Wound Care
Conditions
Brief summary
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.
Interventions
DEVICEPlasma 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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Presence of any of the following wound types: acute wounds (burns, trauma, surgical incisions, skin avulsions), chronic wounds (diabetic foot ulcers, pressure injuries, venous ulcers, radiation ulcers, burn residual wounds), post-grafting wounds (autograft or allograft, including donor and recipient sites), or sutured wounds (postoperative incisions, flap surgery, tension-reducing sutures). * Age ≥ 12 years (for minors under 18 years, informed consent must be provided by a parent or legal guardian). * Stable vital signs and able to tolerate wound treatment. * Willing to participate and able to provide signed informed consent.
Exclusion criteria
* Active malignant tumor involving the wound area. * Severe systemic infection or sepsis. * Severe immunodeficiency or long-term use of high-dose corticosteroids. * Intolerance to plasma therapy or refusal to participate. * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing Rate at 4 Weeks | 4 weeks after enrollment | Proportion of wounds (acute wounds, post-grafting wounds, and sutured wounds) achieving complete epithelialization without drainage at 4 weeks post-treatment. |
| Proportion of Wounds Achieving ≥50% Area Reduction at 4 Weeks | 4 weeks after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Wound Healing | From enrollment to complete epithelialization, assessed up to 6 months | Number of days from initial treatment to complete wound closure (100% re-epithelialization). |
| Change in Pain Score (VAS) | Baseline, day 3, day 7, day 14, day 21, day 28 | 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). |
| Change in Pain Relief/Satisfaction (ASA) | Baseline, day 3, day 7, day 14, day 21, day 28 | 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). |
| Wound Area Reduction Rate | Day 7, day 14, day 28 | Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%. |
| Scar Assessment | Month 1, month 3, month 6 | 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). |
| Wound Recurrence Rate | Proportion of participants experiencing recurrence of a wound at the same anatomical site within 6 months after complete healing. | 6 months after enrollment |
| Functional Recovery - Local Sensory Function | 6 months after enrollment | 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. |
| Functional Recovery - Sweating Function | 6 months after enrollment | 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. |
Outcome results
None listed