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Trial registered on ANZCTR


Registration number
ACTRN12610000762055
Ethics application status
Approved
Date submitted
2/09/2010
Date registered
14/09/2010
Date last updated
12/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single Site, Randomized, Single-Blind, Parallel-group, Placebo-Controlled Study to investigate reduction of inflammation using Intravenous Sodium Ascorbate in patients with Cellulitis
Scientific title
A Single Site, Randomized, Single-Blind, Parallel-group, Placebo-Controlled Study to investigate reduction of inflammation using Intravenous Sodium Ascorbate in patients with Cellulitis
Secondary ID [1] 252512 0
None
Universal Trial Number (UTN)
U1111-1116-6339
Trial acronym
Cellulitis Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulitis 258006 0
Condition category
Condition code
Skin 258175 258175 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257052 0
Treatment: Drugs
Comparator / control treatment
Intravenous matching placebo supplied as 200mL bag half-normal saline which is administered at a rate of 100 mLs/hr daily for 5 days or until discharge whichever occurs first.
Control group
Placebo

Outcomes
Primary outcome [1] 259036 0
The primary objective is to determine if adding high-dose intravenous antioxidant therapy (sodium ascorbate) to standard therapy will reduce a patient?s inflammatory conditions using max C-reactive protein (CRP) as the surrogate marker. A blood sample will taken at baseline and then daily to obtain the Max CRP value.
Timepoint [1] 259036 0
5 days' following admission to the hospital.
Primary outcome [2] 259037 0
The primary objective is to determine if adding high-dose intravenous antioxidant therapy (sodium ascorbate) to standard therapy will improve the Cellulitis Visual Score.
Timepoint [2] 259037 0
5 days' following admission to the hospital.
Secondary outcome [1] 265283 0
The secondary objective is to determine if adding high-dose intravenous antioxidant therapy (sodium ascorbate) to standard therapy will reduce a patient's length of stay in hospital. This will be determined from the patient's hospital notes which document the time and date of admission to the hospital until the date and time of discharge.
Timepoint [1] 265283 0
5 days' following admission to the hospital
Secondary outcome [2] 265284 0
The secondary objective is to determine if adding high-dose intravenous antioxidant therapy (sodium ascorbate) to standard therapy is safe and tolerable. This will be assessed using the results from daily Full Blood Count data and reporting of adverse events. Expected events are: Skin ulceration, Serous exudate, Abscess formation, steomyelitis & Discomfort in the vein during infusion. Daily trial nurse assessment and review of the patient's medical record will be used to assess all adverse events.
Timepoint [2] 265284 0
5 days' following admission to the hospital

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The site staff who have been trained on the protocol will contact the Coordinating Centre (GLCC) via telephone when they are ready to perform a randomisation. The required details will be given over the phone and repeated to confirm they are correct. Then the randomisation will be performed by a trained GLCC emplyee using an Oracle database module specifically designed and tested for randomisations. The allocation of study kits to patients will be based on a random list supplied to the GLCC programmer by the independent statistician for use in the randomisation module. When a randomisation has been performed the site staff will receive an email confirming the details so that they can obtain the correct kit number for the patient. Only the statistician and GLCC programmer will be aware of the randomisation schedule in New Zealand.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Then the randomisation will be performed by a trained GLCC emplyee using an Oracle database module specifically designed and tested for randomisations. The allocation of study kits to patients will be based on a random list supplied to the GLCC programmer by the independent statistician for use in the randomisation module.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Single site
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2010
Actual
18/08/2011
Date of last participant enrolment
Anticipated
3/07/2013
Actual
3/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 2822 0
New Zealand
State/province [1] 2822 0
Whangarei

Funding & Sponsors
Funding source category [1] 257500 0
Hospital
Name [1] 257500 0
Whangarei Hospital, General Medical Trust
Country [1] 257500 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Biological Therapies
Address
Division of Orthomolecular Medisearch Laboratories Pty Ltd.
5/20-30 Malcolm Rd
Braeside VIC 3195
Country
Australia
Secondary sponsor category [1] 256732 0
None
Name [1] 256732 0
Address [1] 256732 0
Country [1] 256732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259525 0
Northern X Ethics Committee
Ethics committee address [1] 259525 0
3rd floor, Unisys building
650 Great South Rd
Penrose 1061
Auckland
Ethics committee country [1] 259525 0
New Zealand
Date submitted for ethics approval [1] 259525 0
27/08/2010
Approval date [1] 259525 0
16/11/2010
Ethics approval number [1] 259525 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
The protocol stated a sample size of 140 was required for a clear result. Our initial assessment based on previous admission rates indicated the site should be able to achieve this within 2 years. Unfortunately, an unforeseen change in the way treatment for cellulitis was delivered, with the sudden move away from hospital admission for treatment meant that after recruitment started the trial the numbers admitted fell dramatically. As a consequence, after 2 years the site only managed to recruit 16 patients. The PI decided to terminate the trial prematurely as a consequence.

The results obtained from the 16 patients suggested a possible positive impact of the treatment, but unfortunately the numbers were too few to make a clear judgement on whether using this as a treatment is worthwhile.

Contacts
Principal investigator
Name 31544 0
Mr Nigel Harrison
Address 31544 0
CCU Department Whangarei Hospital Maunu Road WHANGAREI, 0110
Country 31544 0
New Zealand
Phone 31544 0
+64 9 430 4100 ext 7662
Fax 31544 0
+64 9 430 4117
Email 31544 0
nigel.harrison@northlanddhb.org.nz
Contact person for public queries
Name 14791 0
Wendy Coleman
Address 14791 0
CCU Department
Whangarei Hospital
Maunu Road
WHANGAREI, 0110
Country 14791 0
New Zealand
Phone 14791 0
+64 9 430 4100 ext 7662
Fax 14791 0
+64 9 430 4117
Email 14791 0
wendy.coleman@northlanddhb.org.nz
Contact person for scientific queries
Name 5719 0
Wendy Coleman
Address 5719 0
CCU Department
Whangarei Hospital
Maunu Road
WHANGAREI, 0110
Country 5719 0
New Zealand
Phone 5719 0
+64 9 430 4100
Fax 5719 0
+64 9 430 4117
Email 5719 0
wendy.coleman@northlanddhb.org.nz

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Results publications and other study-related documents

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