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Clinical Trials/ISRCTN23090333
ISRCTN23090333
Completed
N/A

Pilot study designed to assess functionality of a low-cost negative pressure wound therapy system in patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps, grafts and surgical incisions

Healyx Labs0 sites15 target enrollmentMay 30, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Healyx Labs
Enrollment
15
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 30, 2018
End Date
May 26, 2018
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Healyx Labs

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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