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Benefit of using composite nanoparticle formulation in patients with infected wounds compared to standard wound management

Evaluation of the benefit of using a composite formulation containing silver nanoparticle in patients with infected wounds compared to standard wound management: A prospective randomised open label parallel clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041120
Enrollment
100
Registered
2022-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissue Health Condition 2: L089- Local infection of the skin and subcutaneous tissue, unspecified Health Condition 3: L768- Other intraoperative and postprocedural complications of skin and subcutaneous tissue

Interventions

Intervention1: Kadermin (silver nanoparticle) cream: Kadermin cream arm: The Kadermin (silver nanoparticle) cream shall be applied topically on the wounds at 1gm/cm2 dosage daily once for minimum of 5

Sponsors

Kalinga Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged more than 18 years of age 2. Patients admitted with infected wound with swab/pus/tissue culture positive for a bacteria 3. Wound of any type and any area (body part) including either post-surgery, trauma, burn or chronic underlying illness like diabetes 4. Willingness to comply with study instructions for its duration as indicated by written informed consent from the patient

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women, 2. The wound with underlying cancer 3. Patients with underlying immunocompromised status (infected with HIV, any immunodeficiency) 4. Patient is sick enough requiring life support or vasopressors. 5. Participation in any clinical study, which may interfere with the current study

Design outcomes

Primary

MeasureTime frame
Microbiological clearance of the wound (bacteria isolated from the would swab)Timepoint: Day 5 and Day 10

Secondary

MeasureTime frame
Wounds healing (presence necrotic tissue (slough/eschar), presence of pus/exudate, smell, wound bed colour, presence of granulation tissue, colour of epithelial tissue, and features of healing) and features of contraction Timepoint: DAY 10

Countries

India

Contacts

Public ContactDr Basanti Kumari Pathi

Kalinga Institute of Medical Sciences

pathibasanti@gmail.com07735285610

Outcome results

None listed

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