SEQUENCE

• Introduction

• How it acts?

• Formulations & its usage

• Indications

• Safety Profile

• Clinical Study

• Discussion

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

Minimizes the Risk of topical

infection

Restores tissue

Integrity & functions

Stops capillarybleeding

Speeds up the process

of wound healing

HOW THEMISEAL ACTS?

• Controls capillary

bleeding through

formation of complex

when it comes in contact

with blood

HOW THEMISEAL ACTS?

• Creates semi –

transparent physical

barrier and minimize the

risk of entry of foreign

micro-organism and

reduces oozing from

wound

HOW THEMISEAL ACTS?

• Maintains moist

environment within

wound, which speeds up

the process of wound

healing

HOW TO APPLY THEMISEAL?

• Clean the affected area

with water

• Apply and run thin film

of THEMISEAL gel to

entire affected area

APPLICATIONS

• Minor cuts

• Scratches

• Abrasions

• Wounds

• Minor burns

SAFETY PROFILE

• THEMISEAL gel is not absorbed into the

systemic circulation due to its high molecular

weight (> 100,000 Dalton)

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

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

CLINICAL STUDY

• Study Centres – 100

• Doctors participated – 144

• Specialty – Mainly Surgeons

CLINICAL STUDY

• Clinical study was carried

out on 1204 patients

suffering from various

types of wound

Post operative w ound37%

Ulcers including Diabetic ulcers, Pressure ulcers

16%

Superficial burns7%

Packing of cavities after incision

15%

Episiotomy w ound dressing2%

Miscellaneous12%

Cuts, Abrasions11%

CLINICAL STUDY• Wound healing was good in 83 % of patients

Excellent 29%

Good 46%

Fair12%

Nil13%

CLINICAL STUDY• Granulation type

– Healthy – 972 (89%)

Healthy89%

Non - healthy11%

CLINICAL STUDY• Removal of dressing

– Comfortable – 1100 (91%)

Comfortable91%

Painful9%

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

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

ADVANTAGES

• Non – staining

• Non – greasy

• Odourless

• No irritation at the time of application

• Ease of removal of dressing

• Does not enter into systemic circulation

NEW MEDICAL DEVICE UNDER DEVELOPMENT

• Tulle

• Adhesive pads

• Sheer bandages

• Nasal sponges

• Mouth wash

• Spray etc.

• ISO : 13485 – 2003

• CE Mark

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)

CE MARK

ISO 13485:2003

AUTHORIZED REPRESENTATIVE

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