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

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%.

Study Overview

• Status: Unknown
• Conditions: Wound Infection and Wound Healing
• Intervention / Treatment: Other: Leucocyte - Platelet rich Plasma; Dietary supplement: Vitamin C; Dietary supplement: Zinc; Dietary supplement: L-Arginine

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Leucocyte - Platelet rich Plasma; Autologous L-PRP are studied regarding it's accelerating effect on tissue repair.; Other Names: L-PRP; 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
No Intervention: Treatment as usual; Patients are treated as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with wound infection assessed by traditional clinical observation of the cicatrice	Infection are defined as a collection of pus in the wound that require revision. It is assessed by observation from the hospital staff.	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 .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days before the surgical wound are full epithelized assessed by observation of the cicatrice	Digital photos of the cicatrice will be collected and analyzed for the amount of remaining scab.	Up to 30 days
Other postoperative complications		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)"	Timed Up & Go, also known as TUG, measures the time it takes a study subject to stand up, walk 3 meters, turn around, walk back and sit down.	Up to 30 days
Inflammatory responds assessed by blood sample analysis of the acute phase reactant CRP (c-reactive protein)		Up to 30 days
Inflammatory responds assessed by blood sample analysis of the acute phase reactant leucucytes		Up to 30 days

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Collaborators: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: H-16025526