Themiseal Gel

Unique Topical Haemostatic Hygroscopic agent used for topical treatment of capillary bleeding from surface skin injuries such as –
Cuts
Scratches
Abrasion
Wound
Minor burn

2. SEQUENCE
•Introduction
•How it acts?
•Formulations & its usage
•Indications
•Safety Profile
•Clinical Study
•Discussion

3. INTRODUCTION
•Unique Topical Haemostatic Hygroscopic agent
used for topical treatment of capillary bleeding
from surface skin injuries such as –
–Cuts
–Scratches
–Abrasion
–Wound
–Minor burn

4. Minimizes the
Risk of topical
infection
Restores
tissue
Integrity &
functions
Stops capillary
bleeding
Speeds up
the process
of wound
healing

5. HOW THEMISEAL ACTS?
•Controls capillary
bleeding through
formation of complex
when it comes in contact
with blood

6. HOW THEMISEAL ACTS?
•Creates semi –
transparent physical
barrier and minimize the
risk of entry of foreign
micro-organism and
reduces oozing from
wound

7. HOW THEMISEAL ACTS?
•Maintains moist
environment within
wound, which speeds up
the process of wound
healing

8. HOW TO APPLY THEMISEAL?
•Clean the affected area
with water
•Apply and run thin film
of THEMISEAL gel to
entire affected area

9. APPLICATIONS
•Minor cuts
•Scratches
•Abrasions
•Wounds
•Minor burns

10. SAFETY PROFILE
•THEMISEAL gel is not absorbed into the
systemic circulation due to its high molecular
weight (> 100,000 Dalton)

11. SAFETY PROFILE
•In – Vitro Cell Culture Toxicity Study
•Dermal Sensitization Study
•Primary Skin Irritation Study
Source:
2.Eastern Medikit (Testing lab., New Delhi
3.SGS India Pvt. Ltd., Chennai

12. CLINICAL STUDY
•Objectives
–To assess the efficacy of THEMISEAL gel in various
indications
•Assessment of wound healing
•Type of granulation
•Removal of dressing
•Application of gel

13. CLINICAL STUDY
•Study Centres – 100
•Doctors participated – 144
•Specialty – Mainly Surgeons

14. CLINICAL STUDY
•Clinical study was carried
out on 1204 patients
suffering from various
types of wound
Post operative w ound
37%
Ulcers including Diabetic
ulcers, Pressure ulcers
16%
Superficial burns
7%
Packing of cavities after
incision
15%
Episiotomy w ound dressing
2%
Miscellaneous
12%
Cuts, Abrasions
11%

15. CLINICAL STUDY
•Wound healing was good in 83 % of patients
Excellent
29%
Good
46%
Fair
12%
Nil
13%

16. CLINICAL STUDY
•Granulation type
–Healthy – 972 (89%)
Healthy
89%
Non - healthy
11%

17. CLINICAL STUDY
•Removal of dressing
–Comfortable – 1100 (91%)
Comfortable
91%
Painful
9%

18. CLINICAL STUDY
•Conclusion
–Overall wound healing was good in 87% of the
patients
–Removal of dressing was comfortable in 90% leading
to improved patient compliance
–Healthy granulation was observed in 89% of the
patients

19. CLINICAL STUDY
•Conclusion
–No systemic absorption
–Cool feeling on application – enhances patient co-
operation
–Non – allergenic – no local irritation at the site of
application
–No adverse effect reported

20. ADVANTAGES
•Non – staining
•Non – greasy
•Odourless
•No irritation at the time of application
•Ease of removal of dressing
•Does not enter into systemic circulation

21. NEW MEDICAL DEVICE UNDER
DEVELOPMENT
•Tulle
•Adhesive pads
•Sheer bandages
•Nasal sponges
•Mouth wash
•Spray etc.

22. •ISO : 13485 – 2003
•CE Mark

23. CE MARK
•Often referred as ‘Trade
Passport to Europe’
•Also known as CE Marking
•Mandatory mark for many of
the products circulated on
EFTA & EU single market
(totally 29 countries)

24. CE MARK

25. ISO 13485:2003

26. AUTHORIZED REPRESENTATIVE

27. THANK YOU