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

Jens Rikardt Andersen

Status: Unknown

Conditions: Wound Infection and Wound Healing

Treatments: Dietary Supplement: L-Arginine; Dietary Supplement: Vitamin C; Other: Leucocyte - Platelet rich Plasma; Dietary Supplement: Zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT02869204

H-16025526

Details and patient eligibility

About

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%.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Leucocyte - Platelet rich Plasma and Dietary Supplements

Experimental group

Description:

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

Treatment:

Dietary Supplement: Zinc

Other: Leucocyte - Platelet rich Plasma

Dietary Supplement: L-Arginine

Dietary Supplement: Vitamin C

Treatment as usual

No Intervention group

Description:

Patients are treated as usual.