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Идёт набор NCT07346742

Prevention of Surgical Site Infection in Open Paediatric Groin Surgeries Using Intravenous Prophylactic Antibiotics and Antimicrobial-coated Sutures

Без фазы С лечением Inguinal Hernia Hydroceles Surgical Site Infection

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: Antimicrobial-coated sutures, Intravenous Cefuroxime, Placebo intravenous injection.
Кому может быть актуально
Состояния в реестре: Inguinal Hernia, Hydroceles, Surgical Site Infection. Базовые параметры: до 15 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
Nigeria
Следующий шаг
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Официальное название

Intravenous Prophylactic Antibiotics and Antimicrobial-Coated Sutures in Preventing Surgical Site Infection in Open Paediatric Groin Surgeries: A 3-arm Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if the use of prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The main question it aims to answer is: • Does the use of intravenous prophylactic antibiotics or antimicrobial-coated sutures significantly reduce the occurrence of surgical site infection in children undergoing open groin surgeries? Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children. Participants will: * Undergo open groin surgery with either the use of intravenous prophylactic antibiotic or antimicrobial-coated sutures or without antibiotic use * Visit the clinic on postoperative days 5, 13 and 30 for review of the surgical wounds for any sign of infection.

Подробное описание

The aim of this clinical trial is to learn if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures can prevent surgical site infection in children undergoing open groin surgeries. The specific objectives are:

* To determine the rate of surgical site infection in paediatric groin surgeries without antibiotics * To determine the rate of surgical site infection in paediatric groin surgeries with the use of intravenous prophylactic antibiotics * To determine the rate of surgical site infection in paediatric groin surgeries with the use of antimicrobial-coated sutures. * To compare the rates of surgical site infection in paediatric groin surgeries without antibiotics, with the use of intravenous prophylactic antibiotics and use of antimicrobial-coated sutures

Researchers will compare no antibiotic use to the use of intravenous prophylactic antibiotics, or antimicrobial-coated sutures to see if the use of intravenous prophylactic antibiotics and antimicrobial-coated sutures significantly reduces the occurrence of surgical site infection following open groin surgeries in children.

It shall be a double blinded randomized controlled trial

Eligible Participants will:

* On the morning of the surgery be randomly assigned to either group A or B or C * Participants in group A will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures * Participants in group B will have intravenous prophylactic antibiotic given at the induction of anaesthesia and their surgical wounds closed using non-coated sutures * Participants in group C will have intravenous placebo injection given at the induction of anaesthesia and their surgical wounds closed using antimicrobial-coated sutures * Visit the clinic on postoperative days 5, 13 and 30 for review of the surgical wounds for any sign of infection following the CDC guidelines.

Вмешательства

  • Устройство Antimicrobial-coated sutures
    Use of Antimicrobial-coated sutures to close all layers of the surgical wound following open paediatric groin surgery
  • Препарат Intravenous Cefuroxime
    Intravenous cefuroxime is given at the induction of anaesthesia
  • Другое Placebo intravenous injection
    0.2ml of Vitamin Bco injection + 9.8ml sterile water

Первичные конечные точки

  • Surgical site infection [Срок оценки: 30 days post operative period]

Критерии участия

Критерии включения

  • All patients with clinical conditions requiring daycase open groin surgery

Критерии исключения

  • Re-operations
  • Immunocompromised patients
  • Malnourished patients
  • Complicated groin pathologies e,g obstructed inguinal hernia
  • History of antibiotic usage in the last seven days

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
Четверное слепое
Основная цель
Профилактика

Центры проведения

Nigeria · 1 центр
  • Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife

Идентификаторы

NCT: NCT07346742 · ERC/2024/08/11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗