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 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•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)

•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

发起方

Pragmatic Innovation Inc, Mississauga, ON, Canada