Post on 11-Jun-2020
STEP OUT OF INFECTION
• DESIGNED TO
Clean and deslough infected wounds
& initiate the healing process using biological means
• MARKET SEGMENT
Healthcare professionals avoiding use of silver based products
• CLASSIFICATION
Medical device class III
KEY PROPERTIES
• Venous, diabetic and pressure ulcers
• Traumatic and surgical wounds
• Infected wounds or wounds at risk of infection
• Wounds with moderate- to- high levels of exudate
• Sorelex is not indicated for dry wounds
INDICATION
BIOCTHA® ACTIVE LAYER
ACTIVE LAYER
Specially processed combination
of OCTENIDINE AND HYALURONIC
ACID, having both antimicrobial
and biological effect
TRANSMISSION LAYER
Absorbs and leads the excessive
exudate out of the wound
into a secondary dressing
DESLOUGH LAYER
Attracts wound slough which is
removed during wound redressing
€
PRODUCT DESIGN
• Creates a gell in contact with the wound exudate
• Keeps the wound in the moist environment
• Gently sticks to the wound bed and thus perfectly copies
shape of the wound
ACTIVE LAYERFAVORABLE EFFECT ON THE WOUND BED
BIOLOGICAL EFFECT OF SODIUM HYALURONATE
• Substance natural to human body, component of ECM
• Regulates inflammation and sets up correct healing
processes
• Creates natural, moist environment favorable for migration
and proliferation of skin cells
ACTIVE LAYER
• Broad spectrum of antimicrobial efficacy against
Gram-positive and Gram-negative bacteria and fungi.
• Not absorbed into systemic circulation
• Low cytotoxicity to fibroblasts and other cells
ANTIMICROBIAL EFFECT OF OCTENIDINE
ACTIVE LAYER
Clinical trial
Open Labelled, Multicentre Study in Patients with Chronic, Infected
Wounds
Length of the study
6 weeks
Number of dressing changes
3x per week
Average wound duration 103 wks
Wounds enroled in the study
Diabetic ulcer 6
Leg ulcer 36
Mixed ethiology 5
TOTAL NO. 47
Clinical trial
OBJECTIVES OF THE STUDY
Wound dimension changes
Signs of infection
Changes in wound bed tissue
Changes in exudate level
Overall opinion of investigators on Sorelex
AVERAGE WOUND SURFACE
at screening
31,14 cm2
AVERAGE WOUND SURFACE
at final visit
15,19 cm282,1%
70,7% 64,6% 63,6%48,8%
0,0%
20,0%
40,0%
60,0%
80,0%
100,0%
120,0%
WK 1 WK2 WK 3 WK 4 WK 5 WK 6
Clinical trial resultsWOUND DIMENSION CHANGES
Clinical trial - RESULTS
38 % patients with visible signsof infection(bleeding tissue, malodour, pocketing, bridging, abscess, local heat, etc)
No wound deterioration due to theinfection in patients without visiblesigns of infection
100%
80%
60%
40% 40%
20%
0%wk 0 wk 1 wk 2 wk 3 wk 4 wk 5 wk 6
CHANGES IN VISIBLE SIGNS
OF INFECTION
Clinical trial resultsCHANGES IN WOUND BED TISSUE
0,0%
20,0%
40,0%
60,0%
80,0%
100,0%
WK1 WK 2 WK3 WK4 WK5 WK6
Decrease in sloughy
and necrotic tissue
Clinical trial resultsCHANGES IN WOUND BED TISSUE
7,0%
18,1% 17,1%
22,2%
25,3%
33,3%
0,0%
5,0%
10,0%
15,0%
20,0%
25,0%
30,0%
35,0%
WK1 WK 2 WK3 WK4 WK5 WK6
Increase in
epithelial tissue
8 %
49 %
43 %
0,0%
screening
none low moderate high
47 %
47 %
6 % 0,0%
week 6
none low moderate high
Clinical trial resultsCHANGES IN EXUDATE LEVELS
Clinical trial - RESULTSOVERALL RESPONSE TO SORELEX IN COMPARISON WITH PREVIOUS TREATMENT
RESPONSE TO PREVIOUS TREATMENT
RESPONSE TO SORELEX
SIGNIFICANT
IMPROVEMENT
IMPROVEMENT NO CHANGE WORSENING
WORSENING 6 3 2 1 0
NO CHANGE 17 8 6 3 0
IMPROVEMENT 24 17 7 0
Previous treatment: Acticoat, Actisorb Plus, Cutimed Sorbact, Dermacyn, Mepilex Ag,
Aquacel Ag, Nugel, Inadine, Tender Wet, Mepitel, silver alginates, PHMB, PVP.
Clinical trial - RESULTS
SUBJECTIVE EVALUATION OF SORELEX MADE BY INVESTIGATORS
WOUND HEALING EFFECT (1- no wound healing, 8 - extreemly good)
SPEED OF THE HEALING (1- extreemly slow, 8 - extreemly fast)
BENEFICIAL EFFECT IN GENERAL
(1-extreemly low, 8 – extreemly high)
6,1
6,0
6,3
STEP OUT OF INFECTION
• Broad spectrum of antimicrobial activity
• Biactive support of the healing process
• Safe and friendly for skin cells