Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000595910
Ethics application status
Approved
Date submitted
1/06/2011
Date registered
9/06/2011
Date last updated
1/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of oral antibiotic prophylaxis in prevention of surgical site infection following skin lesion excisions at high risk of infection in general practice
Scientific title
A primary care study of skin lesions excisions from the lower limb and groin and excisions from any site in diabetics comparing the effect of a 2g oral dose of cephalexin administered 30-60 minutes prior to the operation and a placebo in the prevention of subsequent surgical site infection
Secondary ID [1] 262298 0
Nil
Universal Trial Number (UTN)
U1111-1121-7889
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infections following skin lesion excisions from the lower limb or groin in general practice 267955 0
Surgical site infections following skin lesion excisions from any site in diabetics in general practice 267956 0
Condition category
Condition code
Infection 268094 268094 0 0
Studies of infection and infectious agents
Surgery 268134 268134 0 0
Other surgery
Metabolic and Endocrine 268135 268135 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 g oral dose cephalexin (administered in 4 x 500mg capsules) 30-60 minutes prior to skin lesion excisions from the lower limb or groin or any site from diabetics
Intervention code [1] 266652 0
Prevention
Comparator / control treatment
Inert gel capsule, identical to that containing cephalexin.
Control group
Placebo

Outcomes
Primary outcome [1] 266838 0
Presence or absence of wound infection defined as:
Purulent discharge from the wound must be present
OR
Atleast one of the following signs and symptoms of infection
Pain/Tenderness
Localised swelling
Heat
Erythema >1cm
Timepoint [1] 266838 0
When patients return for suture removal (10 days for excisions from back and shin, 7 days for all other sites) or earlier if patients re-present due to perceived infection (date which wound is assessed at will be recorded)
Secondary outcome [1] 276490 0
Wound grade
1. No infection or erythema
2. Stitch abscess
3. Less than 1cm of erythema with no pain, heat or swelling
4. Less than 1 cm erythema from the wound margin with pain, heat or swelling
5. Greater than 1 cm erythema from the wound margin with no pain, heat or swelling
6. Greater than 1 cm erythema from the wound margin with pain, heat or swelling
7.Deep infection or systemic symptoms (including lymphangitis, regional lymphadenopathy)
Timepoint [1] 276490 0
When patients return for suture removal (10 days for excisions from back and shin, 7 days for all other sites) or earlier if patients re-present due to perceived infection (date which wound is assessed at will be recorded)
Secondary outcome [2] 276492 0
Prescription of antibiotics for wound infection
Timepoint [2] 276492 0
When patients return for suture removal (10 days for excisions from back and shin, 7 days for all other sites) or earlier if patients re-present due to perceived infection (date which wound is assessed at will be recorded)
Secondary outcome [3] 276493 0
Additional consultations required for wound to be reviewed or re-dressed due to infection
Timepoint [3] 276493 0
Recorded each time patients re-presents primarily in order to have wound reviewed or re-dressed due to diagnosed infection at time or suture removal or earlier for up to 30 days after skin lesion excision

Eligibility
Key inclusion criteria
1. >18 yrs old
2. Capable of informed consent
3. Presenting for excision of a minor skin lesion from lower leg or groin OR Diabetic presenting for skin lesion excision from any site
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently taking antibiotics or clinically indicated for antibiotic treatment following excision
Repair of lacerations or lesion considered contaminated/infected prior to surgery
Excision not requiring sutures (E.g. shave biopsy or curette)
Excision of sebaceous cyst
Patient unable to return for suture removal
Penicillin or cephalosporin allergy

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)
Consecutive patients presenting at participating general practices are eligible for the trial provided the meet inclusion/exclusion criteria
Practices doctors and nurses responsible for recruiting patients to the trial
If interested in participating, patient will be asked to give signed consent before being allocated a consecutive number by the enrolling nurse or doctor
This number will correspond to a numbered container containing the capsules the patient will receive upon returning to have their skin lesion/s excised. The contents of the capsules held within each numbered container will be determined using a computer generated random sequence and will be blinded to all parties directly involved in allocation, administration of capsules and outcome assessment. In the event that an adverse event occurs the trial coordinators will inform the treating doctor of the contents of the capsule and the participant will be removed from the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A sequence of consecutive numbers randomised to either intervention or control will be generated using a computer randomisation. This sequence will be used to create numbered containers which will containing identical capsules filled with either the intervention or control substance depending on the group to which the number was allocated during computer randomisation. Each enrolled patient will be assigned a consecutive number and will receive the capsules from the corresponding numbered container upon return for skin lesion excision.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
4/10/2011
Date of last participant enrolment
Anticipated
Actual
31/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 267145 0
University
Name [1] 267145 0
James Cook University
Country [1] 267145 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
School of Medicine and dentistry
Mackay Base Hospital
Bridge Rd
Mackay QLD 4740
Country
Australia
Secondary sponsor category [1] 266217 0
None
Name [1] 266217 0
Address [1] 266217 0
Country [1] 266217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269134 0
James Cook University Human Ethics Committee
Ethics committee address [1] 269134 0
Human Ethics and Grants Administrator
Research Office
Room 021 A
Ground Floor
Kevin Stark Research Building (DB019)
James Cook University
Townsville, Qld 4811
Ethics committee country [1] 269134 0
Australia
Date submitted for ethics approval [1] 269134 0
Approval date [1] 269134 0
05/05/2011
Ethics approval number [1] 269134 0
H4113

Summary
Brief summary
Certain risk factors are known to be associated with a predictably high rate of surgical wound infection following minor dermatological procedures such as skin lesion excision. The use of oral antibiotic prophylaxis has been suggested as one way of reducing this risk of infection. This project seeks to test the efficacy of such recommendations in the form of a double blind randomised control trial. For the purposes of this trial the high risk group was defined as patients undergoing skin lesion excisions from the lower limb and groin and diabetics having skin lesion excisions from any site. The intervention will consist of a 2g oral dose of cephalexin administered 30-60 minutes prior to the excision while the control will be an identical placebo. Wounds will be assessed for infection using a standardised criteria when patients return for suture removal or earlier if participants re-present due to perceived infection. A wound grading system will also be used and other information which may correlate with infection will also be recorded. This project aims to enrol 100 patients and is a pilot for a large scale multi-centre trial currently in planning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32660 0
Dr Samuel Smith
Address 32660 0
Unit 29
159 Riverside Boulevard
Douglas, QLD 4814
Country 32660 0
Australia
Phone 32660 0
+61407256136
Fax 32660 0
Email 32660 0
[email protected]
Contact person for public queries
Name 15907 0
Samuel Smith
Address 15907 0
James Cook University
Unit 29
159 Riverside Boulevard
Douglas, QLD 4814
Country 15907 0
Australia
Phone 15907 0
+61 (0)407256136
Fax 15907 0
+61 7 4885 7111
Email 15907 0
[email protected]
Contact person for scientific queries
Name 6835 0
Samuel Smith
Address 6835 0
Student Accommodation
School of Medicine and dentistry
Mackay Base Hospital
Bridge Rd
Mackay, QLD 4740
Country 6835 0
Australia
Phone 6835 0
+61 (0)407256136
Fax 6835 0
+61 7 4885 7111
Email 6835 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
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