Skip to content

Vitamin c to Improve Tissue healing by Administration of Multiple INtravenous dosages

Vitamin c to Improve Tissue healing by Administration of Multiple INtravenous dosages - VITAMIN

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41803
Enrollment
40
Registered
2015-12-01
Start date
2016-03-22
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

wound healing

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 consec
Ascorbic acid
Tissue healing
Vascular surgery
Wound healing

Sponsors

Meander Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Age

Design outcomes

Primary

MeasureTime frame
Reduction in woundsurface (%) of the surgical wound 30 days after surgery by intravenous suppletion of ascorbic acid in vascular surgery, with correction for the ascorbic acid level.

Secondary

MeasureTime frame
1. Relation between the ascorbicacid bloodlevel and the reduction in wound surface area of the primary surgical wound 4 weeks post-surgery. 2. Reduction in wound surface area of a secondary wound (pre-surgical existing) 4 weeks post-surgery (corrected for baseline ascorbicacid level) 3. Decreasing the incidence of woundinfections of the surgical wound within 30 days post-surgery(corrected for baseline ascorbicacid level) 4. Reduction of hospital stay (corrected for baseline ascorbicacid level) 5. Reduction of the number of readmissions within 30 days postsurgery(corrected for baseline ascorbicacid level) 6. Reduction of the number of 'all cause complications' within 30 days postsurgery(corrected for baseline ascorbicacid level) 7. Reduction of mortality within 30 days post-surgery (corrected for baseline ascorbicacid level) 8. 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)

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)