MedTrace Logo

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.

NCT07428265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-02-23

No results posted yet for this study

Summary

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.

Conditions

  • Carbuncle

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 patient's postoperative hospital stay may be prolonged until the sepsis is adequately controlled with antibiotics.

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 in a large wound that heals by secondary intention, often requiring subsequent skin grafting or flap coverage and leading to a larger scar.

Sponsors & Collaborators

  • King Edward Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-02
Primary Completion
2026-02-28
Completion
2026-03-01

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07428265 on ClinicalTrials.gov