Adjunctive Cold Atmospheric Plasma Therapy for Tracheostomy Wound Healing in Critically Ill Patients: A Pilot Randomised Controlled Trial

ABSTRACT Cold atmospheric plasma (CAP) therapy has emerged as a promising therapy for wound healing. This study aimed to evaluate the feasibility, safety and efficacy of adjunctive CAP therapy for early tracheostomy wound healing compared with standard wound care (SWC) alone. This single‐centre, parallel‐group pilot randomised controlled trial (1:1 allocation) enrolled critically ill patients undergoing tracheostomy. Patients received 1‐min CAP applications on postoperative days 1, 3 and 5 plus SWC or SWC alone. The primary endpoint was the percentage reduction in tracheostomy wound area through postoperative day 7, assessed by a blinded outcome assessor. Due to the nature of the intervention, blinding of participants and treating clinicians was not feasible; however, the outcome assessor was blinded to group allocation. Wound healing trajectories were analysed using linear mixed‐effects models adjusted for baseline wound area. Forty‐two patients were included (CAP, n = 21; SWC, n = 21), with comparable baseline characteristics. By postoperative day 7, wound area reduction was greater in the CAP group than in the SWC group (30.3% vs. 23.6%, p = 0.15). Estimated wound area decreased by 0.08 versus 0.06 cm 2 /day (95% CI 0.06–0.10 and 0.04–0.08, respectively; p = 0.17). No treatment‐related adverse events were observed. Adjunctive CAP therapy was feasible, safe and demonstrated a non‐significant trend towards improved early tracheostomy wound healing. These findings support further evaluation in larger, adequately powered trials.