NCT06984107尚未招募不适用
Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Clinical wound healing (modified Landry Healing Index)
研究概览
简要总结
Several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of MRONJ. Supportive therapies are therefore needed to help tissues wound healing. The primary objective of this pilot clinical case series is to evaluate the post-operative wound healing in a group of patients undergoing surgical therapy for MRONJ with intraoperative application of a gel based on polynucleotides and hyaluronic acid (PN+HA) (Regenfast®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Provided informed consent
- •MRONJ stage 1 and stage 2 diagnosis, in accordance to SICMF-SIPMO classification
- •Need to undergo surgical treatment of MRONJ
排除标准
- •Patients with history of head and neck radiotherapy
- •Neurological and psychiatric conditions
- •Pregnancy
- •MRONJ stage 3 diagnosis
- •Patients who will receive a re-treatment for MRONJ
- •Patients with general contraindication for oral surgery
- •Patients unable to attend the out-patients visits scheduled by the protocol
结局指标
主要结局
Clinical wound healing (modified Landry Healing Index)
时间窗: 12 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
次要结局
未报告次要终点
研究者
相似试验
撤回
不适用
Intraoperative Evaluation Using ICG and SPY Fluorescence to Prevent Wound Complications in Head and Neck Surgery.Head and Neck CancerNCT03345732University Health Network, Toronto
已完成
不适用
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted GastrectomyGastric CancerGastrostomyNCT03960775Yonsei University84
已完成
不适用
Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer?s maleate vs G5-K solutioISRCTN32976792Bern University Hospital (Switzerland)44
已完成
2 期
Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal CancerSurgeryNCT01218841University of Sao Paulo85
尚未招募
不适用
Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant SurgeryLiver TransplantHemorrhage, SurgicalNCT06357455Eduardo Schiffer40