Preliminary Clinical Study Using a Novel Wound Dressing Composed of Hyaluronic Acid and Collagen Containing EGF

This clinical trial aimed to evaluate the efficacy and safety of a novel wound dressing composed of hyaluronic acid (HA) and collagen (Col) containing epidermal growth factor (EGF), referred to as EGF-wound dressing. EGF-wound dressing was prepared by freeze-drying a mixed aqueous solution of high-molecular-weight HA, low-molecular-weight HA and heat-denatured Col containing EGF. EGF-wound dressing was applied to skin defects, such as intractable skin ulcers, burn ulcers, traumatic skin defects and skin donor-site wounds. The dressing was changed twice a week for a period of 6 weeks or longer, if necessary. The primary endpoints were size of wound area, formation of granulation tissue, extent of epithelialization, infection control and macroscopic appearance. Effectiveness, safety and overall clinical evaluation were scored by plastic surgeons, as authorized by the Japanese Society of Plastic and Reconstructive Surgery. This study was registered with the University Hospital Medical Information Network (UMIN0000005264). Healthy granulation tissue and rapid epithelialization were observed for a given period after application of EGF-wound dressing onto the wounds. Most cases were assessed as having achieved good or excellent results. This clinical study demonstrated that EGF-wound dressing was beneficial in the treatment of various skin defects.

Association of antithrombotic therapy with postoperative rebleeding in patients with cerebral amyloid angiopathy

Background Cerebral amyloid angiopathy is a common cause of subcortical hemorrhage in older adults.Although open hematoma removal may be performed for severe subcortical hemorrhage,its safety in patients with cerebral amyloid angiopathy has not been established,and postoperative rebleeding may occur.Therefore,this study aimed to investigate factors associated with postoperative rebleeding.Methods Out of 145 consecutive patients who had undergone craniotomy for surgical removal of subcortical intracerebral hemorrhage between April 2010 and August 2019 at a single institution in Japan,we examined 109 patients with subcortical hemorrhage who met the inclusion criteria.After excluding 30 patients whose tissue samples were unsuitable for the study,the final study cohort comprised 79 patients.Results Of the 79 patients,50(63%)were diagnosed with cerebral amyloid angiopathy(cerebral amyloid angiopathy group)and 29(37%)were not diagnosed with noncerebral amyloid angiopathy(noncerebral amyloid angiopathy group).Postoperative rebleeding occurred in 12 patients(24%)in the cerebral amyloid angiopathy group and in 2 patients(7%)in the noncerebral amyloid angiopathy group.Preoperative prothrombin time-international normalized ratio and intraoperative bleeding volume were significantly associated with postoperative rebleeding in the cerebral amyloid angiopathy group(odds ratio=42.4,95%confidence interval=1.14-1578;p=0.042 and odds ratio=1.005,95%confidence interval=1.001-1.008;p=0.007,respectively).Conclusions Patients with cerebral amyloid angiopathy-related cerebral hemorrhage who are receiving antithrombotic therapy,particularly warfarin therapy,are at a high risk of postoperative rebleeding.Trial registration Registry and Registration Number of the study:19-220,2019/12/23,retrospectively registered.