Condition category
Infections and Infestations
Date applied
02/04/2007
Date assigned
02/07/2007
Last edited
19/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clare Heal

ORCID ID

Contact details

10
Sunset Beach Court
Shoal Point
Mackay
4740
Australia

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

Sponsor information

Organisation

James Cook University, School of Medicine (Australia)

Sponsor details

-
Townsville
QLD 4811
Australia

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes