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This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard wound care is effective and safe for treating different types of wounds, including acute wounds (such as burns and surgical incisions), chronic wounds (such as diabetic foot ulcers and pressure injuries), post-grafting wounds, and sutured wounds.
A total of 500 patients receiving standard wound care plus plasma therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients who received standard wound care alone. The main outcomes include wound healing rate at 4 weeks, time to complete wound closure, pain relief, scar formation, and any side effects. Patients will be followed for up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma Device Group | Patients receiving standard wound care plus plasma device therapy. The plasma device is applied to the wound bed at a distance of 5-10 mm for 3-10 minutes per session, once daily or every other day, until complete wound healing or suture removal. |
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| Conventional Treatment Group | Patients receiving standard wound care alone, including wound bed preparation (debridement, infection control, moist healing, dressing changes). This group does not receive plasma device therapy. Patients may be derived from retrospective cases or concurrent non-plasma users, with confounding factors controlled by propensity score matching. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Device | Device | Cold atmospheric plasma device used for non-contact wound treatment. The device generates low-temperature plasma with broad-spectrum antibacterial properties, promoting cell proliferation, modulating inflammation, and improving local microcirculation. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Wound Healing Rate at 4 Weeks | Proportion of wounds (acute wounds, post-grafting wounds, and sutured wounds) achieving complete epithelialization without drainage at 4 weeks post-treatment. | 4 weeks after enrollment |
| Proportion of Wounds Achieving ≥50% Area Reduction at 4 Weeks | For chronic wounds (diabetic foot ulcers, pressure injuries, venous ulcers, radiation ulcers, etc.), the proportion of wounds showing a reduction in wound area of 50% or more compared to baseline at 4 weeks. | 4 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Wound Healing | Number of days from initial treatment to complete wound closure (100% re-epithelialization). | From enrollment to complete epithelialization, assessed up to 6 months |
| Change in Pain Score (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Proportion of participants experiencing local adverse reactions (burns, erythema, blisters, increased exudate, allergy) or systemic adverse reactions (fever, infection spread). Rate of treatment discontinuation due to adverse events will also be recorded. | From enrollment to 6 months follow-up |
Inclusion Criteria:
Exclusion Criteria:
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The study population will be recruited from patients presenting with acute wounds, chronic wounds, post-grafting wounds, or sutured wounds at the wound care centers, burn units, or plastic surgery departments of 10 participating tertiary hospitals across China.
Eligible participants are those who require wound management and meet the inclusion criteria. Patients in the plasma device group will be enrolled prospectively from those receiving standard wound care plus plasma device therapy as part of their routine clinical care. Control group participants will be derived from either: (1) concurrent patients receiving standard wound care alone at the same centers, or (2) retrospectively identified patients from medical records who received standard wound care without plasma therapy. Propensity score matching will be applied to balance baseline characteristics between the two groups.
No special restrictions on gender, race, or socioeconomic status will be applied. The study aims to reflect
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Pain intensity is measured using the Visual Analog Scale (VAS). Scores range from 0 to 10, where higher scores indicate worse pain (0 = no pain, 10 = worst possible pain).
| Baseline, day 3, day 7, day 14, day 21, day 28 |
| Change in Pain Relief/Satisfaction (ASA) | Pain relief and satisfaction are measured using the Analog Scale of Appreciation (ASA). Scores range from 0 to 10, where higher scores indicate better pain relief or greater satisfaction (0 = no appreciation/relief, 10 = complete appreciation/relief). | Baseline, day 3, day 7, day 14, day 21, day 28 |
| Wound Area Reduction Rate | Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%. | Day 7, day 14, day 28 |
| Scar Assessment | Scar quality is evaluated using the Vancouver Scar Scale (VSS) , which assesses vascularity, pigmentation, pliability, and height. The total score ranges from 0 to 13, with higher scores indicating worse scar quality (e.g., greater vascularity, pigmentation, thickness, and reduced pliability). | Month 1, month 3, month 6 |
| Wound Recurrence Rate | 6 months after enrollment | Proportion of participants experiencing recurrence of a wound at the same anatomical site within 6 months after complete healing. |
| Functional Recovery - Local Sensory Function | Local sensory function of the healed wound area is assessed by sensory testing. Unit of Measure: Present vs. absent (or reduced) sensation; or specific monofilament rating (e.g., 2.0-6.0). Higher scores or "present" indicate better sensory function. | 6 months after enrollment |
| Functional Recovery - Sweating Function | Sweating function of the healed wound area is assessed by sweat test (e.g., starch-iodine test). Unit of Measure: Present vs. absent (or reduced) sweating; or area of sweating (cm²). Higher scores or "present" indicate better sweating function. | 6 months after enrollment |