NCT02869204

The Effect of a Local Injection of a Platelet Concentrate on Infection and Healing of Surgical Wounds

The Effect of L-PRP on Wound Healing and Wound Infection After Pancreaticoduodenectomy / Whipples Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jens Rikardt Andersen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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%.

Conditions

• Wound Infection and Wound Healing

Interventions

Type	Name	Description
OTHER	Leucocyte - Platelet rich Plasma	Autologous L-PRP are studied regarding it's accelerating effect on tissue repair.
DIETARY_SUPPLEMENT	Vitamin C	A daily dietary supplement of 500 mg Vitamin C. Provided from POD2-3 until POD30
DIETARY_SUPPLEMENT	Zinc	A daily dietary supplement of 44 mg Zinc. Provided from POD2-3 until POD30
DIETARY_SUPPLEMENT	L-Arginine	A daily dietary supplement of 5 g L-Arginine. Provided from POD2-3 until POD30

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-02-01
• First posted: 2016-08-16
• Last updated: 2016-08-16