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Evaluation of comparative data on eye/skin
     chemical splash decontamination solutions:
        effects on burn severit...
Our job: Chemical Risk
             “Prevent and save”

   Health and care
     – Active washing solutions for chemical sp...
Outline of the presentation
          The chemical burn
       - What is Diphoterine®?
          - Mechanism
          - I...
September 2006, ACS, San Francisco, CA,USA   slide 4   PREVOR Laboratory
Which chemicals
                produce chemical burns?

        Corrosives and irritants:
          – acids, bases, oxidi...
Outline of the presentation
          The chemical burn
       - What is Diphoterine®?
          - Mechanism
          - I...
What is Diphoterine®?
      An aqueous solution containing the fundamental
      properties of water
         washing of a...
Mechanism




               Diphoterine® is a multisite molecule

September 2006, ACS, San Francisco, CA,USA   slide 8   ...
- Medical device: Europe, Canada, Australia, Brazil

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

September 2006, ACS, San Francisco, C...
September 2006, ACS, San Francisco, CA,USA   slide 11   PREVOR Laboratory
Outline of the presentation
        The chemical burn
     - What is Diphoterine®?
        - Mechanism
        - Innocuous...
Clinical results : Case reports
  year Number         Firm / country            Exposure         Body surface
       of ca...
September 2006, ACS, San Francisco, CA,USA   slide 14   PREVOR Laboratory
Clinical results : comparative study
                                       INRS
        (French National Institute of Res...
Clinical results of 42 cases of chemical splashes
                         Martinswerk, Germany, 1991-1993

     washing  ...
Study on 375 cases
                    at ATOFINA, France, 2000

 washing                   water           Diphoterine   ...
Outline of the presentation
        The chemical burn
     - What is Diphoterine®?
        - Mechanism
        - Innocuous...
Diphoterine®: In vitro effects
         by simple dosage of corrosives
                      Dosage of 1ml of normal soda ...
Diphoterine®: In vitro effects
                          Simulation of a complete washing

washing solution
Flow :150ml/mi...
Diphoterine®: In vitro effects

                        Rinsing of 50 ml soda 1N / 25 ml 0.9% NaCl
                       ...
Outline of the presentation
        The chemical burn
     - What is Diphoterine®?
        - Mechanism
        - Innocuous...
In vivo comparative study
                  Saline solution versus Diphoterine®
    18 rabbit eyes
    pHmeter probe in th...
Cornea burnt by ammonia
                                       washing after 3 min of contact


                          ...
Experimental in vivo,
              prospective, randomized, blind
                study of a cutaneous burn
          due...
Skin study in rats
              (concentrated HCl burn)
         Saline solution versus Diphoterine®
   Significant stati...
Outline of the presentation
        The chemical burn
     - What is Diphoterine®?
        - Mechanism
        - Innocuous...
Prospective study
      on ocular chemical burns in Martinique




 Merle H, Donnio A, Ayeboua L, Michel F, Thomas T,F, Ke...
Clinical study in Martinique
               Comparison saline solution / Diphoterine®
                       Delayed ocula...
Clinical study in Martinique
          Comparison saline solution / Diphoterine®
                  Delayed ocular washing
...
A case report of a severe Grade 4 burn
         before the beginning of the clinical study
      Woman, 49 years old, assa...
Ocular Grade 4
                                                     Gérard et al, Burns 2002, 28, 670-673




Healing afte...
Outline of the presentation
        The chemical burn
     - What is Diphoterine®?
        - Mechanism
        - Innocuous...
A case report of a cutaneous acid splash
                                   July 28 2005
                           Dr Bér...
Evolution of the lesions

    The use of Diphoterine®, beyond an immediate analgesic effect,
    allows an important decre...
Evolution of the lesions




                                72 h after the accident,             29 days after the accide...
Effects on burn severity and healing
• Decrease the length of contact with the chemical product
         ⇒ wash as soon as...
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Evaluation of Decontamination Solutions

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Evaluation of Decontamination Solutions

  1. 1. 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
  2. 2. 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 September 2006, ACS, San Francisco, CA,USA slide 2 PREVOR Laboratory
  3. 3. 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 September 2006, ACS, San Francisco, CA,USA slide 3 PREVOR Laboratory
  4. 4. September 2006, ACS, San Francisco, CA,USA slide 4 PREVOR Laboratory
  5. 5. 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 ! September 2006, ACS, San Francisco, CA,USA slide 5 PREVOR Laboratory
  6. 6. 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 September 2006, ACS, San Francisco, CA,USA slide 6 PREVOR Laboratory
  7. 7. 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 September 2006, ACS, San Francisco, CA,USA slide 7 PREVOR Laboratory
  8. 8. Mechanism Diphoterine® is a multisite molecule September 2006, ACS, San Francisco, CA,USA slide 8 PREVOR Laboratory
  9. 9. - Medical device: Europe, Canada, Australia, Brazil Mathieu L. Accepted for publication in J Toxicol -- Cutaneous and Ocular Toxicology September 2006, ACS, San Francisco, CA,USA slide 9 PREVOR Laboratory
  10. 10. Mathieu L. Accepted for publication in J Toxicol -- Cutaneous and Ocular Toxicology September 2006, ACS, San Francisco, CA,USA slide 10 PREVOR Laboratory
  11. 11. September 2006, ACS, San Francisco, CA,USA slide 11 PREVOR Laboratory
  12. 12. 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 September 2006, ACS, San Francisco, CA,USA slide 12 PREVOR Laboratory
  13. 13. 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 September 2006, ACS, San Francisco, CA,USA slide 13 PREVOR Laboratory
  14. 14. September 2006, ACS, San Francisco, CA,USA slide 14 PREVOR Laboratory
  15. 15. 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 September 2006, ACS, San Francisco, CA,USA slide 15 PREVOR Laboratory
  16. 16. 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 September 2006, ACS, San Francisco, CA,USA slide 16 PREVOR Laboratory
  17. 17. 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 September 2006, ACS, San Francisco, CA,USA slide 17 PREVOR Laboratory
  18. 18. 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 September 2006, ACS, San Francisco, CA,USA slide 18 PREVOR Laboratory
  19. 19. 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 September 2006, ACS, San Francisco, CA,USA slide 19 PREVOR Laboratory
  20. 20. Diphoterine®: In vitro effects 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 September 2006, ACS, San Francisco, CA,USA slide 20 PREVOR Laboratory
  21. 21. Diphoterine®: In vitro effects 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 September 2006, ACS, San Francisco, CA,USA slide 21 PREVOR Laboratory
  22. 22. 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 September 2006, ACS, San Francisco, CA,USA slide 22 PREVOR Laboratory
  23. 23. 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
  24. 24. 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 September 2006, ACS, San Francisco, CA,USA slide 24 PREVOR Laboratory
  25. 25. 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 September 2006, ACS, San Francisco, CA,USA slide 25 PREVOR Laboratory
  26. 26. 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 September 2006, ACS, San Francisco, CA,USA slide 26 PREVOR Laboratory
  27. 27. 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 September 2006, ACS, San Francisco, CA,USA slide 27 PREVOR Laboratory
  28. 28. 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 September 2006, ACS, San Francisco, CA,USA slide 28 PREVOR Laboratory
  29. 29. 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) September 2006, ACS, San Francisco, CA,USA slide 29 PREVOR Laboratory
  30. 30. 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® September 2006, ACS, San Francisco, CA,USA slide 30 PREVOR Laboratory
  31. 31. 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
  32. 32. Ocular Grade 4 Gérard et al, Burns 2002, 28, 670-673 Healing after 180 days without grafting September 2006, ACS, San Francisco, CA,USA slide 32 PREVOR Laboratory
  33. 33. 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 September 2006, ACS, San Francisco, CA,USA slide 33 PREVOR Laboratory
  34. 34. 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. September 2006, ACS, San Francisco, CA,USA slide 34 PREVOR Laboratory
  35. 35. 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. September 2006, ACS, San Francisco, CA,USA slide 35 PREVOR Laboratory
  36. 36. 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. September 2006, ACS, San Francisco, CA,USA slide 36 PREVOR Laboratory
  37. 37. 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 September 2006, ACS, San Francisco, CA,USA slide 37 PREVOR Laboratory

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