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Low cost Negative Pressure Wound Therapy device for the purpose of providing affordable health care

Analysis of safety and efficacy parameters of indigenously assembled negative pressure wound therapy (NPWT) system in wound management.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017263
Enrollment
20
Registered
2019-01-25
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: T300- Burn of unspecified body region, unspecified degree Health Condition 2: T149- Unspecified injury

Interventions

Intervention1: indigenously developed NPWT system: two devices on trial will be used on patients. The device A will be applied on wounds with minimal discharge. Larger wounds and those with more disch

Sponsors

Biotechnology industry research assistance council
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted or treated on out-patient basis at Kasturba hospital, Manipal, Government medical college hospital, Thiruvananthapuram, Government medical college hospital, Kottayam, Government medical college hospital, Kozhikode, KS Hegde Medical college hospital, Mangalore for complex wound management as a result of trauma, infection and/or other surgical interventions.

Exclusion criteria

Exclusion criteria: Patients with wounds having excessive necrotic tissue Patients with wounds having exposed major blood vessels Patients with uncontrolled bleeding disorders Patients with wounds resulting from malignant neoplastic tissue. Patients with wounds with high output open fistulae Patients whose wounds have untreated uncontrolled osteomyelitis Patients with severe excoriation of the skin surrounding the wound.

Design outcomes

Primary

MeasureTime frame
Improved wound healing Wound size shrinks Wound is optimized for reconstructive procedures Lesser chances of infection Decreased pain from daily dressings NPWT will be done free of cost. Timepoint: 5 days per patient trial period till 31.10.2019

Secondary

MeasureTime frame
affordable and effective negative pressure wound therapyTimepoint: trial period till 31.10.2019

Countries

India

Contacts

Public ContactJoseph Thomas

Kasturba Medical College, Manipal

joseph.plastic@manipal.edu9995783582

Outcome results

None listed

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