Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Heal001
Study information
Scientific title
Acronym
Study hypothesis
Although the use of topical antibiotics after minor dermtological surger is widespread, it does not decrease the incidence of wound infection.
Ethics approval
James Cook University Ethics Committee, approved on 28th March 2007 (ref: H2590)
Study design
Randomised, controlled, double-blinded trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Wound infection
Intervention
A single application of topical chloramphenicol ointment versus topical paraffin ointment following minor surgery.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Infection. The wounds will be assessed for infection at time of removal of sutures (5-14 days).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
10/04/2007
Overall trial end date
10/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
All patients presenting to a participating GP for excision of a minor skin lesion (all body sites).
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
948 (474 in each group)
Participant exclusion criteria
1. Already taking oral antibiotics
2. Oral or topical antibiotics clinically indicated immediately postoperatively
3. Lacerations
4. Having a flap or two layer procedure
5. Having excision of sebaceous cyst
6. History of allergy to any of ingredients of chloromycetin ointment
7. Personal or family history of aplastic anaemia
Recruitment start date
10/04/2007
Recruitment end date
10/04/2008
Locations
Countries of recruitment
Australia
Trial participating centre
10, Sunset Beach Court
Mackay
4740
Australia
Funders
Funder type
University/education
Funder name
James Cook University, Primary Health Care Research and Development Fund (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19147639
Publication citations
-
Results
Heal CF, Buettner PG, Cruickshank R, Graham D, Browning S, Pendergast J, Drobetz H, Gluer R, Lisec C, Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial., BMJ, 2009, 338, a2812.