Adjuvant Use of Autologous Platelet-rich Fibrin Glue in the Treatment of Fistulas and Anastomotic Leakages of the Digestive Tract
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- counting time from enrollment or glue application to fistula closure or healing (d)
研究概览
简要总结
Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.
详细描述
The sudden appearance of intestinal contents draining from an abdominal incision is an emotionally devastating experience for both patients and surgeons. An enterocutaneous fistulas (ECF) is an abnormal communication between the bowel lumen and skin, often associated with fluid and electrolyte abnormalities, malnutrition, and sepsis. It is reported that spontaneous fistula closure rates vary from 15% to 71% after conservative treatment with wound care, control of infection, and nutritional support. Sufficient time should be allotted for the ECF to heal with conservative treatment, which also results in long-term discomfort.
Adjuvant use of fibrin glue (FG) in the fistula tract may promote healing in low-output ECF. Containing high concentrations of human fibrinogen and thrombin, FG have been used extensively in many surgical fields as a biological adhesive system for tissue adhesion or hemostasis. Different types of FG are now employed: commercially produced and homemade autologous adhesives. Currently available FDA-approved commercial products such as Tisseel, Artiss (Baxter, Westlake Village, CA, USA), and Evicel (Johnson & Johnson, Somerville, NJ, USA) are widely used in clinical applications. Risks of infection transmission, allergic reactions, and also the high cost, however, still make autologous FG attractive. Additionally, in comparison with other adhesives, autologous compounds have several advantages in terms of biocompatibility and biodegradation.
The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years
- •presence of one or more fistulas
- •fistulas of low-output volume (< 200ml/24h)
排除标准
- •failure to meet inclusion criteria
- •mental handicap
- •extreme thinness
- •fistulous tract length < 2 cm
- •fistulous tract diameter > 1 cm
- •entero-atmospheric fistulas
- •Crohn's disease-related fistulas
- •any conditions that might impede spontaneous closure of the fistula, such as complex tracts, associated abscesses, residual disease, foreign bodies or distal obstruction
- •any conditions that might increase the risk of auto-transfusion, including hypertension, or diabetes; and acquired immune deficiency syndrome (AIDS)
研究组 & 干预措施
conservative therapy
Conservative therapy includes orrection of electrolytic disturbances, suppression of gastric/intestinal secretion with octreotide, nutritional support.
干预措施: Octreotide (Drug)
Application of autologous PRFG
The application of the glues through the external opening of the fistula was controlled by the drainage tube, which was based on fistulography to assure total occlusion of the internal hole. To allow the adhesion of the fibrin glues patch, all fistulous tracts were debrided to produce a smooth surface. At the time of procedures, the two components were mixed together to yield a gelatinous substance. After the FG was instilled, any redundant glue was removed from the external openings.
干预措施: Autologous platelet-rich fibrin glue (PRFG) (Procedure)
Application of autologous PRFG
The application of the glues through the external opening of the fistula was controlled by the drainage tube, which was based on fistulography to assure total occlusion of the internal hole. To allow the adhesion of the fibrin glues patch, all fistulous tracts were debrided to produce a smooth surface. At the time of procedures, the two components were mixed together to yield a gelatinous substance. After the FG was instilled, any redundant glue was removed from the external openings.
干预措施: Octreotide (Drug)
结局指标
主要结局
counting time from enrollment or glue application to fistula closure or healing (d)
时间窗: 1-90 days
The primary measures were defined as the time required for fistula closure and also fistula healing after the last treatment received if in study group, or since enrollment if in control group. Closure was predefined as the absence of drainage through the external openings whether occurring spontaneously or under externally applied pressure. Healing was predefined as complete reepithelialization of external openings.
次要结局
- counting time from enrollment or glue application to enteral intake (d)(1-90 days)
研究者
Jianan Ren
Clinical professor, Principal investigator
Jinling Hospital, China