| CTRI Number |
CTRI/2021/06/034297 [Registered on: 18/06/2021] Trial Registered Prospectively |
| Last Modified On: |
25/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Protectant Gel ] |
| Study Design |
Other |
|
Public Title of Study
|
safety and effectiveness of Soreze gel in pressure ulcer |
|
Scientific Title of Study
|
A clinical study to evaluate the safety, tolerability and effectiveness of
Soreze gel in existing Grade 1 pressure ulcers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKunal Bansal |
| Designation |
Consultant orthopedic surgeon |
| Affiliation |
Jehangir Clinical Development Centre.Pvt.Ltd. |
| Address |
Jehangir Hospital Premises 32 Sassoon Road
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
kun_bansal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Maharukh T Rustomjee |
| Designation |
Managing partner |
| Affiliation |
AMATERASU LIFESCIENCES LLP |
| Address |
2/51, Air Condition Market, Pandit Madan Mohan
Malviya Marg, Tardeo
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820228088 |
| Fax |
- |
| Email |
maharukh@amaterasu.in |
|
Details of Contact Person
Public Query
|
| Name |
Maharukh T Rustomjee |
| Designation |
Managing partner |
| Affiliation |
AMATERASU LIFESCIENCES LLP |
| Address |
2/51, Air Condition Market, Pandit Madan Mohan
Malviya Marg, Tardeo
Osmanabad
MAHARASHTRA
400034
India |
| Phone |
9820228088 |
| Fax |
- |
| Email |
maharukh@amaterasu.in |
|
|
Source of Monetary or Material Support
|
| Jehangir Clinical Development Centre.Pvt.Ltd. |
|
|
Primary Sponsor
|
| Name |
Amaterasu Lifesciences |
| Address |
2/51, Air Condition Market, Pandit Madan Mohan
Malviya Marg, Tardeo, Mumbai 400034 |
| Type of Sponsor |
Other [Innovation driven development of new topical/dermatological and injectable drug delivery system. ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kunal Bansal |
Jehangir Clinical Development Centre.Pvt.Ltd |
OPD NO 12, Ground Floor Jehangir Hospital Premises 32 Sasoon Road
Pune
MAHARASHTRA |
9823459296
kun_bansal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Jehangir Clinical Development Centre.Pvt.Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L899||Pressure ulcer of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Soreze Gel |
Soreze Gel Soreze is a skin protectant gel
and a soothing composition
of silicone elastomers,
polysiloxane and starch that
uses patented EPB
(Elastomer Potentiated
Barrier) technology to
provide anti-friction barrier
protection to the skin.The product is to be applied twice daily for 21 days
(at 9 and 21 o’clock) on ulcerated areas as well as other ulcer prone areas and will be given
2–3 min to absorb. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
18 YEARS AND ABOVE POPULATION |
|
| ExclusionCriteria |
| Details |
The length of stay counting from first day of admission
in one or (if the patient is transferred to another ward)
more participating wards.
Were terminally ill or receiving chemotherapy
Presence of diabetes both Type I and II
Were allergic to the components of a study product
Had peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of adverse events
such as erythema, itching,
and pain will be evaluated.
ï‚·Degrees of overall
satisfaction with the
treatment using visual
analog scale (VAS)
|
Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.No worsening of grade 1 ulcers
after 21 days of treatment
assessed using Braden scale.
2.No formation of grade 1 ulcers
in other bed sore prone areas
using Braden scale.
3.Use of local management
pressure system
4.Time a patient spent during
the day in a
recumbent/semi-recumbent
position and seated in a
chair
5.Frequency of repositioning
|
At Visit1, Visit 2, Visit 3, Visit 4,Visit 5 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All the hospitalized patients falling under the inclusion criteria will be examined and those with grade 1 pressure ulcers (PU) and sign the informed consent will be recruited in the study. This will be a single arm open label study. The PUs prevention methods as per hospital protocol (e.g. daily evaluation of patient’s skin at a fixed timing, especially examination of pressure areas such as the sacrum, trochanter, heel, occipital area, shoulder, and changing. positions at least every 2 hours, using a small pillow between legs or heels to remove and reduce the pressure, urinary and fecal incontinence control, and using absorbent pads and cleaning the skin in case of contamination) will be done on a daily basis by nurses in the form of usual nursing care for all the patients and recorded. Soreze gel will be applied on the ulcerated or ulcer prone area. Before the removal of first dose, tube should be weighed and its weight to be recorded. The study doctor will observe the site for 2 hours for any local reactions like redness, a rash, or hives. The product is to be applied twice daily for 21 days (at 9 and 21 o’clock) on ulcerated areas as well as other ulcer prone areas and will be given 2–3 min to absorb. IP should be applied in a quantity just sufficient to form a thin film on affected area or PU prone area and little wider to cover the adjacent areas. While application of IP, apply the first layer of the product, allow to dry for a few seconds and then apply another thin layer on the area. This helps cover all the area very well. Please note only thin film is sufficient, ensure no affected areas should be left without film. In case of discharge from hospital before day 21, further follow up with the patient or care provider will be done telephonically. Patient or his care provider will be trained to record the necessary observations and patient diary will be maintained for IP compliance, PU prevention methods and recording relevant observations. If the day 21 visit gets delayed, patient must be asked to continue the application of IP till the day of last visit. IP application will be recorded and tube will be reweighed to record the weight after removal of last dose. Average weight of the product used can be calculated from the difference of final and initial tube weights. Ulcerated areas will be examined on days 0, 1, 3, 7, 14-and 21- days for safety parameters and reduction in ulceration |