Chronic wounds
Conditions
Interventions
treatment group:topical continuous diffusion of oxygen combined with moist wound therapy
control group:Standard moist wound therapy
Sponsors
Wound Care Center of Outpatient Department, Eastern Theater General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged =18 years at the time of consent; (2) Wound that meets the definition chronic wound,including 3-4 pressury injury, Wagner 2-4 diabetic foot ulcer (Blood glucose control in the normal range, fasting blood glucose 3.9-6.1 mmol/L, 2 hours postprandial blood glucose = 7.8mmol/L), venous leg ulcer, surgical site infection,traumatic wound; (3) An index wound area measuring between 1.5–10cm2 after debridement at time of randomisation; (4) The quantity of exudate<15mL/d; (5) Subjects can follow the intervention and follow-up plan.
Exclusion criteria
Exclusion criteria: (1) Malignant wound; (2) Active bleeding wound; (3) Necrotic wounds covered with eschar or slough,but debridement is contraindicated or cannot be performed; (4) The wound edges are difficult to seal to create an occlusive environment; (5) Chronic wound secondary to infection requiring antibiotic treatment or being treated with antibiotics at the time of screening; (6) Systemic comorbidities that affect wound healing include autoimmune disease, malnutrition,advanced tumor,multiple organ failure, and unstable blood glucoseat the time of screening; (7) Receiving or has received steroids,immunosuppression, radiation or chemotherapy within three months of randomisation; (8) Subjects who have untreated osteomyelitis; (9) Enrolled or who have participated,within three months of randomisation,in another investigational device, drug or biological trial that may interfere with study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound closed rate during the intervention period; | — |
Secondary
| Measure | Time frame |
|---|---|
| the percentage decrease in wound surface area,wound depth;bacterial species change;PUSH score;wound temperature;wound PH;MMP-9 expression;CD34 expression;Ki-67 expression; | — |
Countries
China
Contacts
Public ContactJiang Qixia
Outcome results
None listed