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

Jens Rikardt Andersen40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Wound Infection and Wound Healing

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: Up to 30 days