The Effect of L-PRP on Wound Healing and Wound Infection After Pancreaticoduodenectomy / Whipples Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Number of patients with wound infection assessed by traditional clinical observation of the cicatrice
研究概览
简要总结
The purpose of this project is to investigate whether a combination of a local injection of platelet rich plasma (PRP) combined with a daily supplement of vitamin C, zinc, L-arginine, as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote tissue healing in patients undergoing open upper-abdominal surgery.
Primary endpoint is cases of wound infection and secondary endpoints are time of tissue regeneration (days), judged by traditional clinical observation and experimentally assessed by ultrasound.
The experiment is performed as a parallel two-armed, randomized, controlled trial.
A total of 40 subjects will be included in the trial i order to ensure the power of the study, despite a drop off of up to 25%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at Rigshospitalets Surgical gastroenterology clinic
- •Planned to have a Pancreaticoduodenectomy preformed
- •Being able to understand Danish, the trial and what it means to be enrolled in the trial
- •Capable of signing a written consent
- •Living i the Regional Capital (excl. Bornholm) or the Regional of Sjælland (north of Næstved)
排除标准
- •Dysregulated diabetes mellitus type I or II
- •Alcohol consumption above 14 or 7 x 12 g alcohol per week (men vs women)
- •Participating in another clinical trial
研究组 & 干预措施
Treatment as usual
Patients are treated as usual.
Leucocyte - Platelet rich Plasma and Dietary Supplements
An application of an autologous platelet concentrate (20 ml). This is injected once, locally in the muscle after closure of the inner fascia and before closure of the outer fascia.
A daily dietary supplement of Vitamin C, Zinc and L-Arginine. Provided from POD2-3 until POD30
干预措施: Leucocyte - Platelet rich Plasma (Other)
Leucocyte - Platelet rich Plasma and Dietary Supplements
An application of an autologous platelet concentrate (20 ml). This is injected once, locally in the muscle after closure of the inner fascia and before closure of the outer fascia.
A daily dietary supplement of Vitamin C, Zinc and L-Arginine. Provided from POD2-3 until POD30
干预措施: L-Arginine (Dietary Supplement)
Leucocyte - Platelet rich Plasma and Dietary Supplements
An application of an autologous platelet concentrate (20 ml). This is injected once, locally in the muscle after closure of the inner fascia and before closure of the outer fascia.
A daily dietary supplement of Vitamin C, Zinc and L-Arginine. Provided from POD2-3 until POD30
干预措施: Zinc (Dietary Supplement)
Leucocyte - Platelet rich Plasma and Dietary Supplements
An application of an autologous platelet concentrate (20 ml). This is injected once, locally in the muscle after closure of the inner fascia and before closure of the outer fascia.
A daily dietary supplement of Vitamin C, Zinc and L-Arginine. Provided from POD2-3 until POD30
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Number of patients with wound infection assessed by traditional clinical observation of the cicatrice
时间窗: From date of surgery until the date of first documented event of infection or date of death from any cause, whichever came first, assessed up to 30 days .
Infection are defined as a collection of pus in the wound that require revision. It is assessed by observation from the hospital staff.
次要结局
- Number of days before the surgical wound are full epithelized assessed by observation of the cicatrice(Up to 30 days)
- Other postoperative complications(Up to 30 days)
- Inflammatory responds assessed by blood sample analysis of the acute phase reactant leucucytes(Up to 30 days)
- Length of stay (LOS)(30 days)
- Experience of pain assessed by a VAS (Visual analogue scale)(Up to 30 days)
- Mobilization assessed by "Timed Up & Go (TUG)"(Up to 30 days)
- Inflammatory responds assessed by blood sample analysis of the acute phase reactant CRP (c-reactive protein)(Up to 30 days)
研究者
Jens Rikardt Andersen
Associate Professor, MD
University of Copenhagen