RecruitingNot ApplicableNCT07428265

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.


Sponsor

King Edward Medical University

Enrollment

124 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 70 Years

Inclusion Criteria1

  • 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 Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREIncision & 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.

PROCEDURESaucerization 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.


Locations(1)

King Edward Medical University/Mayo Hospital Lahore

Lahore, Punjab Province, Pakistan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07428265


Related Trials