Comfort
®
Shield
An Innovative Approach to
Incontinence Care
Risk Factors for Pressure
Ulcer Development
•
•
•
•
•
•
•
Impaired Mobility
Fecal Incontinence
Malnutrition
Decreased Mental Status
Peripheral Vascular Disease
Urinary Incontinence
Diabetes
Maklebust J, Magnan MA, Adv Wound Care. Nov 1994;7(6):25, 27-8, 31-4 passim.
87.0%
56.7%
54.4%
50.7%
28.1%
27.0%
23.7%
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”
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
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.
2004 Nov/Dec;17(9):490-4. 2. Amlung SR, Miller WL, Bosley LM, Adv. Skin Wound Care. 2001 Nov/Dec; 14(6): 297-301. 3.
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. 2003. May: 49(5):44-6. 48-51.
4. http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/07_ltc_npsgs.htm. 5. 
Joan Junkin, MSN, RN, CWOCN,
BryanLGH Medical Center
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
http://www.sageproducts.com/education/shArticles.asp
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
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
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
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.
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 vs.
using Comfort Shield®
as preventative in new
standard of care
4.7%
0.5%
Old Standard of Care
New Standard of Care
7/00 – 3/01
5/01 – 7/01
Reduction in Incidence
Of sacral/buttock pressure
ulcers
2/02 – 4/02
*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.
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
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.
“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.
• 2003 72 consults due to IAD and 2004 10 consults due to IAD.
http://www.sageproducts.com/education/shSymposiaPres.asp
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
“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):143-152, March/April 2007.
Bliss, Donna Z.; Zehrer, Cindy; Savik, Kay; Smith, Graham; Hedblom, Edwin
IHI Protecting
5 Million Lives From Harm
Getting Started Kit:
Prevent Pressure Ulcers
How-to-Guide
http://www.ihi.org/ihi
Six Essential Elements of
Pressure Ulcer Prevention
1.
2.
3.
4.
5.
6.
Admission Assessment
Reassess Daily
Inspect Skin Daily
Manage Moisture
Optimize Nutrition and Hydration
Minimize Pressure
http://www.ihi.org/IHI/Programs/Campaign/
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.
http://www.ihi.org/IHI/Programs/Campaign/
“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
“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
“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.
• 9/2001 9.4% baseline incidence rate of
PS’s.
• 12/2005 1.8% incidence rate.
• “Premoistened, disposable barrier wipes…..”
http://www.sageproducts.com/education/shArticles.asp
Courtney BA, Ruppman JB, Cooper HM, Save our skin: Initiative cuts pressure ulcer incidence in half. Nursing Management.
Apr 2006;37(4):36-45
New CMS Guidelines:
If It’s Not POA, We Won’t Pay
Conditions No Longer Covered:
1. Pressure Ulcers
2. Vascular and Urinary Tract
Infections from Catheters
3. Mediastinitis (a SSI from
heart surgery)
4. Falls
5. “Never Events”
– Objects left in body during
surgery
– Air embolisms
– Blood incompatibility
Federal Register, Vol 72, No.162, August 8, 2007
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? 100%!
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
Federal Register, Vol 72, No.162, August 8, 2007
“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*
Barrier
Average
episode
– applied
every
Average
Cost for(Per
Shield
Per episode
– when
time):
$0.23
barrier
and cleanser applied every time):
$.90**Average (Per
Skin Care Product Costs
*Excludes average per episode supply cost of $.53 for gloves, 2 disposable
episode
– applied every time): $.30
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
http://www.ncbi.nlm.nih.gov/sites/entrez
Provide the Supplies at the Bedside
Why Comfort Shield Barrier Cloths?
1. One-step process.
2. Eliminates process variation between caregivers.
3. Reduces the impact of one of the major risk factors
associated with pressure ulcer development which is
incontinence.
4. Evidence-based clinical outcomes.
5. Less IAD consults
6. 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.
INCONTINENT
OINTMENTS & BARRIERS
45%
40%
Annual 2011 Market
35%
30%
25%
20%
15%
10%
5%
0%
42.4% 17.6% 15.8% 8.6%
* others include: Healthpoint, 3M, Fougera, Derma Sciences, etc.
5.3%
3.3%
<2%
each
Source: GHX Trend Report (Dollars) 2nd Quarter, 2011 Hospital;
Annual market represents last 4 quarters of data
ALL-IN-ONE PREPACKAGED INCONTINENCE
OINTMENTS & BARRIERS
Annual 2011 Market
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
92.6%
7.4%
Source: GHX Trend Report (Dollars) 2nd Quarter, 2011 Hospital;
Annual market represents last 4 quarters of data
Market Review - Shield
Shield Sales*
$28.5 M
Current Market
Capture: 25%
Potential Shield Market
$113 M
Market Available: 75%
*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 cloths @ $.31 per cloth. Shield sales figures: Sage Sales from September 2007 – August 2008
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. 100-07 State Operations, Provider Certification, Appendix PP
Guidance to Surveyors for LTC Facilities, F314 §483.25(c) Pressure Sores, Monitoring (Rev. 4, Issued/Effective 11-12-2004). Dept
of Health & Human Svcs, Transmittal 12, 14 Oct 2005:145
(available at new.cms.hhs.gov/transmittals/downloads/R12SOM.pdf).
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. 100-07 State Operations, Provider Certification, Appendix PP
Guidance to Surveyors for LTC Facilities, F314 §483.25(c) Pressure Sores (Rev. 4, Issued/Effective 11-12-04) and F315 483.25(d)
Urinary Incontinence, Skin-Related Complications (Rev.8, Issued/Effective 06-28-05). Dept of Health & Human Svcs, Transmittal 12,
14 Oct 2005:131,180 (available at new.cms.hhs.gov/transmittals/downloads/R12SOM.pdf).
Comfort Shield® Barrier Cloths Replace
Thank You For Your Time