Plasma Therapy for Diverse Wounds

N/ANot Yet RecruitingNCT07553689

First Affiliated Hospital, Sun Yat-Sen University1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Wound Care

Interventions

Plasma DeviceDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks after enrollment

Secondary Outcomes

Time to Complete Wound Healing

Number of days from initial treatment to complete wound closure (100% re-epithelialization).

Time frame: From enrollment to complete epithelialization, assessed up to 6 months

Change in Pain Score (VAS)

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).

Time frame: 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).

Time frame: 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%.

Time frame: 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).

Time frame: Month 1, month 3, month 6

Wound Recurrence Rate

6 months after enrollment

Time frame: 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.

Time frame: 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.

Time frame: 6 months after enrollment