CLINICAL STUDY - KINERIS CUSHION - HEIGHT 7 CM - TABULATED SUMMARY
ITEM
Product studied
Type of study
Date of study
Objective of the study
DESCRIPTION
Kinéris cushion, height 7 cm
Non-interventional prospective clinical study – observational type
1995
Assessment of the performance of the Kinéris Cushion, height: 7 cm, when caring for
Persons at Risk of Bedsores (PRBs) or Persons Suffering from Bedsores (PSBs)
METHOD
Criteria for inclusion
Context and place of study
Main judgement criterion
Secondary judgement criteria
Sample size
Randomisation method
Method of analysing the results
RESULTS
Number of subjects analysed
Duration of monitoring
Patient characteristics
(without group comparability)
Persons admitted to hospital and presenting a risk of the appearance of bedsores or
suffering from one or more bedsores rated from stages 1 to 3 on the Waterlow scale
Establishments
- Paul Coste Floret Public Hospital Lamalou les Bains (Hérault département), Jeanne
d’Arc Department head of the study: Dr. Garlenq
- Paul Coste Floret Hospital, Lamalou les Bains (Hérault département), Department of
Functional Rehabilitation (RFL) head of the study: Dr. Ginglinger (head physician) Mr.
Delava (Head Physiotherapist)
- Propara Centre Montpellier (Hérault département), MCMK (Moniteur-Cadre en
Masso-Kinésithérapie- Senior Teacher of Massage and Physiotherapy) Department
head of the study: Mr. Reynold (Head Physiotherapist)
- Le Grand Feu Functional Rehabilitation Centre Niort (Deux-Sèvres département),
head of the study: Dr. Servant (deputy chief physician) Ms. Laurens (supervisor)
- Le Grand Feu Functional Rehabilitation Centre Niort (Deux-Sèvres département),
head of the study: Dr. Bellouin (deputy physician) Ms. Lacaud (head supervisor)
- Cap Peyrefitte Medical Centre Cerbère (Rhône département), Functional
Rehabilitation Department head of the study: Dr. Bouffard-Vercelli (head physician)
- Charles Foix Hospital, Ivry sur Seine (Val de Marne département), Orbe Department
head of the study: Dr. S. Meaume (Hospital practitioner)
- La Tour de Glassies Centre Bruges (Gironde département), Functional Rehabilitation
Department head of the study: Dr. N’Guyen (head physician) Ms. Ribes (senior nurse)
- Les Capucins Functional Rehabilitation Centre Angers (Maine-et-Loire département),
Functional Rehabilitation Department head of the study: Dr. Colin (head physician)
Ms. Talha (supervisor)
- Valmante Functional Rehabilitation Centre Marseille (Bouches-du-Rhône
département), Awareness Unit, head of the study: Dr. Scotz (head physician) Ms.
Clenchard (occupational therapist)
Maintaining or improving the person’s skin condition
Healthcare staff to assess the effectiveness and ease of using the support
Patient to assess the comfort provided by the support and the desire to keep it at the
end of the study
N = 60
Not applicable
Descriptive analysis
N = 60
15 days
W / M distribution: 0.62
Average age: 53 years
Average weight: 62 kg
Average height: 1.68 m
21 different pathologies, in particular neurological and traumatological
57% of the population studied consisted of persons with spinal-cord wounds
Hemiplegia, Paraplegia, Tetraplegia, Cranial trauma, Change in general health,
Multiple Sclerosis, Parkinson’s disease, Cardiac insufficiency, Cerebro-vascular
accident, Quadriparesis, Fracture of the neck of the femur, Lumbar osteotomy,
Multiple trauma, Coma, Osteosynthesis, Bed-ridden, Prostate cancer, advanced
dementia, acetabular fracture, Vascular dementia, Loss of independence
PRB:
N = 39 (65%); PSB: N = 21 (35%)
PRB:
36% at risk – Waterlow index ]10-15], 28% at high risk index ]15LA GRANDE ARCHE - PAROI NORD
- 92044 LA DEFENSE CEDEX - France
Tel.:: +33 (0) 1 40 90 33 38 - Fax:
Fax +33 (0)1 40 90 31 01
Website: www.winncare.fr
Characteristics relating to
professional practices
Results inherent in the main
judgement criterion
Results inherent in the secondary
judgement criteria
Secondary effects
20], 36% at very high risk off bedsores – index > 20
Seriousness of bedsores: 62% stage 1 (redness), 38% stage 2 or 3
PSB stage 1 – Redness observed: Pale 27.4%, Bright 36.3%, Very bright 36.3%
PSB stage 2 or 3: 66.6% stage 2 and 33.4% stage 3
carrying out massage
PRB at risk: 28.6% (64.3% “cannot say”)
PRB at high risk: 90.9%
PRB at very high risk 78.6% (14.3% “cannot say”)
PSB stage 1: 100%
PSB stage 2 or 3: 62.5%
Frequency of massage
PRB at risk: 2 / day 75%, 3 / day 25%, more than 3 / day 0%
PRB at high risk: 2 / day 20%, 3 / day 70%, more than 3 / day 10%
PRB at very high risk 2 / day 9.1%, 3 / day 27.3%, more than 3 / day 63.6%
PSB stage 1: data not reported
PSB stage 2 or 3: 2 / day 20%, 3 / day 20%, more than 3 / day 60%
Turning over
PRB at risk: 14.3% (64.3% “cannot say”)
PRB at high risk: 72.7% (18.2% “cannot say”)
PRB at very high risk: 35.7% (28.6% “cannot say”)
PSB stage 1: by state of redness (pale: no, bright and very bright: yes)
PSB stage 2 or 3: 62.5%
Frequency of turning over
PRB at risk: 2 / day 100%, 3 / day 0%, more than 3 / day 0%
PRB at high risk: 2 / day 0%, 3 / day 87.5%, more than 3 / day 12.5%
PRB at very high risk: 2 / day 0%, 3 / day 20%, more than 3 / day 80%
PSB stage 1: data not reported
PSB stage 2 or 3: 2 / day 20%, 3 / day 60%, more than 3 / day 20%
Development of skin condition of PRBs:
No PRB developed bedsores between Day 0 and Day 30
Favourable development 0%, Maintenance of the skin condition 100%
Development of skin condition of PSBs with stage 1:
Redness observed: Pale 85.7%, Bright 14.3%, Very bright 0%
Favourable development 81.8%, Maintenance of skin condition 18.2%, Unfavourable
development 0%
Development of skin condition in PSBs stage 2 or 3:
Seriousness of bedsores: 33.3% stage 1, 33.3% stage 2, 33.3% stage 3
Favourable development 33.4%, maintenance of skin condition 66.6%, Unfavourable
development 0%
Assessment of the support by staff
Ease of use: yes 93.3%, No 0%, cannot say 6.7%
Assessment of results: Excellent 36.7%, Good 50%, Average 3.3%, cannot say 8.3%
Assessment of the support by patients
Comfort: Excellent 41.7%, Good 41.7%, Average 5%, Poor 1.6% cannot say 10%
The patient wishes to keep the pillow: yes 68.3%, No 11.7%, cannot say 20%
None
Bedsore prevention care was given at the same time.
LA GRANDE ARCHE - PAROI NORD
- 92044 LA DEFENSE CEDEX - France
Tel.:: +33 (0) 1 40 90 33 38 - Fax:
Fax +33 (0)1 40 90 31 01
Website: www.winncare.fr
SUMMARY
Development in population of PSBs with stage 1 bedsores
Pale redness
Bright redness
Very bright redness
Initial
assessment
27.4%
36.3%
36.3%
Final
assessment
85.7%
14.3%
0
Development in population of PSBs with bedsores > stage 1
Stage 1
Stage 2
Stage 3
Initial
assessment
0
66.6%
33.4%
Final
assessment
33.3%
33.3%
33.3%
Development of the 5 populations
Population
Favourable development
Stationary state (identity)
Unfavourable development
PRB
N = 39 (65%)
0
100%
0
PSB stage 1
N = 13 (22%)
81.8%
18.2%
0
PPE stage > 1
N = 8 (13%)
33.4%
66.6%
0
The study shows the effectiveness of the Kinéris cushion, height: 7 cm, in preventing seat-induced bedsores in subjects at
risk by Waterlow criteria, and in patients presenting redness or seat-induced stage 2 or 3 bedsores when they are
installed on the cushion.
100% of patients presenting redness on Day 0 saw either a reduction or a total healing of that redness by Day 15.
Patients who presented stage 2 or 3 bedsores saw either a reduction of the bedsore or no development.
Healthcare staff judged the cushion easy to use, also considering that the results were good or excellent in 93.3% of
cases.
The Kinéris cushion, height; 7 cm, was judged very comfortable in 83.4% of cases by patient, and 68.3% of patients who
benefited from it wanted to continue using it.
Abbreviations
PRB:
PSB:
Person(s) at Risk of Bedsores
Person(s) Suffering from Bedsores
LA GRANDE ARCHE - PAROI NORD
- 92044 LA DEFENSE CEDEX - France
Tel.:: +33 (0) 1 40 90 33 38 - Fax:
Fax +33 (0)1 40 90 31 01
Website: www.winncare.fr