Plasma Therapy for Diverse Wounds

NCT07553689 | Not Yet Recruiting

• 1 other identifier: hzc-01
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wound Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Time to Complete Wound Healing

  From enrollment to complete epithelialization, assessed up to 6 months

• Change in Pain Score (VAS)

  Baseline, day 3, day 7, day 14, day 21, day 28

• Change in Pain Relief/Satisfaction (ASA)

  Baseline, day 3, day 7, day 14, day 21, day 28

• Wound Area Reduction Rate

  Day 7, day 14, day 28

• Scar Assessment

  Month 1, month 3, month 6

Other Outcomes (1)

• Incidence of Adverse Events

  From enrollment to 6 months follow-up

Study Arms (2)

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

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.

Interventions

Plasma Device 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.

Plasma Device Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share