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NCT Number: NCT07428265

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.

Recruiting

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Medical University/Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Adnan Ali, MS

PRINCIPAL_INVESTIGATOR

Ahmed U Qureshi, FCPS

CONTACT

[email protected]

+923144001410

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Wound Healing

    Time frame: 10 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Adnan Ali, MBBS

CONTACT

[email protected]

+92 334 4323941

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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