None listed
Conditions
Brief summary
this study is being performed because patients are admitted to hospital for the treatment of Cellulitis. Cellulitis is a skin infection usually caused by a type of bacteria entering the skin, usually by way of a cut, abrasion, or break in the skin. This break does not need to be visible. The typical symptoms of Cellulitis are an area which is red, hot and is inflamed. While in hospital, patients diagnosed with lower limb Cellulitis are usually treated with antibiotics, rest and pain-killers, as well as receiving normal standard hospital care. The duration of a patient’s stay in hospital varies, but averages 5 days in hospital. Cellulitis is a skin infection and is associated with inflammation. Many infections, if caught early, respond to antibiotic therapy. However there is no specific therapy targeting the inflammatory component of Cellulitis. Systemic inflammation associated with Cellulitis generates large amounts of free-radicals and oxidative damage (stress to certain cells in your body). The ability of the body to fight such oxidative stress is dependent on your anti-oxidant system (protection of body cells from damaging effects). Vitamin C is an anti-oxidant, and it protects the body against oxidative stress. Vitamin C levels are reduced in the presence of low or high-grade systemic inflammation, such as Cellulitis.
Interventions
Intravenous Sodium Ascorbate supplied as 30g in 200mL bag which is administered at a rate of 100 mLs/hr daily for 5 days or until discharge whichever occurs first.
Sponsors
Biological Therapies
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for the study: 1. Age 18 or over. 2. Cellulitis deemed on grounds of severity to require admission for intravenous antibiotics. 3. Capable of understanding and willing to give written informed consent.
Exclusion criteria
The following will exclude patients from randomisation: 1. Dementia or mental state preventing informed consent 2. Refusal to give informed consent 3. Chronic heart failure requiring fluid restriction < 1000ml 4. Acute oliguric renal failure 5. Pulmonary oedema 6. Supplemental ingestion of Vitamin C 7. Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency 8. Any pregnant patients will be excluded (urine pregnancy test to be performed as per hospital protocol prior to randomisation. Negative result must be documented prior to randomisation).9. Patients taking any prohibited medication. 10. Diabetic patients currently on insulin.
Outcome results
None listed