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

NCT02869204 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-08-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Jens Rikardt Andersen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02869204 on ClinicalTrials.gov