Vitamin c to improve wound healing after vascular surgery

• Conditions: Patients with planned revascularisation surgery on the lower extremities.; MedDRA version: 18.1Level: LLTClassification code 10003451Term: Ascorbic acidSystem Organ Class: 100000004848; MedDRA version: 18.1Level: LLTClassification code 10063919Term: Bypass surgerySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10036892Term: Promotion of wound healingSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: LLTClassification code 10061407Term: Vascular bypass graftSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: LLTClassification code 10053375Term: Peripheral revascularizationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-005612-41-NL
• Lead Sponsor: Meander Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-17
• Last Update Posted: 14 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the effect of intravenously administered dosages of ascorbic acid on wound healing in patients with open revascularisation of the lower extremities.;Secondary Objective: Evaluation of the effect of intravenously administered dosages of ascorbic acid on secondary wound healing (pre-surgical existing ulcers) post-surgical complications, mortality and duration of hospital stay.;Primary end point(s): Improved reduction in wound area of the vascular surgical wound of at least 30%. (corrected for ascorbineacid bloodlevel);Timepoint(s) of evaluation of this end point: 4 weeks post-surgery.