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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the use of non-thermal plasma NTP as an additional treatment during standard surgical drainage for adults with symptomatic chronic subdural hematoma cSDH. This randomized controlled trial aims to determine if applying NTP during surgery can reduce the recurrence rate of cSDH within six months, assess the safety of NTP in the surgical area, and evaluate its effects on functional recovery and the speed of hematoma resolution. Participants undergo either standard surgery alone or standard surgery combined with intraoperative NTP application. The NTP is generated by a device using helium gas and applied sequentially to the exposed dura mater, residual membranes, soft tissue layers, and skin incision during surgery. Both groups receive the same standard perioperative care, including antibiotics and pain management. Follow-up visits occur at one week, three months, and six months post-surgery. During follow-up, clinical assessments include neurological scales such as the Glasgow Coma Scale and Modified Rankin Scale, along with head CT scans to monitor hematoma status. The main outcome measured is recurrence of the hematoma, defined by symptoms requiring re-intervention or significant volume increase on CT. Secondary outcomes include time to radiological resolution, changes in functional status, and safety through adverse event monitoring. Participation lasts for six months post-surgery.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are evaluating the effectiveness and safety of a new hydrogel made from Carbopol40 neutralized to pH 5.5 and combined with Plasma-Activated Water PAW for treating chronic wounds. These wounds include diabetic foot ulcers, pressure injuries, surgical wound dehiscence, and arterial or venous ulcers that have not healed for more than three months. The study aims to see if the PAW-hydrogel speeds up wound closure, reduces bacteria in the wound, and is safe and well-tolerated compared to standard advanced wound care. Participants will be randomly assigned to one of two groups. The experimental group will receive topical applications of the PAW-hydrogel 2 to 3 times a week after wound cleaning with sterile saline. The hydrogel is applied as a uniform layer covering the entire wound and covered with a sterile dressing. The control group will receive the usual advanced wound care including cleaning, mechanical debridement if needed, and conventional dressings without the PAW-hydrogel. Treatments continue for up to 12 weeks or until the wound fully closes. During the 12-week follow-up, participants will be assessed weekly for wound area reduction and bacterial load at specific intervals. Other evaluations include pain levels recorded at each treatment visit, wound tissue quality assessments, and monitoring for any treatment-related side effects. The number of dressing changes and overall safety will also be tracked. Participants provide informed consent and may leave the study at any time without affecting their medical care.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

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 NTPs impact on recovery and safety.

Age: 18Years +All GendersPhase Not Applicable
1 location