Validation of Manual Negative Pressure Wound Therapy for Open Wounds

Recruiting

Conditions: Acute and chronic open wounds

Registration Number: NL-OMON25554

Lead Sponsor: Pragmatic Innovation Inc, Mississauga, ON, Canada

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

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.
7-Grossly necrotic wounds
8-Malignancy in the wound

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of dressings and duration in days required for the wound to become ready for closure, defined by nourished wound bed with good granulation tissue.<br><br>N.B. The final wound closure (by suturing, split-thickness skin graft, or secondary intention) is outside the scope of the trial.

Secondary Outcome Measures

Name	Time	Method
-Wound shrinkage measured from day 1 of treatment to primary outcome<br><br>-Wound infection observed by clinical signs of infection and purulent discharge<br>