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A randomised controlled trial comparing materials needed for skin punch and shave biopsies

A randomised controlled trial comparing infection rates in adult patients undergoing 2-4mm skin punch and shave biopsies with or without a sterile dressing pack

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000530426
Enrollment
84
Registered
2025-05-26
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This study aims to compare two ways of performing skin biopsies, using a full sterile dressing pack versus a simplified method without it, to determine whether the simpler approach is just as safe and effective. Skin punch and shave biopsies are minor procedures used to diagnose skin conditions, including skin cancer. The current standard uses a sterile pack, which generates more waste and cost. However, clinician experience suggests that for small 2mm biopsies, using fewer materials may still lead to excellent patient outcomes. This research will test whether avoiding the sterile pack increases the risk of infection. The study’s hypothesis is that performing 2-4 mm skin biopsies without a sterile dressing pack is just as safe as doing them with full sterile materials. If proven, this could reduce healthcare waste, lower costs, and support environmentally sustainable practices, without compromising patient care.

Interventions

Participants undergoing a 2-4 mm skin punch or shave biopsy at Drummoyne Dermatology (a dermatology outpatient clinic) will be randomised into two groups: Intervention group: Biopsy performed using 2-4 mm punch or shave biopsy tool, 5% chlorhexidine solution, hyfrecator and suture material (if required) without the use of a dressing pack. Control group: Biopsy performed as per routine clinical practice using 2mm punch or shave biopsy tool, 5% chlorhexidine solution, hyfrecator and suture mate

Participants undergoing a 2-4 mm skin punch or shave biopsy at Drummoyne Dermatology (a dermatology outpatient clinic) will be randomised into two groups: Intervention group: Biopsy performed using 2-4 mm punch or shave biopsy tool, 5% chlorhexidine solution, hyfrecator and suture material (if required) without the use of a dressing pack. Control group: Biopsy performed as per routine clinical practice using 2mm punch or shave biopsy tool, 5% chlorhexidine solution, hyfrecator and suture material (if required) with a dressing pack. Dressing pack contains: Sterile field PE material 50 x 49cm, dressing tray, 4 plain gauze swabs 7.5x7.5cm, blue sterile field 60x60cm, 3 aqua forceps 107mm, paper dressing towel 2 ply. The intervention being tested is the omission of a dressing pack and use of reduced materials during minor skin biopsy procedures. The biopsy will be performed by doctors working at the clinic. The strategy used to monitor adherence to the intervention is direct observation by research investigator.

Sponsors

Dr Rebecca Saunderson - Drummoyne Dermatology
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Adults 18 years or older who can provide informed medical consent Patients needing a 2 to 4 mm skin punch or shave biopsy as determined by treating clinician

Exclusion criteria

Patients under 18 years old Patients from a non-English speaking background without a command of English Patients who do not have the capacity to consent Patients who do not require 2 to 4 mm punch or shave biopsy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026