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Exploratory clinical trial to evaluate the efficacy and safety of skin regeneration and wound healing effects when a cold plasma device Plamedicine is applied to surgical wound patients

Exploratory clinical trial to evaluate the efficacy and safety of skin regeneration and wound healing effects when a cold plasma device Plamedicine is applied to surgical wound patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007698
Enrollment
26
Registered
2022-09-16
Start date
2022-09-01
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : (1) Subjects who have agreed to participate in the trial are assigned 1:1 into the control group and the test group through randomization. ? Control group: 13 pat

Sponsors

Hanyang University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Patients 19 years of age or older who are expected to undergo cesarean section * Surgical range: patient within 15cm X 10cm 2) A person who understands the purpose of this clinical trial and is willing to comply with the clinical trial protocol with a voluntary decision to participate

Exclusion criteria

Exclusion criteria: 1) Those with gestational diabetes 2) Those with comorbidities that may affect wound healing (malignant tumors, vasculitis, connective tissue disease) 3) Patients with clinical infection, those who are immunosuppressed 4) Those who are taking treatment (drugs, ointments, etc.) that may affect wound healing (e.g. steroids, aspirin, etc.) 5) Others judged by the investigator as unsuitable to participate in the clinical trial

Design outcomes

Primary

MeasureTime frame
Bluebelle Wound Healing Questionnaire(Bluebelle WHQ) assessment

Secondary

MeasureTime frame
VAS(10cm Visual Analog Scale) assessment;Confirmation of exudate, re-epithelialization, and proliferation of granulation tissue at the surgical wound site in control group and test group;The number of days it took for the wound at the cesarean section to heal (wound healing period);Overall satisfaction of participants regarding the Investigational medical device;Adverse events / Serious adverse events

Countries

Korea, Republic of

Contacts

Public ContactKi-Young Ryu

Hanyang University

drryuky@hanmail.net+82-31-560-2344

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026