Wound Infection and Wound HealingNCT02869204
The Effect of a Local Injection of a Platelet Concentrate on Infection and Healing of Surgical Wounds
A study testing Leucocyte - Platelet rich Plasma, Vitamin C and Zinc in people with Wound Infection and Wound Healing, run by Jens Rikardt Andersen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection and Wound Healing
- What is being tested?
- Leucocyte - Platelet rich Plasma, Vitamin C and Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: The Effect of L-PRP on Wound Healing and Wound Infection After Pancreaticoduodenectomy / Whipples Surgery
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.
Read more
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
- Being tested
- Leucocyte - Platelet rich Plasma, Vitamin C, Zinc, L-Arginine
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucocyte - Platelet rich PlasmaOther
Also called L-PRP
Autologous L-PRP are studied regarding it's accelerating effect on tissue repair.
Vitamin CDietary supplement
A daily dietary supplement of 500 mg Vitamin C. Provided from POD2-3 until POD30
ZincDietary supplement
A daily dietary supplement of 44 mg Zinc. Provided from POD2-3 until POD30
L-ArginineDietary supplement
A daily dietary supplement of 5 g L-Arginine. Provided from POD2-3 until POD30
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Digital photos of the cicatrice will be collected and analyzed for the amount of remaining scab.
Measured: Up to 30 days
Other postoperative complications
Measured: Up to 30 days
Length of stay (LOS)
Measured: 30 days
Experience of pain assessed by a VAS (Visual analogue scale)
Measured: Up to 30 days
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.
Measured: Up to 30 days
Inflammatory responds assessed by blood sample analysis of the acute phase reactant CRP (c-reactive protein)
Measured: Up to 30 days
Inflammatory responds assessed by blood sample analysis of the acute phase reactant leucucytes
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection and Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869204
- Sponsor's protocol ID
- H-16025526
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of L-PRP on Wound Healing and Wound Infection After Pancreaticoduodenectomy / Whipples Surgery
- ClinicalTrials.gov ID
- NCT02869204
- Acronym / sponsor ID
- H-16025526
- Conditions
- Wound Infection and Wound Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucocyte - Platelet rich Plasma and Dietary Supplements | Experimental | Other: Leucocyte - Platelet rich Plasma, Dietary Supplement: Vitamin C, Dietary Supplement: Zinc, Dietary Supplement: L-ArginineAn 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 as usual | No intervention | –Patients are treated as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucocyte - Platelet rich PlasmaAlso: L-PRPAutologous L-PRP are studied regarding it's accelerating effect on tissue repair. | Other | Leucocyte - Platelet rich Plasma and Dietary Supplements |
| Vitamin CA daily dietary supplement of 500 mg Vitamin C. Provided from POD2-3 until POD30 | Dietary supplement | Leucocyte - Platelet rich Plasma and Dietary Supplements |
| ZincA daily dietary supplement of 44 mg Zinc. Provided from POD2-3 until POD30 | Dietary supplement | Leucocyte - Platelet rich Plasma and Dietary Supplements |
| L-ArginineA daily dietary supplement of 5 g L-Arginine. Provided from POD2-3 until POD30 | Dietary supplement | Leucocyte - Platelet rich Plasma and Dietary Supplements |
Primary outcome
Number of patients with wound infection assessed by traditional clinical observation of the cicatrice
Time frame: 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.
7 secondary outcomes
Number of days before the surgical wound are full epithelized assessed by observation of the cicatrice
Time frame: Up to 30 days
Other postoperative complications
Time frame: Up to 30 days
Length of stay (LOS)
Time frame: 30 days
Experience of pain assessed by a VAS (Visual analogue scale)
Time frame: Up to 30 days
Mobilization assessed by "Timed Up & Go (TUG)"
Time frame: Up to 30 days
Inflammatory responds assessed by blood sample analysis of the acute phase reactant CRP (c-reactive protein)
Time frame: Up to 30 days
Inflammatory responds assessed by blood sample analysis of the acute phase reactant leucucytes
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Leucocyte - Platelet rich Plasma, Vitamin C and Zinc in people with Wound Infection and Wound Healing, run by Jens Rikardt Andersen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with wound infection assessed by traditional clinical observation of the cicatrice (time frame: 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 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.