Treatment in the healing of burns with a cold plasma source.
Mario Betancourt-Ángeles, Rosendo Peña-Eguiluz, Régulo López-Callejas...
https://pubmed.ncbi.nlm.nih.gov/29348977Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07382973
Evaluation of Non-Thermal Plasma as an Innovative Strategy for Optimizing Post-Surgical Wound Treatment in Patients of Thyroid Surgery: An Ethical and Clinical Approach
Led by National Institute of Nuclear Research - Mexico · Updated on 2026-02-09
26
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
National Institute of Nuclear Research - Mexico
Lead Sponsor
C
Centro Medico Issemym
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of non-thermal plasma (NTP) to improve wound healing and reduce complications after thyroid surgery. This study focuses on patients undergoing total or subtotal thyroidectomy and aims to see if NTP can speed up tissue repair, lower inflammation and pain, and prevent complications like infections. The safety of helium-based NTP near important neck nerves and blood vessels is also being assessed. Participants are randomly assigned to one of two groups. The experimental group receives a standardized treatment with helium-based NTP applied to the surgical area before closing and then again on the sutured incision. This involves specific exposure times targeting hemostasis, nerve protection, and potential cancer cell removal if needed. The control group receives standard surgical wound care, including routine suturing and dressings, without NTP treatment. Participants will be followed for up to 12 weeks after surgery with regular assessments of wound healing speed, pain levels, inflammation markers, and scar quality. Pain is measured frequently in the first two weeks, and complications are tracked for 28 days. The study also monitors analgesic use and long-term scar outcomes to evaluate NTP's impact on recovery and safety.
CONDITIONS
Brief Title
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosis of thyroid pathology requiring total or subtotal thyroidectomy
- Signed Informed Consent Form (ICF)
- Patients capable of complying with the 12-week follow-up schedule
You will not qualify if you...
- History of previous neck surgery or radiation therapy in the cervical area
- Known history of keloid formation or hypertrophic scarring
- Presence of active systemic or local infection at the time of surgery
- Patients with implanted electronic devices (e.g., pacemakers or defibrillators)
- Pregnancy or breastfeeding
- Concurrent use of systemic corticosteroids or immunosuppressive drugs that may impair wound healing
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery
Duration - Day 0 (day of surgery)
Participants undergo total or partial thyroidectomy with standard surgical wound closure.
1 visit (in-person)
Treatment
Duration - Day 0 (day of surgery)
Participants in the experimental arm receive standardized application of non-thermal plasma (NTP) intraoperatively and postoperatively to the surgical bed and incision to enhance wound healing and oncological control.
Treatment occurs during and immediately after surgery
Post-operative Follow-up
Duration - Up to 12 weeks post-surgery
Participants are monitored for wound healing, pain, and surgical site complications, with assessments continuing up to 12 weeks post-surgery.
Visits at 2, 12, 24, 36, 48, and 72 hours; and on days 7, 14, 21, and 84 post-surgery
Trial Site Locations
Total: 1 location
1
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, Mexico, 52750
Actively Recruiting
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Research Team
L
López-Callejas, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Harnessing Non-Thermal Plasma to Supercharge Recovery in Abdominal Surgeries: A Pilot Study.
Benjamín G Rodríguez-Méndez, Régulo López-Callejas, Antonio Mercado-Cabrera...
https://pubmed.ncbi.nlm.nih.gov/38256546