Health Condition 1: L89- Pressure ulcer
Conditions
Interventions
Intervention1: AgFix® non adhesive foam silver dressing.
: AgFix® is a sterile dressing which has a non-adherent polyethylene net and nylon fabric coated with metallic silver. This dressing upon inte
Sponsors
Dynamic Techno Medicals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female subject over 18?and upto 70 years of age 2 Subject with pressure ulcers belonging to stage II (PrU-II) according to the US National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) guideline 3 Subject with at least one pressure ulcer. In case the subject has more than one PrU-II, only the largest diameter ulcer will be assessed. 4 Pressure ulcer size of 1-10 cm2 at screening 5 Subject who have given written informed consent
Exclusion criteria
Exclusion criteria: 1 Subject with pressure ulcers other than stage II according to the US National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) guideline 2 Subject with terminal situation (life expectancy less than 6?months) or requiring ICU admission 3 Subject with history of allergy to materials in the study dressings. 4 Subject having ulcers from other aetiologies (tumour, infection, amputation, dehisced surgical, venous, ischaemic, traumatic or diabeticfoot ulcer) 5 Subject with pressure ulcer in previously irradiated areas 6 Wounds treated with negative pressure therapy 7 Subject who is pregnant, parturient, or breastfeeding 8 Subject with immunodeficiency, random blood sugar >180 mg/dL, osteomyelitis, peripheral vascular illness or other systemic inflammatory disease 9 Subject with active neoplastic lesion treated with radiation or chemotherapy 10 Subject requiring MRI (Magnetic Resonance Imaging) examination during the course of the study 11 Subject who received an experimental drug or used an experimental study dressing within 30 days prior to the planned start of procedure 12 Subject already participating in another clinical study 13 Subject unlikely to comply with study procedure or complete the scheduled follow up visit, in the opinion of PI 14 Employee of the PI or study center with direct involvement in the proposed study or other studies under the direction of that PI or study center 15 Subject with mental disorder, learning disability, or language barrier 16 Any confirmed or suspected SARS-CoV-2 virus/variant or COVID-19 disease 17 Other indication-based exclusion, in opinion of PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of ulcers healed within 8 weeks of study periodTimepoint: Week1 Week2 Week3 Week4 Week5 Week6 Week7 Week8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall healing score by Pressure Ulcer Scale for healing Change in wound surface area Time to complete healing Number and frequency of dressing changes Time to first and subsequent change of dressings Length of hospital stay Wound area photography Percentage of patients with AE Subject-reported pain intensity of pressure using visual analogue scale (VAS) Subjects’ perceptions with regard to dressing application HCP reported satisfaction with dressing Other adverse events and material problems QOL assessmentTimepoint: Day 0 Week1 Week2 Week3 Week4 Week5 Week6 Week7 Week8 | — |
Countries
India
Contacts
Public ContactDr Radhesh Kumar
WorkSure MedPharma Consultancy India Pvt. Ltd
Outcome results
None listed