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How Deep? - A randomised controlled trial into the surgical treatment of carbuncles

How deep - A randomised controlled trial comparing incision and drainage and conservative debridement versus conventional full thickness excision (saucerisation) for the surgical treatment of carbuncles in adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000278639
Enrollment
10
Registered
2023-03-15
Start date
2022-02-23
Completion date
2023-12-01
Last updated
2023-03-20

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

Conditions

None listed

Brief summary

A randomised control trial investigating the surgical management of carbuncles, with the goal to identify whether incision and drainage with conservative debridement of carbuncles is superior to the current standard of full-thickness excision (saucerisation). The hypotheses tested involves comparing the two surgeries in their wound healing time, likeliness to require skin graft, and overall length of hospital stay and patient travel episodes.

Interventions

Arm2: Incision and Drainage and Conservative Debridement Why: Removal of carbuncle while maintaining deeper dermis What: Defined as incision and drainage of pus, removal of tissue but maintaining underling deeper dermis. Who: Surgeon trained in method of carbuncle removal How: Face-to-face (surgery) Surgical procedure is roughly 20 minutes Post surgery, patient surgical record is checked to confirm that it was: a) a carbuncle. b) the correct surgical method. Where: Royal Darwin Hospital operat

Arm2: Incision and Drainage and Conservative Debridement Why: Removal of carbuncle while maintaining deeper dermis What: Defined as incision and drainage of pus, removal of tissue but maintaining underling deeper dermis. Who: Surgeon trained in method of carbuncle removal How: Face-to-face (surgery) Surgical procedure is roughly 20 minutes Post surgery, patient surgical record is checked to confirm that it was: a) a carbuncle. b) the correct surgical method. Where: Royal Darwin Hospital operating theatre When: One session once admitted to Royal Darwin Hospital and randomised to arm of trial Weekly wound reviews (photo and measuring) for 12 weeks to monitor wound healing.

Sponsors

Royal Darwin Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Once a diagnosis of carbuncle is confirmed, all patients except those who meet the exclusion criteria, will be informed of the standard surgical management, and offered the opportunity the participate in this Randomised Controlled Trial.

Exclusion criteria

Patients under 18 years of age. Patients who are pregnant. Patients who are breastfeeding. Non-operative candidates due to anaesthetic risk and significant comorbidities. Patients under Guardianship. Patients under the Mental Health Act. Patients not wishing to participate.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026