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

NCT02869204 | Unknown

• 1 other identifier: H-16025526
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of days before the surgical wound are full epithelized assessed by observation of the cicatrice

  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)"

  Up to 30 days

Study Arms (2)

Leucocyte - Platelet rich Plasma and Dietary Supplements

EXPERIMENTAL

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; Dietary Supplement: Vitamin C; Dietary Supplement: Zinc; Dietary Supplement: L-Arginine

Treatment as usual

NO INTERVENTION

Patients are treated as usual.

Interventions

Leucocyte - Platelet rich Plasma OTHER

Autologous L-PRP are studied regarding it's accelerating effect on tissue repair.

Also known as: L-PRP

Leucocyte - Platelet rich Plasma and Dietary Supplements

Vitamin C DIETARY_SUPPLEMENT

A daily dietary supplement of 500 mg Vitamin C. Provided from POD2-3 until POD30

Leucocyte - Platelet rich Plasma and Dietary Supplements

Zinc DIETARY_SUPPLEMENT

A daily dietary supplement of 44 mg Zinc. Provided from POD2-3 until POD30

Leucocyte - Platelet rich Plasma and Dietary Supplements

L-Arginine DIETARY_SUPPLEMENT

A daily dietary supplement of 5 g L-Arginine. Provided from POD2-3 until POD30

Leucocyte - Platelet rich Plasma and Dietary Supplements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Rikardt Andersen: lead
• Rigshospitalet, Denmark: collaborator

MeSH Terms

Conditions

Wound Infection

Interventions

Ascorbic Acid; Zinc; Arginine

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 16, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08