Evaluation of Decontamination Solutions

Evaluation of comparative data on eye/skin
chemical splash decontamination solutions:
effects on burn severity and healing

Laurence Mathieu, PhD.
Scientific Manager

September 2006, ACS, San Francisco, CA,USA slide 1 PREVOR Laboratory

Our job: Chemical Risk
“Prevent and save”

Health and care
– Active washing solutions for chemical splashes,
– Improvement of care for burnt victims

Environment
– Active absorbent for chemical spills

Edition
– “Chemical risk and occupational health”
– “Solvents”
– “MSDS” (AFNOR ed.)

Training sessions


Outline of the presentation
The chemical burn
- What is Diphoterine®?
- Mechanism
- Innocuousness

- Management of chemical splashes in industries
- Clinical data in industries

- Experimental proofs
- In vitro data
- Ex vivo / In vivo data

- Management of chemical burns
- Clinical study of ocular burns in Martinique
- Case report of a severe ocular burn
- Case report due to an acid cutaneous splash


Which chemicals
produce chemical burns?

Corrosives and irritants:
– acids, bases, oxidizers, reducing agents,
solvents

– or in other words, about 25 000 chemicals

It is important to note: a corrosive or an
irritant can be toxic as well as noxious !


The chemical burn
- Mechanism
- Innocuousness


- In vitro data



What is Diphoterine®?
An aqueous solution containing the fundamental
properties of water
washing of all the chemical families
the effect of pulling the chemical aggressor away from the
surface of the tissues

An amphoteric solution
acts on acids as well as bases, and rapidly restores the eye
and/or skin’s physiological pH

A hypertonic solution
stops the penetration of corrosive chemicals into the tissues
creating a flux from the inside to the outside of the tissues


Mechanism

Diphoterine® is a multisite molecule


- Medical device: Europe, Canada, Australia, Brazil

Mathieu L. Accepted for publication in J Toxicol -- Cutaneous and Ocular Toxicology


Mathieu L. Accepted for publication in J Toxicol -- Cutaneous and Ocular Toxicology


The chemical burn
- Mechanism
- Innocuousness


- In vitro data


Clinical results : Case reports
year Number Firm / country Exposure Body surface
of cases
1999 1 Knoll AG Germany 96% sulfuric acid cheek

1998 1 Giesecke&Debrient 100% nitric acid hand
Germany
1995 1 Metaleurop 96% sulfuric acid Face + neck
Germany
1993 1 Mewa Germany 50% soda Forearm

1991 1 Alusuisse France Soda flakes* Left eye

1991 2 Orgachim France 98% sulfuric acid Face + neck +
shoulders,
(idem + legs)

Immediate decontamination with Diphoterine®, no burn appeared,
no sequelae, no need of secondary care, no loss of work


Clinical results : comparative study
INRS
(French National Institute of Research and Safety)

Comparative study between REDUCED THE
Diphoterine® and water SERIOUSNESS OF
washing in 73 firms about THE ACCIDENTS
145 chemical splashes STOPPED THE PAIN

Falcy M et al. DMT, 53, 1993, 33-41 and DMT, 70, 1997


Clinical results of 42 cases of chemical splashes
Martinswerk, Germany, 1991-1993

washing Diphoterine® acetic acid water
Sick leave 0.18d ±0.4 2.91d ± 4.3 8d ± 8.12
No care 100% ±15 0% ±15 0% ±15
Basic care 0% ±15 80% ±15 25% ± 15
Medical care 0% ± 15 20% ± 15 75% ± 15

Chemical product: soda (40-600 g/l)
Protocol: On site washing

Results:
Variability of the effectiveness of water washing
Significant improvement with Diphoterine® washing

Hall AH et al. Vet Hum Toxicology 2002, 44, 4, 228-231


Study on 375 cases
at ATOFINA, France, 2000

washing water Diphoterine p
Sick leave 7 (3.4%) 0 (0%) < 0.05
Without sick leave 198 170
Without follow-up* 68(52%) 88(33%) <0.05
With follow-up 137 82
*The criterion without follow-up corresponds to no care
Chemicals: Acrylates, sulfuric acid (98%),
Oleum, soda (22%), Diethylaminoacrylate (ADAME)

Results: Significant difference in sick leave,
as well as in the necessity of secondary care
Hall AH et al. Vet Hum Toxicology 2002, 44, 4, 228-231

The chemical burn
- Mechanism
- Innocuousness


- In vitro data


Diphoterine®: In vitro effects
by simple dosage of corrosives
Dosage of 1ml of normal soda & 1 ml of normal
HCL by Diphotérine versus water
14

12 water
10
Diphoterine
8
physiological pH area
pH

6 Diphoterine
4

2
water
0
0 10 20 30 40 50 60
Volume (ml)

Mathieu L et al Toxicology Letters 2002, supplement 1/135, 290, S148


Simulation of a complete washing

washing solution
Flow :150ml/min
Internal pH

External pH

25ml
NaCl 0.9% 50 ml of corrosive
product

Evacuation tube

semi-permeable
membrane

Magnetic
stirrings

Mathieu L et al Toxicology Letters 2002, supplement 1/135, 290, S148



Rinsing of 50 ml soda 1N / 25 ml 0.9% NaCl
with a flow of 150ml/min
Simulation of a
eau 3 min
water 3 min
complete washing
14 0.9% NaCl 3 min
NaCl 0.9% 3min
13 Internal pH of the compartment 2.34%2.34% 3 min
NaCl NaCl 3min
Diphoterine 3 min
dipho 3min
12 physiological pH
pH physio
Influence of amphoter
pH

11
Influence of osmolarity
10

9

8
0 60 120 180 240 300 360
time (min)
graphe 4

Josset P, Meyer MC, Blomet J.SMT 1986, 85, 25-33


The chemical burn
- Mechanism
- Innocuousness


- In vitro data


In vivo comparative study
Saline solution versus Diphoterine®
18 rabbit eyes
pHmeter probe in the anterior chamber
0.01 ml of 15.3 % ammonia during 1 min of contact
pH measurements every 5 seconds
250 ml of saline solution versus Diphotérine®
Histology of the cornea
Diphotérine®: inflexion of pH curve = decrease of pH
3 pH

2.5
Saline solution PCA = 15.9
2

1.5 PCA = 36.8

1
Gérard M, Josset P, Louis V, Ménérath JM, Blomet J, 0.5
Merle H. Existe-il un délai pour le lavage oculaire PCA = 20.3
0
externe dans le traitement d’une brûlure oculaire par Diphotérine®
l’ammoniaque ? Comparaison de deux solutions de - 0.5 No rinsing
Time (mn)
lavage : sérum physiologique et Diphotérine*. J Fr -1
4.1

5.2

7.4

8.5
Ophtalmol 2000 ; 5 : 449-458.
0.05

2.25

3.35

4.45

5.55

7.05

8.15

9.25

10
10.35

11.1
6.3
0.4

1.15

3

Cornea burnt by ammonia
washing after 3 min of contact

By saline solution:
- Coagulated epithelium,
- edematous stroma

By Diphotérine® :
- Vacuolisated and coagulated
epithelium,
- Normal stroma


Experimental in vivo,
prospective, randomized, blind
study of a cutaneous burn
due to concentrated hydrochloric acid

Cavallini M, Casati A. European Journal of
Anaesthesiology 2004, 21, 389-392

Cavallini M, de Broccard F, Corsi MM, Fassati LR,
Baruffaldi Preis FW. Annals of burns and fire
disasters 2004, XVII, 2, 1-5


Skin study in rats
(concentrated HCl burn)
Saline solution versus Diphoterine®
Significant statistical results in favour of Diphoterine®

Decrease of inflammation
(IL-6 à 48h, p < 0.01; à 7 days, p < 0.05)

Decrease in pain
(substance P within 48h, p < 0.05; β-endorphin at 7 days, p<0.05)

Decrease in the size of the lesions
(no washing : 12mm; saline solution : 6 mm; Diphoterine 4 mm)

Improvement of the scarring


The chemical burn
- Mechanism
- Innocuousness


- In vitro data


Prospective study
on ocular chemical burns in Martinique

Merle H, Donnio A, Ayeboua L, Michel F, Thomas T,F, Ketterle J, Leonard C, Josset
P, Gerard M. Alkali ocular burns in Martinique (French West Indies) Evaluation of the
use of an amphoteric solution as the washing product. Burns 2005, 31, 205-211


Clinical study in Martinique
Comparison saline solution / Diphoterine®
Delayed ocular washing

Teams (300 people) : fire-fighters, Emergency Medical Assistance
Service(SAMU), Hospital Emergency Rooms, Ophthalmology
Number of patients : 66 during 4 years (before/after study)
48 eyes (46%) saline solution / 56(54%) Diphoterine®

Protocol : washing with saline solution or Diphoterine® then the
same treatment according to the grade of the burn

Chemicals : bases (48% with Alkali, ammonia 15.3%)

Nature of the splash : attack

victim : male (2 patients out of 3)


Clinical study in Martinique
Comparison saline solution / Diphoterine®
Delayed ocular washing

Length of time (days) Saline Diphoterine® p
reepithelialisation solution
grade 1 11.1±1.4 1.9 ±1 10-7
grade 2 10 ±9.2 5.6 ±4.9 0.02
grade 3 45.2 ±23 20 ±14.1 0.21 NS

Results :

significant difference for grades 1 and 2,
tendency for grade 3,
no grade 4 in the group Diphoterine®

A case report of a severe Grade 4 burn
before the beginning of the clinical study
Woman, 49 years old, assaulted at work place
Grade 4 right eye
Visual acuity < 1/10
Limbic ischemia on 360°
Scleral necrosis
Diphotérine® : 1 hour after the splash
Decrease of stromal edema (AV 0.3)
Application of an adapted treatment
Gérard M, Merle H, Chiambaretta F, Rigal D, Schrage N. An amphoteric rinse used in the emergency treatment
of a serious ocular burn. Burns, 2002, 28, 670-673

Ocular Grade 4
Gérard et al, Burns 2002, 28, 670-673

Healing after 180 days
without grafting


The chemical burn
- Mechanism
- Innocuousness


- In vitro data


A case report of a cutaneous acid splash
July 28 2005
Dr Bérengère BELLIARD, MD

What happened?
Mr B, tube worker, was victim of a chemical burn on his face, neck and
right ear, due to a large amount of 98% sulfuric acid, while
opening a badly purged pipe.

Details of decontamination
Decontamination with water was delayed (around 5 min) and induced
a 3rd degree burn. Decontamination with Diphoterine® started 15 min
after with the arrival of the company nurse at workstation.


Evolution of the lesions

The use of Diphoterine®, beyond an immediate analgesic effect,
allows an important decrease of the seriousness of the burn
Diphotérine Stops the action of the chemical product.

The employee was sent to a hospital emergency room.

4 hours after the accident, the company doctor in accordance
with the emergency room doctor, decided to continue the
washing with Diphoterine® for 24 hours, because of the severity
of the lesions and the foreseeable action of Diphoterine®.

The washing was be followed up 48 hours later at the
employee’s request.


Evolution of the lesions

72 h after the accident, 29 days after the accident,
No edematous grade, wound healing was almost
24 h after the accident, exsudative auditory duct. complete.
some 3rd degree burn areas, No more visible 3rd degree lesions
large edema
.
The employee worked at an adapted workstation in
a clean area during the entire medical treatment.

Effects on burn severity and healing
• Decrease the length of contact with the chemical product
⇒ wash as soon as possible

• Accelerate and optimize the decontamination process
- from the polyvalent and mechanical properties of washing with water
⇒ external decontamination of tissues
- to an active solution with additional chemical and physical properties
⇒ internal decontamination of tissues

• When the burn has already appeared
- apply an adapted treatment to decrease
⇒ inflammation, pain and secondary infection


Evaluation of Decontamination Solutions

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