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Not yet recruiting NCT07553689

Plasma Therapy for Diverse Wounds

— Observational Wound Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma Device.
Who it may be relevant to
Registry conditions: Wound Care. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Interventions

  • 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.

Primary outcome measures

  • Complete Wound Healing Rate at 4 Weeks [Time frame: 4 weeks after enrollment]
  • Proportion of Wounds Achieving ≥50% Area Reduction at 4 Weeks [Time frame: 4 weeks after enrollment]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07553689 · hzc-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗