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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Incision & Drainage Technique Using Cruciate Incision Followed by VAC, Saucerization Technique Followed by VAC.
- Who it may be relevant to
- Registry conditions: Carbuncle. Basic parameters: 25 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Incision & Drainage Technique Using Cruciate Incision Followed by VAC
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 - Procedure Saucerization Technique Followed by VAC
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
Primary outcome measures
- Wound Healing [Time frame: 10 weeks]
Eligibility criteria
Inclusion criteria
- All patients of either gender aged 25-70 years with ASA class 2-3 presenting to the emergency department with carbuncle requiring surgical drainage
Exclusion criteria
- Failure to tolerate VAC
- Patient with co-morbidities like: CKD, CLD, CVA
- Patients not giving consent
- Close to the anal opening
- Wound near the joint
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- King Edward Medical University/Mayo Hospital Lahore — Lahore
Identifiers
NCT: NCT07428265 · 28/REG/KEMU/25