safety and effectiveness of Soreze gel in pressure ulcer
Not Applicable
- Conditions
- Health Condition 1: L899- Pressure ulcer of unspecified site
- Registration Number
- CTRI/2021/06/034297
- Lead Sponsor
- Amaterasu Lifesciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
18 YEARS AND ABOVE POPULATIO
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 Incidence of adverse events <br/ ><br>such as erythema, itching, <br/ ><br>and pain will be evaluated. <br/ ><br>ï?·Degrees of overall <br/ ><br>satisfaction with the <br/ ><br>treatment using visual <br/ ><br>analog scale (VAS) <br/ ><br>Timepoint: Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.No worsening of grade 1 ulcers <br/ ><br>after 21 days of treatment <br/ ><br>assessed using Braden scale. <br/ ><br>2.No formation of grade 1 ulcers <br/ ><br>in other bed sore prone areas <br/ ><br>using Braden scale. <br/ ><br>3.Use of local management <br/ ><br>pressure system <br/ ><br>4.Time a patient spent during <br/ ><br>the day in a <br/ ><br>recumbent/semi-recumbent <br/ ><br>position and seated in a <br/ ><br>chair <br/ ><br>5.Frequency of repositioning <br/ ><br>Timepoint: At Visit1, Visit 2, Visit 3, Visit 4,Visit 5