A comparative clinical study to evaluate Skin and Soft Tissue Infections using a non invasive device
Not Applicable
- Conditions
- Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissueHealth Condition 2: L768- Other intraoperative and postprocedural complications of skin and subcutaneous tissue
- Registration Number
- CTRI/2018/10/016147
- Lead Sponsor
- Biotechnology Industry Research Assistance Council BIRAC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 428
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the clinical utility of optical imaging, in identifying infection causing pathogen and its gram type. <br/ ><br>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. <br/ ><br>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 Outcome Measures
Name Time Method To calculate the specificity, sensitivity, Positive predictive value, negative predictive value comparing against microbiology culture report. <br/ ><br>Analyze level of infectionTimepoint: Approximately 7 months