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.
Investigators
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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