safety and effectiveness of Soreze gel in pressure ulcer

Recruiting

Conditions: Pressure ulcer of unspecified site,

Registration Number: CTRI/2021/06/034297

Lead Sponsor: Amaterasu Lifesciences

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 patientâ€™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 oâ€™clock) on ulcerated areas as well as other ulcer prone areas and will be given 2â€“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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 12

Inclusion Criteria

18 YEARS AND ABOVE POPULATION.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
such as erythema, itching,	Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6
Incidence of adverse events	Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6
and pain will be evaluated.	Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6
ï‚·Degrees of overall	Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6
satisfaction with the	Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6
treatment using visual	Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6
analog scale (VAS)	Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6

Secondary Outcome Measures

Name	Time	Method
1.No worsening of grade 1 ulcers	after 21 days of treatment

Trial Locations

Locations (1): Jehangir Clinical Development Centre.Pvt.Ltd
🇮🇳
Pune, MAHARASHTRA, India
Jehangir Clinical Development Centre.Pvt.Ltd
🇮🇳Pune, MAHARASHTRA, India
Dr Kunal Bansal
Principal investigator
9823459296
kun_bansal@yahoo.co.in