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 | Recruiting DMC

• 1 other identifier: 28/REG/KEMU/25
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Wound Healing

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

  10 weeks

Study Arms (2)

Incision & Drainage Technique Using Cruciate Incision Followed by VAC

ACTIVE COMPARATOR

Procedure: Incision & Drainage Technique Using Cruciate Incision Followed by VAC

Saucerization Technique Followed by VAC

ACTIVE COMPARATOR

Procedure: Saucerization Technique Followed by VAC

Interventions

Incision & Drainage Technique Using Cruciate Incision Followed by VAC PROCEDURE

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.

Incision & Drainage Technique Using Cruciate Incision Followed by VAC

Saucerization Technique Followed by VAC PROCEDURE

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.

Saucerization Technique Followed by VAC

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University/Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Carbuncle

Condition Hierarchy (Ancestors)

Furunculosis; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Adnan Ali, MBBS

CONTACT

+92 334 4323941; heartheart5000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: February 23, 2026
• Study Start: January 2, 2026
• Primary Completion: February 28, 2026
• Study Completion: March 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)