Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incision & Drainage Technique Using Cruciate Incision Followed by VAC | Active Comparator |
| |
| Saucerization Technique Followed by VAC | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | Using Photographic Wound Assessment Tool, max 32, low means better healing | 10 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adnan Ali, MBBS | Contact | +92 334 4323941 | heartheart5000@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Edward Medical University/Mayo Hospital Lahore | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Jan 3, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form | Oct 9, 2025 | Jan 2, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002270 | Carbuncle |
| ID | Term |
|---|---|
| D005667 | Furunculosis |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided