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Efficacy of oral antibiotic prophylaxis in prevention of surgical site infection following skin lesion excisions at high risk of infection in general practice

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000595910
Enrollment
100
Registered
2011-06-09
Start date
2011-10-04
Completion date
2012-05-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

James Cook University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026