Intravenously administred ascorbic acid improves reduction in wound area of a vascular surgical wound of at least 30% within 4 weeks post-surgery.
ID
Bron
Verkorte titel
Aandoening
Vitamin c
Vitamine c
Ascorbic acid
Ascorbinezuur
Vascular surgery
Vaatchirurgie
Revascularisation
Revascularisatie
Wound healing
Wond genezing
Fontaine IIb
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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)
Doel van het onderzoek
Intravenously administred ascorbic acid improves reduction in wound area of a vascular surgical wound of at least 30% within 4 weeks post-surgery.
Onderzoeksopzet
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)
Onderzoeksproduct en/of interventie
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.
Publiek
J.L.W. Pot
Maatweg 3
Amersfoort 3813TZ
The Netherlands
+31(0)338502363
JLW.Pot@meandermc.nl
Wetenschappelijk
J.L.W. Pot
Maatweg 3
Amersfoort 3813TZ
The Netherlands
+31(0)338502363
JLW.Pot@meandermc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Planned open arterial revascularisation on 1 or 2 legs
Age > 18 yrs
Vascular disease fontaine IIb or higher
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5290 |
| NTR-old | NTR5397 |
| Ander register | : 2014-005612-41 |