themiseal gel
DESCRIPTION
Unique Topical Haemostatic Hygroscopic agent used for topical treatment of capillary bleeding from surface skin injuries such as – Cuts Scratches Abrasion Wound Minor burnTRANSCRIPT
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
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
• 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
• 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.
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)