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.

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.

Study Overview

• Status: Recruiting
• Conditions: Carbuncle
• Intervention / Treatment: Procedure: Incision & Drainage Technique Using Cruciate Incision Followed by VAC; Procedure: Saucerization Technique Followed by VAC

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adnan Ali, MBBS; Phone Number: +92 334 4323941; Email: heartheart5000@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Recruiting
      • king Edward medical university/mayo hospital lahore
      • Contact: Ahmed U Qureshi, FCPS; Phone Number: +923144001410; Email: ahmeduzairq@gmail.com
      • Principal Investigator: Adnan Ali, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Incision & Drainage Technique Using Cruciate Incision Followed by VAC	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.
Active Comparator: Saucerization Technique Followed by VAC	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing	Using Photographic Wound Assessment Tool, max 32, low means better healing	10 weeks

Collaborators and Investigators

• Sponsor: King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2026
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Bacterial; Skin Diseases, Infectious; Staphylococcal Skin Infections; Staphylococcal Infections; Skin and Connective Tissue Diseases; Furunculosis; Carbuncle
• Other Study ID Numbers: 28/REG/KEMU/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No