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
Not Applicable
- Conditions
- Injury, poisoning and certain other consequences of external causes
- Registration Number
- KCT0007698
- Lead Sponsor
- Hanyang University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 26
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bluebelle Wound Healing Questionnaire(Bluebelle WHQ) assessment
- Secondary Outcome Measures
Name Time Method 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