Elements of Pressure Ulcer Prevention
Admission Assessment
2. Reassess Daily
Inspect Skin Daily
Manage Moisture
Optimize Nutrition and Hydration
Minimize Pressure

16. 4. Manage Moisture: Keep the Patient Dry and Moisturize Skin
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4. Manage Moisture: Keep the Patient Dry and Moisturize Skin
“By combining routine activities in a protocol such as a “pressure ulcer prevention protocol,” staff can complete multiple tasks while in the room every two hours and document them all at once.”
Provide supplies at the bedside of each at-risk patient who is incontinent. This provides the staff with the supplies that they need to immediately clean, dry, and protect the patient’s skin after each episode of incontinence.
Provide under-pads that pull the moisture away from the skin, and limit the use of disposable briefs or containment garments if at all possible.
Provide pre-moistened, disposable barrier wipes to help cleanse, moisturize, deodorize, and protect patients from perineal dermatitis due to incontinence.

17. Used both Comfort Bath® and Shield Barrier Cloths
“Location, location, location: Getting your incontinence care process bedside Yields reduction in skin injury”- Tory Schmitz, RN,MSN CCRN, CNAA-BC The Methodist Hospital, Houston TX
Used both Comfort Bath® and Shield Barrier Cloths
Placed product at patient bedside
Compliance to appropriate incontinence care increased from 76% to 97%
IAD prevalence dropped from 15% to 0

18. “Location, location, location: Getting your incontinence care process bedside Yields reduction in skin injury”- Tory Schmitz, RN,MSN CCRN, CNAA-BC The Methodist Hospital, Houston TX

19. “Save our skin: Initiative cuts pressure ulcer incidence in half”
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“Save our skin: Initiative cuts pressure ulcer incidence in half”
OSF St Francis – 710 beds, Level 1 Trauma, Magnet, 25,000 admits.
SOS Program: OR Skin Assessment; new skin prevention protocol-Shield Barrier Cloths.
9/ % baseline incidence rate of PS’s.
12/ % incidence rate.
“Premoistened, disposable barrier wipes…..”
Courtney BA, Ruppman JB, Cooper HM, Save our skin: Initiative cuts pressure ulcer incidence in half. Nursing Management.
Apr 2006;37(4):36-45

20. New CMS Guidelines: If It’s Not POA, We Won’t Pay
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New CMS Guidelines: If It’s Not POA, We Won’t Pay
Conditions No Longer Covered:
Pressure Ulcers
Vascular and Urinary Tract Infections from Catheters
Mediastinitis (a SSI from heart surgery)
Falls
“Never Events”
Objects left in body during surgery
Air embolisms
Blood incompatibility
Federal Register, Vol 72, No.162, August 8, 2007

21. What you NEED to Know: MANDATORY POA Tracking: 10/1/07
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What you NEED to Know:
MANDATORY POA Tracking: 10/1/07
Non-Payment: 10/1/2008
What’s “POA?” 48 Hours
According to CMS, what percent of Pressure Ulcers are avoidable?
If POA, Stage III and IV pressure ulcers receive payment
Stage I or II pressure ulcers will not receive payment even if they progress to a Stage III or IV
100%!
Federal Register, Vol 72, No.162, August 8, 2007

22. 4/15/2017
“An Economic Evaluation of Four Skin Damage Prevention Regimens in Nursing Home Residents with Incontinence”
By Donna Bliss, Cindy Zehrer, Kay Savik, Graham Smith and Edwin Hedblom
Key Economic Findings:
Total Average Costs (Per episode – when barrier and cleanser applied every time): $1.17*
Average Cost for Shield Per episode – when barrier and cleanser applied every time): $.90**
*Excludes average per episode supply cost of $.53 for gloves, 2 disposable wipes, 2 cloth washcloths, 1 absorbent pad, 1 brief, 1 underpad
**Based on 3 cloths per episode, $.30 per cloth - Nix
Barrier Average (Per episode – applied every time): $0.23
Skin Care Product Costs Average (Per episode – applied every time): $.30
Average Labor Costs (Per episode – when barrier and cleanser applied every time): $.64

23. Provide the Supplies at the Bedside
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Provide the Supplies at the Bedside

24. Why Comfort Shield Barrier Cloths?
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Why Comfort Shield Barrier Cloths?
One-step process.
Eliminates process variation between caregivers.
Reduces the impact of one of the major risk factors associated with pressure ulcer development which is incontinence.
Evidence-based clinical outcomes.
Less IAD consults
Cost effective: Comfort Shield average cost per day per patient = .29 per cloth x 9 washcloths = $2.64 / vs. traditional incontinence care products at $5.19 per day.

25. $83.6M Sage Medline ConvaTec Smith+Nephew Coloplast Calmoseptine
INCONTINENT OINTMENTS & BARRIERS
Sage
$83.6M
Annual 2011 Market
Medline
ConvaTec
Coloplast
Smith+Nephew
Calmoseptine
others*
42.4%
17.6%
15.8%
8.6%
5.3%
3.3%
<2% each
Source: GHX Trend Report (Dollars) 2nd Quarter, 2011 Hospital; Annual market represents last 4 quarters of data
* others include: Healthpoint, 3M, Fougera, Derma Sciences, etc.

26. $38.2M Sage Shield Barrier Cloths
ALL-IN-ONE PREPACKAGED INCONTINENCE OINTMENTS & BARRIERS
$38.2M
Annual 2011 Market
Sage Shield Barrier Cloths
Medline TPC
92.6%
7.4%
Source: GHX Trend Report (Dollars) 2nd Quarter, 2011 Hospital; Annual market represents last 4 quarters of data

27. Potential Shield Market Current Market Capture: 25%
Market Review - Shield
Potential Shield Market
$113 M
Market Available: 75%
Shield Sales*
$28.5 M
Current Market Capture: 25%
*Source: Inpatient admissions and LOS for US and Canada per 2006 HCUP Nationwide Inpatient Sample (NIS) and 2006 Canadian Institute for Health Information (CIHI). Rates calculated on assumption of 20% of inpatient incontinence (Junkin) with 3 episodes per day, 3 $.31 per cloth. Shield sales figures: Sage Sales from September 2007 – August 2008

28. Who is Focused on Skin Breakdown? CMS State Operations Manual, F314
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Who is Focused on Skin Breakdown? CMS State Operations Manual, F314
“At least daily, staff should remain alert to potential changes in the skin condition and should evaluate and document identified changes. For example, a resident’s complaint about pain or burning at a site where there has been pressure or a nursing assistant’s observation during the resident’s bath that there is a change in skin condition should be reported so that the resident may be evaluated further.”
Centers for Medicare & Medicaid Svcs, CMS Manual System, Pub State Operations, Provider Certification, Appendix PP Guidance to Surveyors for LTC Facilities, F314 §483.25(c) Pressure Sores, Monitoring (Rev. 4, Issued/Effective ). Dept of Health & Human Svcs, Transmittal 12, 14 Oct 2005:145
(available at new.cms.hhs.gov/transmittals/downloads/R12SOM.pdf).

29. Who is Focused on Skin Breakdown? CMS State Operations Manual, F315
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Who is Focused on Skin Breakdown? CMS State Operations Manual, F315
“One key to preventing skin breakdown is to keep the perineal skin clean and dry. Research has shown that a soap and water regimen alone may be less effective in preventing skin breakdown compared with moisture barriers and no-rinse incontinence cleansers.”
Centers for Medicare & Medicaid Svcs, CMS Manual System, Pub State Operations, Provider Certification, Appendix PP Guidance to Surveyors for LTC Facilities, F314 §483.25(c) Pressure Sores (Rev. 4, Issued/Effective ) and F (d) Urinary Incontinence, Skin-Related Complications (Rev.8, Issued/Effective ). Dept of Health & Human Svcs, Transmittal 12, 14 Oct 2005:131,180 (available at new.cms.hhs.gov/transmittals/downloads/R12SOM.pdf).

30. Comfort Shield® Barrier Cloths Replace
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Comfort Shield® Barrier Cloths Replace

31. Thank You For Your Time