Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
None listed
Sponsors
Datt Mediproducts Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female of age group between 18 to 70 years (Adult, Older Adult). 2. Subjects must be able to read and understand informed consent, and sign the informed consent to provide data for the study. 3. Subjects who allow their data to be collected for the study at predefined follow-up periods. 4. Female subject that is willing to take contraceptive pills for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. 5. Subjects suffering from infected wound with size more than 25/30 square centimeter. 6. Subjects having a traumatic infected wound with duration less than 1 month.
Exclusion criteria
Exclusion criteria: 1. Subject unwilling or unable to comply with the follow up visits necessary for data collection. 2. Subject found positive for HIV, HBsAg and HCV. 3. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study. 4. Pregnant females. 5. Subject with Immunosuppression, corticosteroids or chemotherapy. 6. Subject with decision making impairment. 7. Subject with a severe comorbid disorder, not expected to survive more than 12 months. 8. Diabetic foot infections. 9. Allergies to any material contained investigational devices. 10. Subjects with burn wounds, DFU, malignant ulcers, tubercular ulcers, leprotic ulcers, gangrenous ulcers, ischemic ulcers, bed sores. 11. Any other condition which, according to the judgment of the investigator, could interfere in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of dressings and time required (in days) to achieve complete wound closure. Healing is based on Favorable healing outcome (FHO) at a time frame of 24 days. An FHO is considered to have occurred in a given patient if all the following composite endpoints are met: I.Total wound area (sum of areas of all present wounds on both limbs) has decreased, compared to baseline (Screening), by 100% at or before the scheduled last visit. II.Comparative evaluation of wounds through Bates-Jensen Wound Assessment Tool and assessment of wound photographs at each visit. III.Evaluate bacterial load before (Day 0), Day 8, Day 16 and on the last day (Day 24). Timepoint: (Day 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Comparative evaluation of wound infection during the study period assessed through TLC and DLC evaluation. ii. Comparative evaluation of each of the observation used to define FHO at time frame of 24 days. iii. Comparative evaluation of the number of complete wound closures. iv. Number of local cares requiring instrumental debridement (surgical or sharp debridement) in 24 days duration. v. Number of subjects reporting relive from pain Comparative evaluation of Subject pain level based on a 0-10 Numeric Pain Chart on each dressing day and its final removal (0 - no pain, 10 - worst pain imaginable). They will be instructed to share the medication name, dosage, and number of pills if they are given analgesics for pain relief. vi. Assessment of infection level. vii. Comparative evaluation of Subject for their infection level based on TLC and DLC values. Timepoint: 24 days | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
S.N Medical College, Agra
Outcome results
None listed