Vitamin c to improve wound healing after vascular surgery

Vitamin c to improve tissue healing by administration of multiple intravenous dosages

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21212

Enrollment

Registered

2015-09-09

Start date

2015-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin c Vitamine c Ascorbic acid Ascorbinezuur Vascular surgery Vaatchirurgie Revascularisation Revascularisatie Wound healing Wond genezing Fontaine IIb

Interventions

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 consecu

Eligibility

Inclusion criteria

Inclusion criteria: Planned open arterial revascularisation on 1 or 2 legs Age > 18 yrs Vascular disease fontaine IIb or higher

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

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Contacts

Public ContactJ.L.W. Pot

Meander Medisch Centrum - Klinische Farmacie

JLW.Pot@meandermc.nl+31(0)338502363

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)