Wound Infection and Wound Healing Clinical Trial
Official title:
The Effect of L-PRP on Wound Healing and Wound Infection After Pancreaticoduodenectomy / Whipples Surgery
| Verified date | August 2016 |
| Source | University of Copenhagen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: The National Research Ethics Committee |
| Study type | Interventional |
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%.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Jens Rikardt Andersen | Rigshospitalet, Denmark |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 . | No |
| Secondary | 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. | Up to 30 days | No |
| Secondary | Other postoperative complications | Up to 30 days | No | |
| Secondary | Length of stay (LOS) | 30 days | No | |
| Secondary | Experience of pain assessed by a VAS (Visual analogue scale) | Up to 30 days | No | |
| Secondary | Mobilization assessed by "Timed Up & Go (TUG)" | 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. | Up to 30 days | No |
| Secondary | Inflammatory responds assessed by blood sample analysis of the acute phase reactant CRP (c-reactive protein) | Up to 30 days | No | |
| Secondary | Inflammatory responds assessed by blood sample analysis of the acute phase reactant leucucytes | Up to 30 days | No |