RecruitingACTRN12623000278639

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


Sponsor

Royal Darwin Hospital

Enrollment

124 participants

Start Date

Feb 23, 2022

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

A carbuncle is a deep, painful skin infection — essentially a cluster of boils connected under the skin — that typically requires surgery to drain and clean out. The current standard surgical approach is called saucerisation, where the entire infected area is cut down to healthy tissue, often leaving a large open wound that can take weeks to heal and may require a skin graft. This trial is testing whether a less aggressive surgical approach — making a smaller cut to drain the pus and remove only the obviously infected tissue — gives equally good or better outcomes. Patients diagnosed with a carbuncle (generally in remote Northern Australia) are randomly assigned to either the current standard full-thickness excision or the more conservative incision and drainage. The study will compare how long the wound takes to heal, whether a skin graft is needed, and how long patients need to stay in hospital or make follow-up trips for care. You may be eligible if you are 18 or older and have been diagnosed with a carbuncle. People who are pregnant, breastfeeding, have significant health conditions that make surgery unsafe, or are under the Mental Health Act are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Royal Darwin Hospital - Tiwi

NT, Australia

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ACTRN12623000278639


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