Plasma Therapy for Diverse Wounds

A Prospective, Multicenter, Real-World Observational Study of a Plasma Device for Adjunctive Therapy in Acute Wounds, Chronic Wounds, Post-Grafting Wounds, and Sutured Wounds

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 Overview

• Status: Not yet recruiting
• Conditions: Wound Care
• Intervention / Treatment: Device: Plasma Device

• Study Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Plasma 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: hzc-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No