Pilot study designed to assess functionality of a low-cost negative pressure wound therapy system

Completed

• Conditions: Not Applicable; Chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps, grafts and surgical incisions

• Registration Number: ISRCTN23090333
• Lead Sponsor: Healyx Labs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-26
• Study Start: 2018-05-30
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Patient is 18 years of age or older
2. Patient presents with an open wound
3. Patient is able to understand study requirements, is willing to undergo subject procedures, provide any required subject feedback, and provide informed consent to participate in the study

Exclusion Criteria

1. Patient who is pregnant or nursing
2. Patient with a non-survivable wound, life expectancy of 7 days or less
3. Patient’s wound is of malignant or vasculitis origin, or shows presence of necrotic tissue
4. Patient’s wound has active bleeding, exposed blood vessels or organs
5. Patient with wound-related comorbidities, including diabetic ketoacidosis, Hyperglycaemic Hyperosmolar Nonketotic Coma, vascular disease, or arthritis
6. Patient currently using medications that cause immune suppression
7. Patient with wound considered too difficult to seal based on location
8. Patient unable to understand study or provide informed consent to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified