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Clinical Trials/NL-OMON25554
NL-OMON25554
Recruiting
Not Applicable

A Prospective, Randomized, Controlled Trial Comparing Manual Negative Pressure Device (PragmaVAC) versus Gauze Dressing for the Treatment Acute and Chronic Wounds

Pragmatic Innovation Inc, Mississauga, ON, Canada0 sites70 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Pragmatic Innovation Inc, Mississauga, ON, Canada
Enrollment
70
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Pragmatic Innovation Inc, Mississauga, ON, Canada

Eligibility Criteria

Inclusion Criteria

  • We will recruit patients \= 18 years of age with these criteria:
  • 1\-Patients with a full\-thickness wounds that could not be closed immediately.
  • 2\-Infected and non\-infected wounds
  • 3\-Acute and chronic wounds; the latter include pressure ulcers and diabetic foot wounds
  • 4\-Body areas where wound dressing plaster can be sealed (air\-tight)

Exclusion Criteria

  • 1\-Wounds that are considered ready for primary closure by suturing or skin graft.
  • 2\-History of psychiatric disorders that can affect patient’s insight or judgement, namely, schizophrenia and other psychotic disorder, bipolar disorders, dementia, and intellectual disabilities, as assessed by the treating physician.
  • 3\-Body areas where plaster cannot be sealed (e.g. perineum, body folds, presence of external fixators) or an unstable skin around the wound
  • 4\-Standard clinical contraindications to NPWT such as:
  • \- Exposed bone or untreated osteomyelitis
  • \-Superficial bare blood vessels and/or active bleeding
  • \-Deep fistulas in the wound location
  • \-Uncontrolled diabetes
  • 5\-Exposed peritoneum
  • 6\-Systemic sepsis caused by wound infection. These patients could become eligible once their sepsis is resolved and/or necrotic tissue is debrided.

Outcomes

Primary Outcomes

Not specified

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