Efficacy of autologous platelet-rich plasma gel in patients with hard-to-heal diabetic foot ulcers: a multicentre study in Japan.

OBJECTIVE: To evaluate the healing outcome of a platelet-rich plasma (PRP) gel prepared using TKKT01 (a wound care device to prepare the PRP gel) in patients with hard-to-heal diabetic foot ulcers (DFUs) and who showed an inadequate response to ≥4 weeks of standard of care (SoC). METHOD: This open-label, single-arm, multicentre study was conducted in 15 centres in Japan. Eligible patients received PRP gel treatment twice a week for eight weeks, followed by a final evaluation after the completion of week 8 (day 57). The primary endpoint was the percentage of patients who achieved ≥50% reduction in wound radius at the final evaluation (achievement criterion, ≥60% of patients). Secondary endpoints included: wound area and volume reduction rates; time to possible wound closure by secondary intention; time to possible wound closure using a relatively simple procedure (e.g., skin graft and suture); and safety at the final evaluation. RESULTS: A total of 54 patients were included in the full analysis set, with 47 patients included in the per protocol set; the primary endpoint was met in 38/47 (80.9%) (95% confidence interval: 66.7-90.9%) patients who achieved ≥50% wound radius reduction at the final evaluation. High rates of wound area (72.8%) and volume (92.7%) reduction were observed at the final evaluation. The median time to possible wound closure by secondary intention and by use of a relatively simple procedure was 57 and 43 days, respectively. Complete wound closure at the final evaluation was achieved in 27 (57.4%) patients. No safety concerns were raised. CONCLUSION: In this study, the efficacy and safety of PRP gel treatment with TKKT01 in patients with hard-to-heal DFUs in Japan were confirmed by our findings. DECLARATION OF INTEREST: This study was funded by Rohto Pharmaceutical Co., Ltd., Japan. NO has been paid a consulting fee by Rohto Pharmaceutical Co., Ltd. KH is the Chief Medical Officer of Rohto Pharmaceutical. Co., Ltd. The other authors have no conflict of interest to declare.

A Simple and Reliable Submental Intubation Technique for Maxillofacial Fractures.

In 1986, Altemir first reported the use of submental intubation to avoid tracheotomy in patients with panfacial and midfacial fractures for whom intermaxillary fixation is necessary, but orotracheal and nasotracheal intubations are not recommended. This novel technique allowed intraoperative access to perform dental occlusion and reconstruction of the nasal pyramid in patients with skull base fractures. Herein, we describe a refined technique based on Altemir's original procedure. Seven male patients with panfacial fractures underwent submental intubation using our refined technique. The technique was developed after encountering a technical error with Altemir's original procedure. In this new technique, we employed a 2-0 silk suture guide to allow the passage of both the endotracheal and cuff-inflation tubes through the same tunnel created from the oral cavity to the submental area. The success rate of the refined technique was 100%, and there were no intraoperative or postoperative complications. There was 20 seconds of ventilation outage time in total. Endotracheal and cuff-inflation tubes were easily and quickly passed through the same submental tunnel. Our refined technique is simple, easy, safe, fast, inexpensive, and does not require specific materials. Submental scars were smaller and relatively inconspicuous in this study, compared to those reportedly associated with other modified techniques.