Health Condition 1: L899- Pressure ulcer of unspecified site
Conditions
Interventions
Intervention1: High Purity Type-I Collagen-based Skin Substitute: The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute followed by a padded 3-layer dress
Sponsors
Adichunchangiri University
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must be at least 18 years of age or older. There should be presence of a Stage II or Stage III pressure ulcer, as defined by the National Pressure Ulcer Advisory Panel with ulcer size between 5 cm and 25 cm
Exclusion criteria
Exclusion criteria: A subject known to have a life expectancy of less than 6 months or presence of infection in the ulcer requiring systemic antibiotics or with known allergy to components of HPTC or dHCAM are excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage wound area reduction Description: Wound area will be measured at time of enrollment and after device application through week. It is measured manually every week post application till 6 weeks with digital photographyTimepoint: Percentage wound area reduction Description: Percentage wound area reduction will be assessed at time of enrollment, and after device application at 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks. Wound area is measured manually with digital photography | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve complete wound closure Description: The time to achieve complete wound closure of the target ulcer by the end of 6 weeksTimepoint: Time Frame: 4 weeks;Infiltration of vascularity in the ulcer bed Description: Infiltration of vascularity in the ulcer bed on day 5 of application. Vascularity assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Subsequently histopathology of biopsy will be done to look for: (a) increase in number of blood vessels - as percentage change (b) increase in size of blood vessel - as percentage changeTimepoint: Time Frame: 6 days;Mean number of repeated application Description: Mean number of repeated applications of the Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closureTimepoint: Time Frame: 4 weeks;Incidence of adverse events Description: Incidence of adverse events related to the intervention (e.g., infection, allergic reactions)Timepoint: Time Frame: 4 weeks;Patient treatment satisfaction Description: Patient treatment satisfaction will be assessed by using Likert Scale measured with score range from 1 to 5, wherein 1=Extremally Unsatisfied to 5=Extremally SatisfiedTimepoint: Time Frame: 4 weeks including 1-week follow-up | — |
Countries
India
Contacts
Public ContactDr Naveen Narayan
Adichunchanagiri Institute of Medical Sciences
Outcome results
None listed