Comparison of Wound Healing for Diabetic Carbuncle Treated With Incision and Drainage Technique Using Cruciate Incision vs Saucerization Technique Both Followed by Vacuum Assisted Closure.

ConditionCarbuncle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorKing Edward Medical University

About this trial

The goal of this clinical trial is to compare the effectiveness of two surgical techniques for wound healing in diabetic patients aged 25-70 years with a carbuncle requiring surgical drainage. The main questions it aims to answer are:

Is there a difference in blood loss during surgery between the two techniques?

Is there a difference in the duration required for wound healing between the two techniques?

Researchers will compare the Incision \& Drainage group to the Saucerization group (both followed by Vacuum Assisted Closure) to see which technique results in better outcomes.

Participants will:

Be randomly assigned to one of the two surgical groups.

Receive their assigned surgical procedure (either cruciate incision \& drainage or saucerization).

Receive post-operative Vacuum Assisted Closure (VAC) therapy.

Have their wounds assessed during follow-up visits every 14 days until healed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients of either gender aged 25-70 years with ASA class 2-3 presenting to the emergency department with carbuncle requiring surgical drainage

Disqualifiers

Failure to tolerate VAC

Patient with co-morbidities like: CKD, CLD, CVA

Patients not giving consent

Close to the anal opening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Incision & Drainage Technique Using Cruciate Incision Followed by VAC

    Procedure/Surgery

    This is a less radical procedure focused on establishing a drainage pathway for the underlying pus collection. It involves making a cruciate (cross-shaped) incision over the carbuncle. Unlike saucerization, it does not involve wide excision of tissue. Postoperatively, broad-spectrum antibiotics are administered to control the remaining cellulitis and infection. This technique is associated with less blood and tissue loss, a smaller final scar, and potentially faster initial healing. However, the patient's postoperative hospital stay may be prolonged until the sepsis is adequately controlled with antibiotics.

  • Saucerization Technique Followed by VAC

    Procedure/Surgery

    This is a radical surgical procedure for a diabetic carbuncle. It involves the complete excision of all dead (necrotic) tissue at the center of the infection, along with the surrounding area of cellulitis. The goal is to achieve healthy, bleeding margins and remove the entire septic focus. While this extensive removal may eliminate the need for postoperative antibiotics, it is associated with significant intraoperative blood loss, which can necessitate a blood transfusion. The procedure results in a large wound that heals by secondary intention, often requiring subsequent skin grafting or flap coverage and leading to a larger scar.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Incision & Drainage Technique Using Cruciate Incision Followed by VACActive comparator 1 intervention
Group B: Saucerization Technique Followed by VACActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Wound Healing

Using Photographic Wound Assessment Tool, max 32, low means better healing

Time frame
10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.