Plasma Therapy for Diverse Wounds
ConditionWound Care
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Plasma Device
DeviceCold 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Plasma Device Group1 intervention
Group B: Conventional Treatment Group0 interventions
Trial outcomes
Primary outcomes
1
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 enrollment2
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 enrollmentSecondary outcomes
1
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 months2
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 283
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 284
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 28Other outcomes
1
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.
Time frame
From enrollment to 6 months follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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