Does the application of topical chloramphenicol ointment (chloromycetin) to sutured wounds reduce the incidence of wound infection following minor surgery?

ISRCTN	ISRCTN73223053
DOI	https://doi.org/10.1186/ISRCTN73223053
Secondary identifying numbers	Heal001

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Clare Heal
Scientific

10, Sunset Beach Court
Shoal Point
Mackay
4740
Australia

Study design	Randomised, controlled, double-blinded trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study objectives	Although the use of topical antibiotics after minor dermtological surger is widespread, it does not decrease the incidence of wound infection.
Ethics approval(s)	James Cook University Ethics Committee, approved on 28th March 2007 (ref: H2590)
Health condition(s) or problem(s) studied	Wound infection
Intervention	A single application of topical chloramphenicol ointment versus topical paraffin ointment following minor surgery.
Intervention type	Other
Primary outcome measure	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 study start date	10/04/2007
Completion date	10/04/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	948 (474 in each group)
Key inclusion criteria	All patients presenting to a participating GP for excision of a minor skin lesion (all body sites).
Key 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
Date of first enrolment	10/04/2007
Date of final enrolment	10/04/2008

10, Sunset Beach Court

Mackay
4740
Australia

James Cook University, School of Medicine (Australia)
University/education

-
Townsville
QLD 4811
Australia

"ROR"	https://ror.org/04gsp2c11

University/education

James Cook University, Primary Health Care Research and Development Fund (Australia)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2009		Yes	No