No registrations found.
ID
Source
Brief title
Health condition
Vitamin c
Vitamine c
Ascorbic acid
Ascorbinezuur
Vascular surgery
Vaatchirurgie
Revascularisation
Revascularisatie
Wound healing
Wond genezing
Fontaine IIb
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improved woundhealing in 30 days in patients with an open revascularisation of the lower extremities after treatment with
4 dosages of 2 grams ascorbic acid on 4 consecutive days. (First dosage 1 hour preoperative)
Secondary outcome
Relation between the ascorbicacid bloodlevel and the reduction in wound surface area of the primary surgical wound 4 weeks post-surgery.
Reduction in wound surface area of a secondary wound (pre-surgical existing) 4 weeks post-surgery (corrected for baseline ascorbicacid level)
Decreasing the incidence of woundinfections of the surgical wound within 30 days post-surgery(corrected for baseline ascorbicacid level)
Reduction of hospital stay (corrected for baseline ascorbicacid level)
Reduction of the number of readmissions within 30 days post-surgery(corrected for baseline ascorbicacid level)
Reduction of the number of 'all cause complications' within 30 days post-surgery (corrected for baseline ascorbicacid level)
Reduction of mortality within 30 days post-surgery (corrected for baseline ascorbicacid level)
Reduction of the time till median wound surface area healing in case the wounds in both groups are fully closed within 30 days post-surgery. (corrected for baseline ascorbicacid level)
Study objective
Intravenously administred ascorbic acid improves reduction in wound area of a vascular surgical wound of at least 30% within 4 weeks post-surgery.
Study design
Time related to surgery
Day -3/-1: Ascorbic acid level (+ secondary wound surface)
Day 0: Preoperative ascorbic acid infusion
Day 0: Surgery
Day 0: Post surgery ascorbic acid level, primary wound surface(+ secondary wound surface)
Day 1: Ascorbic acid infusion
Day 2: Ascorbic acid infusion
Day 1-2: Ascorbic acid level, primary wound surface(+ secondary wound surface)
Day 3: Ascorbic acid infusion
Day 3-4: Ascorbic acid level, primary wound surface(+ secondary wound surface)
Day 10-14: Ascorbic acid level, primary wound surface(+ secondary wound surface)
Day 26-30: Ascorbic acid level, primary wound surface(+ secondary wound surface)
Intervention
Interventiongroup receives 4 administrations of 2000mg ascorbic acid (20ml) intravenously in 4 consecutive days.
Controlgroup receives 4 administrations of NaCl 0.9% (20ml) intravenously in 4 consecutive days.
First dosage in both situaties is given 1 hour preoperative.
J.L.W. Pot
Maatweg 3
Amersfoort 3813TZ
The Netherlands
+31(0)338502363
JLW.Pot@meandermc.nl
J.L.W. Pot
Maatweg 3
Amersfoort 3813TZ
The Netherlands
+31(0)338502363
JLW.Pot@meandermc.nl
Inclusion criteria
Planned open arterial revascularisation on 1 or 2 legs
Age > 18 yrs
Vascular disease fontaine IIb or higher
Exclusion criteria
Age < 18yrs.
Hyperoxaluria.
Patients on dialysis.
Paroxismal nocturnal haemoglobinuria.
G6P deficiency.
Recurrent kidney stones.
Hemochromatosis.
Hemosiderosis.
Usage of deferoxamine (in the past).
Immunological disease.
Pregancy.
Bilateral surgery, other than the revascularisation.
Intolerance for study medication.
Mentally incompetent patients.
Previous participation in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5290 |
| NTR-old | NTR5397 |
| Other | : 2014-005612-41 |