Analysis of safety and efficacy parameters of indigenously asembled portable mini negative pressure wound therapy device in wound management .

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031120

Enrollment

100

Registered

2021-02-09

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: T14- Injury of unspecified body region

Interventions

Intervention1: negative pressure wound therapy: A controlled vacuum is applied using an airtight sterile dressing over wounds Intervention2: Negative pressure wound therapy using a miniaturized system

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, Kozhikode, KS Hegde Medical college hospital, Mangalore between 1.3.2020 and 28.2.2021 for complex wound management as a result of trauma, infection and/or other surgical interventions.

Exclusion criteria

Exclusion criteria: Patients with wounds greater than 200 sq. cms. 2. Patients with wounds having excessive necrotic tissue 3. Patients with wounds having exposed major blood vessels 4. Patients with uncontrolled bleeding disorders 5. Patients with wounds resulting from malignant neoplastic tissue. 6. Patients with wounds with high output open fistulae 7. Patients whose wounds have untreated uncontrolled osteomyelitis 8. Patients with severe excoriation of the skin surrounding the wound.

Design outcomes

Primary

Measure	Time frame
1. Clinical a) WOUND DIMENSIONS b) EPITHELIZATION c) GRANULATION d) Clinical deterioration of wound: Increased necrotic tissue ii. Erythema iii. Deterioration in quality of granulation tissue iv. Epithelisation v. Adverse wound reactions to the dressing 2. Microbiological evaluation of bacterial 3. Technical parameters: a) Number of hours of working of the NPWT unit. B) Number of episodes of device malfunction i. Number of events per machine in 6 months ii. Reason for malfunction Timepoint: the outcomes will be evaluated after 5 days or 120 hours after initial application at the time of opening of the wound dressing	—

Measure

Time frame

1. Clinical a) WOUND DIMENSIONS b) EPITHELIZATION c) GRANULATION d) Clinical deterioration of wound: Increased necrotic tissue ii. Erythema iii. Deterioration in quality of granulation tissue iv. Epithelisation v. Adverse wound reactions to the dressing 2. Microbiological evaluation of bacterial 3. Technical parameters: a) Number of hours of working of the NPWT unit. B) Number of episodes of device malfunction i. Number of events per machine in 6 months ii. Reason for malfunction Timepoint: the outcomes will be evaluated after 5 days or 120 hours after initial application at the time of opening of the wound dressing

—

Secondary

Measure	Time frame
complete healing of woundTimepoint: At the time of opening of dressing after 5 days or 120 hours after initial application of the dressing	—

Countries

India

Contacts

Public ContactDr Joseph Thomas

Kasturba medical college, Manipal

dr.joethomas@gmail.com9995783582

Outcome results

None listed

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