Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000031268
Ethics application status
Approved
Date submitted
26/11/2008
Date registered
16/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of benzyl-nicotinate on wound infection in surgical patients
Scientific title
The effect of topical benzyl-nicotinate application on surgical site infection in patients undergoing general surgical operations with a skin incision.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection 4019 0
Condition category
Condition code
Surgery 4224 4224 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A topical cream containing benzyl nicotinate will be applied on the site of planned surgical incision. This molecule has a distinct vasodilative effect peaking at the 10th minute of application which lasts about 45 minutes. The cream which contains benzyl nicotinate also contains etofenamate; an antiinflammatory agent. The cream is placed in a syringe with the needle removed. The cream is applied to the incision with a dose of 1 mg benzyl nicotinate applied to each cm of the wound (1 ml cream/10 cm). The cream is applied on the operating table on the planned incision. The necessary amount will be distibuted homogenously on the planned incision with a width of 1 cm. Then the skin is prepared and draped. The surgery goes on as usual. The observation period is 30 postoperative days.
Intervention code [1] 3744 0
Prevention
Comparator / control treatment
A gel containing only etofenamate as the active agent will be used as the control. In order to apply the same dose of etofenamate as applied in the study group (10 mg to each cm) 2 ml of the control gel will be applied to each 10 cm of the planned wound. The operation goes on as usual as described in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 5115 0
Surgical site infection. This will be assessed by monitorization of the health care professionals. If the wound is opened microbiological culture assessment will be done additionally.
Timepoint [1] 5115 0
Within 30 days of the operation.
Secondary outcome [1] 8612 0
All cause mortality. This will be assessed by health care professionals if the patient is still hospitalized. If the patient is discharged within the time frame of the study the patient will be invited for clinical examination. If this is not possible the patient will be contacted by telephone.
Timepoint [1] 8612 0
Within 30 days of the operation.

Eligibility
Key inclusion criteria
All general surgical patients needing a skin incision.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients who refuse to participate, operations involving perianal region, burn patients, patients undergoing a secondary operation within 30 days unless the reason is the surgical site infection.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1260
Accrual to date
Final
Recruitment outside Australia
Country [1] 1409 0
Turkey
State/province [1] 1409 0

Funding & Sponsors
Funding source category [1] 4205 0
University
Name [1] 4205 0
Baskent University
Country [1] 4205 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
1. Cadde 16. Sokak No:11 06490 Bahcelievler / ANKARA
Country
Turkey
Secondary sponsor category [1] 3777 0
None
Name [1] 3777 0
Address [1] 3777 0
Country [1] 3777 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Wound infection following general surgical operations is a serious problem. As the number of the surgical procedures performed is large, any intervention having the potential to decrease this morbidity even by a small fraction will be beneficial. The most important barrier to infection is a healthy, well vascularized wound. A cream containing benzyl-nicotinate dilates the capillaries and small vessels and increases the blood flow in the skin and subcutaneous tissues when applied to the skin. In this study, the effect of this vessel dilating cream will be assessed on wound infection in patients undergoing general surgical operations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29162 0
Address 29162 0
Country 29162 0
Phone 29162 0
Fax 29162 0
Email 29162 0
Contact person for public queries
Name 12319 0
Tarik Zafer Nursal
Address 12319 0
Gürselpasa Mah. Mavi Bulvar No:133/2 Senbayrak Sitesi B-Blok Seyhan / Adana
Country 12319 0
Turkey
Phone 12319 0
+905327763645
Fax 12319 0
Email 12319 0
[email protected]
Contact person for scientific queries
Name 3247 0
Tarik Zafer Nursal
Address 3247 0
Gürselpasa Mah. Mavi Bulvar No:133/2 Senbayrak Sitesi B-Blok Seyhan / Adana
Country 3247 0
Turkey
Phone 3247 0
+905327763645
Fax 3247 0
Email 3247 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.