Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

Официальное название

Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study

Обзор

This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds. Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.

Подробное описание

The study is a single center, non-inferiority, parallel group, randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds.

Patients will have follow-up with data collection at two, six and 12 weeks post-operatively. The primary outcome measure will be patient satisfaction as measured by a Likert Scale. The Likert Scale as utilized will be a patient reported outcome measure consisting of one question allowing the subject to express their attitude towards a particular subject: "How satisfied are you with your surgical treatment" with possible answers consisting of: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", and "very unsatisfied". The secondary outcome measures will be development of an infection (subcategorized as either superficial or deep) and development of peri-incisional inflammation (eg. adhesive rash).

Primary Objective: The primary objective of the study is to compare patient satisfaction as measured using a Likert Scale associated with early and delayed surgical site bathing.

Secondary Objectives: The secondary objective is to compare the infection rate of orthopaedic surgical wounds between early and delayed bathing.

Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.

Вмешательства

• Другое Time to bathing (delayed)
  Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
• Другое Time to bathing (early)
  Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Первичные конечные точки

• Patient satisfaction associated with early and delayed surgical site bathing [Срок оценки: Weeks 2, 6 and 12 post surgery]

Вторичные конечные точки (1)

• Infection rate of orthopaedic surgical wounds between early and delayed bathing [Срок оценки: Weeks 12 post surgery]

Критерии участия

Критерии включения

• Patients over 18 years of age
• Patient who are not pregnant
• Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna, femur, tibia, or fibula)
• Diagnosis of a fracture meeting indication for operative intervention
• Any fracture not requiring a splint for post-operative management
• Non-complicated wounds (non-traumatic wounds, closed injuries, fractures not requiring external fixation, and acute fracture surgery)

Критерии исключения

• Fractures associated with presumed infection
• Patients with multiple fractures
• Fractures in patients with underlying associated immune compromise
• Fractures in patients with underlying peripheral vascular disease
• Use of VAC
• Surgery performed through previous surgical wound
• Patient homeless
• Fractures in patients with underlying diabetes mellitus
• Complicated wounds (traumatic wounds, need for post-op wound care, open injuries, need for external fixation)

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

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NewYork-Presbyterian/Weill Cornell Medical Center — New York

Идентификаторы

NCT: NCT06014411 · 2023-1723 · 21-04023565

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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