King Edward Medical University/Mayo Hospital Lahore
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
NCT Number: NCT07428265
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.
Interested in participating?
Request Info25 year–70 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 10 weeks
Using Photographic Wound Assessment Tool, max 32, low means better healing
Contact information is provided by the study sponsor or research team.
King Edward Medical University
Other
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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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