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Observation clinical registry study to evaluate safety and efficacy of 0.9% sodium chloride wound irrigation solution in patients having moderate to severe wounds

Post Marketing, Single Arm, Observational Clinical Registry to Evaluate Safety and Efficacy of Sodium Chloride 0.9% Wound Irrigation Solution in all comers real-world population with patients having moderate to severe wounds - Not applicable

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028494
Enrollment
188
Registered
2020-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue

Interventions

Intervention1: NIL: NIL

Sponsors

Amanta Healthcare Limited
Lead Sponsor
Eupraxia Centre For Clinical Excellence LLP
Collaborator

Eligibility

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactRajdeep Patel

Consultant General Surgeon

drpareshshukla@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026