CarbuncleNCT07428265
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.
A study testing Incision & Drainage Technique Using Cruciate Incision Followed by VAC and Saucerization Technique Followed by VAC in people with Carbuncle, run by King Edward Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Carbuncle
- What is being tested?
- Incision & Drainage Technique Using Cruciate Incision Followed by VAC and Saucerization Technique Followed by VAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2026to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of either gender aged 25-70 years with ASA class 2-3 presenting to the emergency department with carbuncle requiring surgical drainage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University/Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Ahmed U Qureshi, FCPS, +923144001410, ahmeduzairq@gmail.com
Adnan Ali, MS
About this study
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?
Read more
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
- Being tested
- Incision & Drainage Technique Using Cruciate Incision Followed by VAC, Saucerization Technique Followed by VAC
- Medical subject headings
- Carbuncle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incision & Drainage Technique Using Cruciate Incision Followed by VACProcedure or surgery
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 VACProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Incision & Drainage Technique Using Cruciate Incision Followed by VAC | Active comparator | Not described Receives: Procedure: Incision & Drainage Technique Using Cruciate Incision Followed by VAC |
| Saucerization Technique Followed by VAC | Active comparator | Not described Receives: Procedure: Saucerization Technique Followed by VAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Using Photographic Wound Assessment Tool, max 32, low means better healing
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start2 Jan 2026
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarbuncleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428265
- Sponsor's protocol ID
- 28/REG/KEMU/25
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07428265
- Acronym / sponsor ID
- 28/REG/KEMU/25
- Conditions
- Carbuncle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of either gender aged 25-70 years with ASA class 2-3 presenting to the emergency department with carbuncle requiring surgical drainage
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incision & Drainage Technique Using Cruciate Incision Followed by VACThis 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 or surgery | Incision & Drainage Technique Using Cruciate Incision Followed by VAC |
| Saucerization Technique Followed by VACThis 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. | Procedure or surgery | Saucerization Technique Followed by VAC |
Primary outcome
Wound Healing
Time frame: 10 weeks
Using Photographic Wound Assessment Tool, max 32, low means better healing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incision & Drainage Technique Using Cruciate Incision Followed by VAC and Saucerization Technique Followed by VAC in people with Carbuncle, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adnan Ali, MBBS (+92 334 4323941, heartheart5000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.