English version

Japanese Society of Pressure Ulcers

Department of Gerontological Nursing/
Wound Care Management,
Graduate School of Medicine,
The University of Tokyo

Contents• Overviews– What is DESIGN/DESIGN-R?

P3– When is DESIGN-R used?

P4• Instructions for each score

P5– Depth– Exudate– Size– Inflammation/infection– Granulation tissue– Necrotic tissue– Pocket• References• Appendices

P14
P15

This document was translated into English by Prof. Hiromi Sanada and Dr. Shinji Iizaka (Dept.
Gerontological Nursing/Wound Care Management, Division of Health Sciences and Nursing,
Graduate School of Medicine, the University of Tokyo).
©2014 Japanese Society of Pressure Ulcers. Date of publication 4/1/2014.
No part of this publication may be reproduced, photocopied, or republished in any form, in whole orin part, without permission of the Japanese Society of Pressure Ulcers.
Shunkosha Co.,Ltd.
9th Floor,Shinjuku Lambdax Building,2-4-12 Okubo Shinjuku-ku, Tokyo,169-0072, Japan.
Fax +81-3-5291-2176, E-mail: jokusou@shunkosha.com
2What is DESIGN/DESIGN-R?
Development of DESIGN (2002) 1)•
In 2002, the Scientific Education Committee of the Japanese Society ofPressure Ulcers (JSPU) developed DESIGN as a tool to score the severity ofpressure ulcers and monitor their healing. This tool classifies an ulcer’s
severity based on the necessity of treatment or care.
•
DESIGN is an acronym derived from the six components of the tool: depth,
exudate, size, inflammation/infection, granulation tissue, and necrotic tissue.
P is added to the acronym when a pocket (undermining) is present. Each item
is scored in three to seven grades, and the total score is calculated; a higherscore indicates greater severity.
•
The committee used the consensus method (the nominal group technique) todevelop the tool. The committee comprised a facilitator, one representative
each from the departments of internal medicine, surgery, dermatology, andplastic surgery, and two wound ostomy and continence nurses.
•
The reliability and validity of DESIGN have already been shown. DESIGN is avery useful tool for chronological monitoring of an individual pressure ulcer.
Revision to DESIGN-R (2008) 2)•
With DESIGN, it is difficult to compare the wound healing process between
different pressure ulcers in different patients because of a lack of statisticalweighting of the components. For example, an ulcer with good granulation
tissue may have the same score as an ulcer with a small pocket. Therefore,
revision of the tool was required to accurately distinguish healing rates.
•
First, a large-scale retrospective case series study enrolling 2,598 patients was
conducted, followed by a prospective case series study with 1,003 patients.
For each study, a large number of participants were enrolled in both thehealing and non-healing groups using the Cox hazard analysis.
•
Based on this statistical analysis, we developed a new and validated tool,‘‘DESIGN-R’’, for monitoring wound healing in pressure ulcers (App. 1). The“R” stands for “rating”. Using DESIGN-R, we can compare pressure ulcers not
only in the same patient, but also among different patients hospitalized indifferent wards and hospitals.
•
In 2008, the DESIGN-R tool was published; it has since been widely usedthroughout Japan as a pressure ulcer assessment scale with acceptablepredictive validity.
•
Recently, this tool has been translated into other languages. 3)•
In 2012, the Ministry of Health, Labour and Welfare in Japan introduced
DESIGN-R in the care planning sheet for reimbursement (App. 2).
3

When is DESIGN-R used?
Application:•
DESIGN-R is not used for pressure ulcers during the acute phase, because
wound status is rapidly changing and wounds show many pathologicalmanifestations during the acute phase. DESIGN-R is not suitable for monitoringsuch rapid change.
•
At the chronic phase, DESIGN-R is evaluated once a week or at any time whenwound status changes (e.g., because of debridement or surgery).
Objectives:•
DESIGN-R is used for two purposes: 1) to score the severity of pressure ulcers
and 2) to monitor the healing process.
1) Evaluation of severity 2)•
The severity of each item is classified as “slight”, indicated by lower-case letters,
or “serious”, indicated by upper-case letters. A wound’s status, therefore, can bequickly determined by this unique lettering system. For example, if the depth,
size, and degree of necrosis are classified as serious and a pocket is present, thewound will be described as “D-eSigNP”.
•
The guidelines from the Japanese Society of Pressure Ulcers recommend topicaltreatment and care based on the DESIGN-R severity classification (App. 3). 4)
2) Monitoring healing 5,6)•

Six of the DESIGN components (depth was excluded) were weighted according
to their relationship to the healing rate, and their scores can be summed tocreate a total DESIGN-R score, which ranges from 0 (healed) to 66 (greatest
severity).

•

The predictive validity of the DESIGN-R total score and of weekly changes in thisscore were verified (App. 4).

41) Depth: initial assessment••

Depth is measured at the deepest point of the wound bed. If depth cannot be
determined, the score is “unstageable”.
The depth score is determined based on the gap between the wound bed and thewound edge as well as the type of tissue at the wound bed.

* IMPORTANT--THE DEPTH SCORE IS NOT INCLUDED IN THE TOTAL SCORE.

e.g.,

d0
No particularskin legion andno redness

d1
Persistentrednessd2
Lesion extends
to dermis

Intact skin

Erythema, but
without skinbreakdown

No gap between
wound bed
and edge

D3
Lesion extends
into thesubcutaneous tissue

D4
Lesion extends
to the muscle,
tendon, and bone

D5
Lesion extends
into the articularor body cavity

DU
Impossible tomeasure depth

Necrotic tissue infatty layer with gap
between bed andedge

Necrotic tissue
in muscle fascia

Exposed tendon
with tunnel toankle joint

Covered bynecrotic tissue

Epidermis
DermisFat
MuscleBone51) Depth: healing process••

When the wound improves and becomes shallow, the score is changed incorrespondence with the depth.
The healing process is determined by the degree of the gap between thewound bed and edge.

e.g.,

d0
No particularskin legion andno redness

d2
Lesion extends
to dermis

Healing

The gap between bed
and edge mostly
disappears.
Epithelialization begins* IMPORTANT—
d1 IS NOT INCLUDED DURING THE
HEALING PROCESS.

Epidermis
DermisFat
MuscleBone
Healing process
D3
Lesion extends
into thesubcutaneous
tissueD4
Lesion extends
to the muscle,
tendon, and bone

Increased granulation
tissue in wound bed,
but the gap between
bed and edge remains

Necrotic tissue(white color) oftendon inwound bed

D5
Lesion extends
into the articularor body cavity

DU
Impossible tomeasure depth62) Exudate•••

The exudate level is evaluated based on the amount absorbed by the
dressings or gauze.
If dressing changes are performed once a day, but exudate is excessively
leaked, the score is assessed as E6 (twice a day).
If dressing changes are performed twice a day, but there is only a little
exudate, the score is assessed as e3 (once a day).

73) Size•••

Size should be measured at the determined position (e.g., the right lateralposition) every time.
This score includes the visible surface of the wound and excludes the pocket.
Size is calculated by multiplying the longest wound measurement (length) andthe longest measurement perpendicular to this axis (width).
Measuring the area of skin injury
The longest measurement in wound
and the longest measurement
perpendicular to this axis.

a

a

b

b

a × b

8

4) Inflammation/infection••

Inflammation represents the response of a tissue to the physical stimulation
caused by necrotic tissue, visible as redness around the wound, swelling, heat,and pain.
Infection is a symptom caused by bacteria invading the body and growing up.
Infection is typically accompanied by pus, a foul smell, and fever. Do not use
the results of bacterial tests to score.

i1 Signs of inflammation(fever, redness, swelling andpain around wound)

I3 Clear signs of local infection(inflammation, pus and foul smell)

I9 Systemic impact,
such as fever

Redness and swelling are
observed around wound

Pus is discharged fromundermining

Osteomyelitis is suspectedwith high fever up to 39℃95) Granulation tissue••

Granulation tissue is classified as healthy or unhealthy.
The score is then determined by the proportion of healthy granulation tissue.
g: Healthy granulation tissue

G: Unhealthy granulation tissue

Bright red color andproper moist environment

Proper moist environment,
but edematous tissue

Dark-red tissueg0
Granulation cannot be assessed
because the wound is healed or
too shallow

g1
Healthy granulation tissue
occupies 90% or more

Whitish tissue
g3
Healthy granulation tissue
occupies 50% or more, butless than 90%

Damage to dermis

Healthy granulation
tissue occupies 100%of wound surface

Healthy granulation
tissue occupies 70%
of wound surface

G4
Healthy granulation tissue
occupies 10% or more,
but less than 50%

G5
Healthy granulation tissue
occupies less than 10%

G6
No healthy granulation
tissue exists

Healthy granulation
tissue occupies 40%
of wound surface

Granulation tissue isincreasing beneaththe necrotic tissue

Whitish tissue
over whole surface106) Necrotic tissue••

Necrotic tissue is classified by the type, color and hardness.
If necrotic tissue and non-necrotic tissue are mixed, the dominating tissue
should be evaluated
N6
Hard and thick necrotic
tissue is attached to the
wound

N3
Soft necrotic tissue exists

Necrotic tissue covers
entire wound surface,but can be pinched bytweezers

Softened and loose
necrotic tissue

Fibril-like
necrotic tissue

Necrotic tissue ofdermisBlack anddried tissue

Auto-debrided
necrotic tissue117) Pocket (undermining)•••

The score is determined by the measured pocket area (the longest length [cm]× width [cm]). Specifically, the pocket area is obtained by subtracting theulcer area (c × d) from the entire affected area (including the pocket) (a × b).
Pocket area should be measured in the determined position every time.
The pocket area is checked using a soft tube (P-light), tweezers, or a swab.
The area obtained by subtracting the ulcer area (c×d)
from the entire affected area, including pocket (a×b)

acbdArea ofundermining
Pocket area = a × b － c × d
a: the longest length including undermining
b: the longest width including undermining, perpendicular to the length (a)c: the longest length without undermining
d: the longest width without undermining, perpendicular to the length (c)The pocket area is marked after wound cleansing. The P-light is a safe device to measure
the pocket area by a soft tube with transmitting light. This device prevents further
expansion of the pocket caused by the measurement.
12

Examples of DESIGN-R scoring••••

The DESIGN-R score is expressed as D4 - E6 s12 I9 G5 N3 p0: 35.
Add a hyphen between the depth score and the exudate score to distinguish thedepth score from the other subscores used for the total score calculation.
In accordance with the scoring table, the severity of each item is classified as“slight”, indicated by lower-case letters, or “serious”, indicated by upper-case letters.
Six of the components (excluding depth) were weighted based on their relationshipto the healing rate; these items are summed to create the total DESIGN-R score.

Sacrum ulcer
Depth : Extending to fascia D
Exudate : Dressing change twice a day E
Size : 72 s
Infection : Yes I
Granulation : Less than 50% G
Necrosis : Yes N
Pocket : No p

D-E s I G N

D4 - E6 s12 I9 G5 N3 p0 : 35
Sacrum ulcer
Depth : Lesion extends into
the subcutaneous tissue D
Exudate : Dressing change once a day e
Size : 4-16 s
Infection : No i
Granulation : More than 50% g
Necrosis : No n

D-e s i g n P

Pocket : Yes P

D3 - e3 s6 i0 g1 n0 P24 : 34
13

References
1.

Sanada H, Moriguchi T, Miyachi Y, Ohura T, Nakajo T, Tokunaga K, Fukui M,
Sugama J, Kitagawa A. Reliability and validity of DESIGN, a tool that classifies
pressure ulcer severity and monitors healing. J Wound Care. 2004;1:13–8.

2.

Matsui Y, Furue M, Sanada H, Tachibana T, Nakayama T, Sugama J, Furuta K,
Tachi M, Tokunaga K, Miyachi Y. Development of the DESIGN-R with anobservational study: an absolute evaluation tool for monitoring pressure ulcer
wound healing. Wound Repair Regen. 2011;19:309-15.

3.

Zhong X, Nagase T, Huang L, Kaitani T, Iizaka S, Yamamoto Y, Kanazawa T,
Sanada H. Reliability and validity of the Chinese version of DESIGN-R, anassessment instrument for pressure ulcers. Ostomy Wound Manage.
2013;5:36-43.

4.

The Japanese Society of Pressure Ulcers Guideline Revision Committee. JSPU
guidelines for the prevention and management of pressure ulcers (3rd Ed.).
Jpn J PU. 2014; 16: 12-90.
Available at: http://www.jspu.org/eng/special.html

5.

Sanada H, Iizaka S, Matsui Y, Furue M, Tachibana T, Nakayama T, Sugama J,
Furuta K, Tachi M, Tokunaga K, Miyachi Y. Clinical wound assessment using
DESIGN-R total score can predict pressure ulcer healing: Pooled analysis fromtwo multicentre cohort studies. Wound Repair Regen. 2011;19:559-67.

6.

Iizaka S, Sanada H, Matsui Y, Furue M, Tachibana T, Nakayama T, Sugama J,
Furuta K, Tachi M, Tokunaga K, Miyachi Y; Scientific Education Committee of
the Japanese Society of Pressure Ulcers. Predictive validity of weekly
monitoring of wound status using DESIGN-R score change for pressure ulcer
healing: a multicenter prospective cohort study. Wound Repair Regen.
2012;20:473-81.

14

App. 1. DESIGN-R
Depth: this should be measured at the deepest point of the wound. If the wound becomes shallower,
the decreased depth should be reflected in the assessment
3 Lesion extends into the subcutaneous tissue

0 No particular skin lesion and no redness
d1 Persistent rednessD

2 Lesion extends into dermis

4 Lesion extends to muscle, tendon and bone
5 Lesion extends into the articular or body cavity
U It is impossible to measure the depth

Exudate: amount0 None1 Slight: does not require daily dressing change
3 Moderate: requires daily dressing change
Size: the area of a skin injury (length × width).
0 None3 Smaller than 4cm2
6 4cm2or larger, but smaller than 16cm2s
8 16cm2or larger, but smaller than 36cm2
9 36cm2or larger, but smaller than 64cm2
12 64cm2or larger, but smaller than 100cm2
Inflammation/Infection:eE

6 Heavy: requires dressing change more than twice a dayS

15 100cm2or larger

0 NoneiSigns of inflammation (fever, redness, swelling, andpain around the wound)
Granulation tissue: percentage of healthy granulation
Granulation cannot be assessed because the wound is0
healed or too shallow

3I

9 Systemic impact, such as fever

1g

1 Healthy granulation tissue occupies 90% or more

Clear signs of local infection(eg, inflammation, pus and foul smell)

4
G

Healthy granulation tissue occupies 10% or more, but lessthan 50%

5 Healthy granulation tissue occupies less than 10%

Healthy granulation tissue occupies 50% or more, but
6 No healthy granulation tissue exists
less than 90%
Necrotic tissue: when necrotic and non-necrotic tissues are mixed, the dominating condition should be used for assessment
3 Soft necrotic tissue exists
n 0 NoneN
6 Hard and thick necrotic tissue is attached to the wound
Pocket: the area obtained by subtracting the ulcer from the entire affected area, including the pocket
3p0 NoneP

6 Smaller than 4cm2
9 4cm2or larger, but smaller than 16cm2
12 16cm2or larger, but smaller than 36cm2
24 36cm2or larger

15

App. 2. Care plan sheet in Japan
Name
Birthday//(M / F)yrs old)(

0 Date of care planning
/
/
0
0
0

Wards
Doctor’s name
Nurse’s namePressure ulcers
1. Current: NO / YES (Sacrum, Ischial tuberosity, Coccyx, iliac bone, Greater trochanter, heel, others ((Date of development//))
2. Past:NO / YES (Sacrum, Ischial tuberosity, Coccyx, iliac bone, Greater trochanter, heel, others (J(1,2) A(1,2) B(1,2) C(1,2)‫‏‬

Mobility (Position change by oneself on the bed)‫‏‬(Maintenance of posture or pressure relief in the chair)‫‏‬Morbid Bony Prominence
Joint contracture

Possible Impossible Establish andpractice care
Possible Impossible
plan if patients
fulfil one or
No Yesmore
No YesNo

Yes

Moisture (excessive sweating, urinary or fecal incontinence)‫‏‬

No

Yes

Edema (except for local area)

No

Yes

(0)

(1)

(2)

(3)

(4)

(5)

(U)

Exudate

(0)

(1)

(3)

(6)

Size

(0)

(3)

(6)

(8)

(9)

(12)

(15)

Inflammation/Infection

(0)

(1)

(3)

(9)

Granulation tissue

(0)

(1)

(3)

(4)

(5)

(6)

Necrotic tissue

(0)

(3)

(6)

Pocket

(0)

(6)

(9)

(12)

(24)

Evaluation points

Care plan

Management

Malnutrition

Depth

Relief of pressure and shear force(position change protocol,
support surfaces,
head elevation, posture
maintenance in wheel-chair,etc)‫‏‬))

sum

PU status (DESIGN-R)

Risk assessment of PU

Degree of Independence))Contents of plan
On the bed
In the chair

Skin care
Improvement of nutritional status
Rehabilitation
Developed by Ministry of Health, Labour and Welfare, Japan.
Degree of independence: J (Independent), A (Needing support for going out), B (chair-bound), C (bed-bound).

16

App. 3. Recommendation for topical treatments

Necrotic
tissue(N to n)Inflammation/infection(I to i)ExudateGranulation
tissue(G to g)(E to e)Cadexomer-iodine

Pocket(S to s)(P to p)

Aluminium chlorohydroxy allantoinate

Silver sulfadiazine
Dextranomer

Size

Lysozyme hydrochloride
Zinc oxide

Dextranomer

Trafermin

TopicalAgentsTretinoin tocoferil
Bromelain

Isopropylazulene

Iodine form gauze

Bucladesine sodium

Povidone-iodine

Alprostadil alfadex

Tretinoin tocoferil

Povidone-iodine sugar
Hemolyzed bloodof young calves

Fradiomycin
sulfate-trypsin

Silver+

Alginate

Siver+

Chitin membrane
Hydrocolloid(a little exudate)Dressings

HydrogelHydrogelHydrofiber®

Silver+Silver+Silver+Reconstructive
surgery

Surgical incision

Hydropolymer
Polyurethane foam/soft silicone

Surgery

Surgical debridement

Negative pressure wound therapy
Near-infrared
therapy

PhysioTherapy

Ultrasonictherapy
Hydrotherapy

Electromagnetic
therapy
Electricalstimulation

Pulsatile lavage
with suction

Cleansing/
Disinfection

Antiseptics(clearly infected)

Skin emollients tothe peripheral skin

Cleansing with a mildly acidic cleansing agent

Cleansing inpocketSufficient quantities of isotonic saline or tap water

JSPU Guidelines for the Prevention and Management of Pressure
Ulcers (3rd Ed.)

Recommendation
B

Recommendation
C1

Recommended
because supported
by some evidence

May be considered
because supported
by limited evidence
17App. 4. Predictive validity of DESIGN-R

Evaluation of severity
D

E, S, I, G, N, P
Total score

Superficial

Deep

mild

moderate

Severe

d1-d2

D3-DU

9 or less10-18

19 or more

•Prediction of healing•Selecting appropriate treatment

MonitoringdD
Not
improved

Improved

Not
improved

Improved

After

Score change

After

Score change

1 wk

1 or more increase

1-2 wks

1 or less decrease

2~3 wks 2 or more increase

3 wks

3 or less decrease

4 wks

4 wks

2 or less decrease

3 or more increase•Reconsidering care plan

Sanada H et al. Wound Repair Regen. 2011;19:559-67.
Iizaka S et al. Wound Repair Regen. 2012;20:473-81.

18