Observation clinical registry study to evaluate safety and efficacy of 0.9% sodium chloride wound irrigation solution in patients having moderate to severe wounds
Phase 4
Completed
- Conditions
- Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
- Registration Number
- CTRI/2020/10/028494
- Lead Sponsor
- Amanta Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 188
Inclusion Criteria
Inclusion Criteria:
Patient will be included if ALL of the following criteria are met:
1. Patients above >=18 years of age.
2. Patients who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
3. Patients who have been administered study product by Investigator as part of standard of care (SOC) practice and consent has been provided by patient post administration of study product on the same day.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the safety and efficacy of 0.9% sodium chloride wound irrigation solution in real world patients with patients with moderate to severe wound surface area, wound volume, wound bed surface.Timepoint: Day 1, Day 05, and Day 10
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI