Wound CareNCT07553689
Plasma Therapy for Diverse Wounds
An observational study of Wound Care, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Care
- What is being tested?
- Plasma Device
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Wound Care
- Being tested
- Plasma Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Plasma Device | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks after enrollment
Secondary outcomes (8)
Time to Complete Wound Healing
Number of days from initial treatment to complete wound closure (100% re-epithelialization).
Measured: 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).
Measured: 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).
Measured: 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%.
Measured: 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).
Measured: Month 1, month 3, month 6
Wound Recurrence Rate
6 months after enrollment
Measured: 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.
Measured: 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.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Zhicheng, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553689
- Sponsor's protocol ID
- hzc-01
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07553689
- Acronym / sponsor ID
- hzc-01
- Conditions
- Wound Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma Device Group | – | Device: Plasma DevicePatients 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma 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. | Device | Plasma Device Group |
Primary outcome
Complete Wound Healing Rate at 4 Weeks
Time frame: 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
Time frame: 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.
8 secondary outcomes
Time to Complete Wound Healing
Time frame: From enrollment to complete epithelialization, assessed up to 6 months
Change in Pain Score (VAS)
Time frame: Baseline, day 3, day 7, day 14, day 21, day 28
Change in Pain Relief/Satisfaction (ASA)
Time frame: Baseline, day 3, day 7, day 14, day 21, day 28
Wound Area Reduction Rate
Time frame: Day 7, day 14, day 28
Scar Assessment
Time frame: Month 1, month 3, month 6
Wound Recurrence Rate
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
Time frame: 6 months after enrollment
Functional Recovery - Sweating Function
Time frame: 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Wound Care
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Recruiting
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
Neuro-Degenerative Diseases, Care Givers
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Care, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Healing Rate at 4 Weeks (time frame: 4 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.