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.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Incision & Drainage Technique Using Cruciate Incision Followed by VAC, Saucerization Technique Followed by VAC.
- Кому может быть актуально
- Состояния в реестре: Carbuncle. Базовые параметры: 25 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Пакистан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Вмешательства
- Процедура Incision & Drainage Technique Using Cruciate Incision Followed by VAC
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 - Процедура Saucerization Technique Followed by VAC
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
Первичные конечные точки
- Wound Healing [Срок оценки: 10 weeks]
Критерии участия
Критерии включения
- All patients of either gender aged 25-70 years with ASA class 2-3 presenting to the emergency department with carbuncle requiring surgical drainage
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Пакистан · 1 центр
- King Edward Medical University/Mayo Hospital Lahore — Lahore
Идентификаторы
NCT: NCT07428265 · 28/REG/KEMU/25