Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissue Health Condition 2: L768- Other intraoperative and postprocedural complications of skin and subcutaneous tissue
Conditions
Interventions
Intervention1: SKINSCOPE DEVICE: A rapid handheld, non-invasive, non contact device that can detect and classify clinically relevant pathogens causing skin and soft tissue infections in real-time. The
Sponsors
Biotechnology Industry Research Assistance Council BIRAC
Eligibility
Inclusion criteria
Inclusion criteria: Patients with chronic and new foot ulcers with non intact Skin( Scars, surgical site, skin tear, Stasis ulcer both arterial and venous).
Exclusion criteria
Exclusion criteria: Patients with skin diseases, auto immune diseases. Developing ulcer with intact skin. Treatment with an investigational drug within 1 month before study enrolment Any contra-indication to routine wound care and/or monitoring Inability to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the clinical utility of optical imaging, in identifying infection causing pathogen and its gram type. 2. To calculate the specificity of the screening device in effectively detecting the pathogen colonization patterns in skin ulcers and aid physicians with effective treatment protocols. 3. Analyze level of infectionTimepoint: Approximately imaging 1 week per patient during their period of hospital stay and 1 day in case of OPD | — |
Secondary
| Measure | Time frame |
|---|---|
| To calculate the specificity, sensitivity, Positive predictive value, negative predictive value comparing against microbiology culture report. Analyze level of infectionTimepoint: Approximately 7 months | — |
Countries
India
Contacts
Public ContactGeethanjali Radhakrishnan
Adiuvo Diagnostics Pvt Ltd
Outcome results
None listed