Wound Infection and Wound Healing
Conditions
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%.
Interventions
OTHERLeucocyte - Platelet rich Plasma
Autologous L-PRP are studied regarding it's accelerating effect on tissue repair.
DIETARY_SUPPLEMENTVitamin C
A daily dietary supplement of 500 mg Vitamin C. Provided from POD2-3 until POD30
DIETARY_SUPPLEMENTZinc
A daily dietary supplement of 44 mg Zinc. Provided from POD2-3 until POD30
DIETARY_SUPPLEMENTL-Arginine
A daily dietary supplement of 5 g L-Arginine. Provided from POD2-3 until POD30
Sponsors
Rigshospitalet, Denmark
Jens Rikardt Andersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with wound infection assessed by traditional clinical observation of the cicatrice | 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 . | Infection are defined as a collection of pus in the wound that require revision. It is assessed by observation from the hospital staff. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of days before the surgical wound are full epithelized assessed by observation of the cicatrice | Up to 30 days | Digital photos of the cicatrice will be collected and analyzed for the amount of remaining scab. |
| 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 | — |
| Mobilization assessed by Timed Up & Go (TUG) | Up to 30 days | 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. |
Outcome results
None listed