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
Qualifiers
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 design
Treatments tested in this trial
- Plasma Device
Treatment groups
1,000 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov