search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Vitamin c to improve wound healing after vascular surgery


- candidate number22851
- NTR NumberNTR5397
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2015
- Secondary IDs2014-005612-41 
- Public TitleVitamin c to improve wound healing after vascular surgery
- Scientific TitleVitamin c to improve tissue healing by administration of multiple intravenous dosages
- ACRONYMVITAMIN
- hypothesisIntravenously administred ascorbic acid improves reduction in wound area of a vascular surgical wound of at least 30% within 4 weeks post-surgery.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaPlanned open arterial revascularisation on 1 or 2 legs
Age > 18 yrs
Vascular disease fontaine IIb or higher
- Exclusion criteriaAge < 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate30-sep-2016
- Target number of participants40
- InterventionsInterventiongroup 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.
- Primary outcomeImproved 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 outcomeRelation 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)
- TimepointsTime 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)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. ing. J.L.W. Pot
- CONTACT for SCIENTIFIC QUERIESDrs. ing. J.L.W. Pot
- Sponsor/Initiator Meander Medical Center Amersfoort
- Funding
(Source(s) of Monetary or Material Support)
Meander Medical Center Amersfoort
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-sep-2015 - 17-okt-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl