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

Phase 2

• Conditions: Health Condition 1: T14- Injury of unspecified body region

• Registration Number: CTRI/2021/02/031120
• Lead Sponsor: BIRAC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>2. Microbiological evaluation of bacterial <br/ ><br>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 <br/ ><br>Timepoint: the outcomes will be evaluated after 5 days or 120 hours after initial application at the time of opening of the wound dressing <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
complete healing of woundTimepoint: At the time of opening of dressing after 5 days or 120 hours after initial application of the dressing