Acute and chronic open wounds
Conditions
Interventions
Wounds in the intervention group will be covered with standard NPWT dressing, consisting of specialized foam covering the wound pad, and then sealed with an air-tight drapes. A tube extends from the f
Sponsors
Pragmatic Innovation Inc, Mississauga, ON, Canada
Eligibility
Inclusion 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
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. 7- Grossly necrotic wounds 8- Malignancy in the wound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of dressings and duration in days required for the wound to become ready for closure, defined by nourished wound bed with good granulation tissue. N.B. The final wound closure (by suturing, split-thickness skin graft, or secondary intention) is outside the scope of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Wound shrinkage measured from day 1 of treatment to primary outcome - Wound infection observed by clinical signs of infection and purulent discharge | — |
Contacts
Public ContactHisham Alshaer
Pragmatic Innovation Inc
Outcome results
None listed