A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
Despite modern aseptic precautions, surgical site infection remains a significant problem. Although the benefits of negative pressure wound therapy in the treatment of chronic wounds are well established, high-level evidence is still lacking on the potential role of negative pressure in the prevention of surgical site infections. We conducted a multicenter, randomised, prospective trial of closed incision vacuum therapy. A total of 90 general surgery patients undergoing emergency laparotomy were enrolled and randomised, 45 cases in the treatment group and 45 cases in the control group. Our aim was to show a significant difference in the rate of surgical site infection between the two groups. In the study group, laparotomy wounds were treated with a single 5-day course of prophylactic vacuum therapy, whereas the control group underwent conventional postoperative wound management with sterile gauze dressings. Ten of the 45 patients in the study group developed a surgical site infection compared to 20 of 45 in the control group (22.2% vs. 44.4% p = 0.025). Upon further analysis, the proportion of superficial SSIs was found to be significantly lower in the ciNPWT group (40% vs. 20% p = 0.038), whereas the difference in deep SSI rates was not statistically significant (4.4% vs. 4.4% p = 1.0). In conclusion, negative pressure wound therapy is not only an effective way to heal chronic wounds, but it's prophylactic use may reduce the overall rate of surgical site infections.
Trial Registration: Clinicaltrials.gov: NCT03716687
Endotracheal intubation is a crucial intervention for mechanically ventilated patients in the intensive care unit (ICU). However, the presence of the tube and bite block in the mouth significantly raises the risk of mucosal pressure injuries (MMPI) and other oral complications. These complications not only compromise oral health but also prolong hospitalisation and increase medical costs. Despite advances in airway management, effective solutions to mitigate these risks remain limited. Few studies have explored reducing mucosal pressure and improving oral health by optimising the design and reducing the volume of oral devices. Therefore, this study aimed to design and evaluate a novel nested tracheal tube device to reduce oral MMPI and improve oral health outcomes in intubated patients. A prospective, non-blinded, randomised, parallel-controlled intervention study was conducted, involving 151 patients who were intubated for more than 48 h. Participants were randomly assigned into two groups: the intervention group (n = 75), which received the novel nested tracheal tube device, and the control group (n = 76), which received the standard endotracheal tube with bite block. The primary outcome measure was the incidence of MMPI. Secondary outcomes included the Beck Oral Health Score, plaque index, ventilator-associated pneumonia (VAP) and costs. Compared to the standard group, the nested tracheal tube group showed a significant reduction in MMPI (χ 2 = 8.796, p < 0.05). In addition, the nested tracheal tube group demonstrated significantly better outcomes in Beck Oral Health Scores (Z = −2.948, p < 0.05) and plaque index (Z = −2.010, p < 0.05), indicating improvements in oral function and hygiene. However, there were no significant differences between the two groups in VAP incidence and average daily ICU costs (p > 0.05). The nested tracheal tube effectively reduces localised pressure on oral tissues and improves oral function, offering a practical solution to mitigate MMPI in mechanically ventilated patients and enhance their oral health outcomes.