Volume Reduction for Open Fracture Irrigation

Официальное название

Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial

Обзор

The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. After the surgeon has determined a participant's bone has healed, any remaining study visits can be conducted over the phone, email, and/or mail. Participants will not be asked to attend additional clinic visits as part of this study. Researchers will compare two different fluid volume protocols to determine if one results in better fracture and/or wound healing.

Подробное описание

This study compares the two irrigation protocols for Irrigation and Debridement (I\&D) of open fractures. Open fractures are classified using the Gustilo-Anderson classification criteria, which divides these fractures into Types I, II, and III. The study protocols being compared differ in the volume of normal sterile saline used during the I\&D procedure. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III. Irrigation volumes for Protocol A are based on current practice by orthopedic trauma surgeons at Inova. Volumes in Protocol B are based on the FLOW trial study design.

Hypothesis: Decreased irrigation volumes (Protocol A) during surgical I\&D will be non-inferior to high irrigation volumes (Protocol B) with respect to the development of surgical site infection.

Study Design: This is a bimonthly cluster randomized trial in which the study. When enrollment begins, the first two-month (60-day) period will be randomly assigned to either Protocol A or B. Thereafter, the study treatment in effect allocation will alternate every two months (60 days). Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.

This study design is based on the PREP-IT and PREPARE trials, which were national, multicenter RCTs that compared post-surgical infection rates after using different skin sterilization solutions to prepare surgical sites of open and closed fractures.

Patients will receive the protocol in effect at the time they consent to participate in the study, prior to their I\&D, unless otherwise clinically indicated by their study surgeon while in the operating room (OR). All open fracture patients will be screened for participation in the study during their initial evaluation and admission to the hospital, based on inclusion and exclusion criteria detailed in the study protocol. A member of the study team will discuss the study with patients meeting the appropriate criteria prior to their first I\&D. These patients will either be consented/enrolled or will be screen failed due to lack of consent.

Вмешательства

• Препарат 0.9% Sodium Chloride
  Sterile 0.9% sodium chloride irrigation administered intraoperatively for the purposes of irrigating open fracture wounds. The volume of sterile 0.9% sodium chloride solution used during irrigation is determine by the arm participants are randomized to and the open fracture classification as determined by the study surgeon in the operating room.

Первичные конечные точки

• Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures. [Срок оценки: 90 days after first irrigation and debridement conducted in the operating room]

Критерии участия

Критерии включения

• Age 18 or older
• Patient diagnosed with a Type I, II, or III open fracture of the appendicular skeleton by a study surgeon
• For the purposes of this study, an open fracture is a fracture associated with a soft tissue wound which may or may not be contiguous with the fracture.
• Open fractures of the carpals, tarsals, metacarpals, metatarsal, and/or phalanges without the involvement of a long bone or the hindfoot will not be considered.

Критерии исключения

• Patient is unable to understand Informed Consent and/or HIPAA Authorization Form
• Patient does not speak English
• Patient is pregnant
• Patient is unable or (in the judgment of research personnel) unlikely to attend follow-up visits.
• Patient was previously enrolled in a study which has the same primary outcomes or may influence infection rate or bone healing
• Patient declines to participate in study

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

США · 1 центр

• Inova Health System — Falls Church

Публикации

• Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry DJ, Harrast J, Derosa GP. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: Part-II, certification examination case mix. J Bone Joint Surg Am. 2006 Mar;88(3):660-7. doi: 10.2106/JBJS.E.01208. No abstract available. PMID 16510834
• Anglen JO. Wound irrigation in musculoskeletal injury. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26. doi: 10.5435/00124635-200107000-00001. PMID 11476531
• Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014 May;42(5):525-9. doi: 10.1016/j.ajic.2014.01.012. PMID 24773788
• Crowley DJ, Kanakaris NK, Giannoudis PV. Irrigation of the wounds in open fractures. J Bone Joint Surg Br. 2007 May;89(5):580-5. doi: 10.1302/0301-620X.89B5.19286. PMID 17540739
• Howard M, Court-Brown CM. Epidemiology and management of open fractures of the lower limb. Br J Hosp Med. 1997 Jun 4-17;57(11):582-7. PMID 9307681
• Peterson L.W. Prophylaxis of wound infection: studies with particular reference to soaps and irrigation. Arch Surg. 1945;50(4):177-183
• Zalavras CG, Marcus RE, Levin LS, Patzakis MJ. Management of open fractures and subsequent complications. J Bone Joint Surg Am. 2007 Apr;89(4):884-95. doi: 10.2106/00004623-200704000-00027. No abstract available. PMID 17432452
• Cross WW 3rd, Swiontkowski MF. Treatment principles in the management of open fractures. Indian J Orthop. 2008 Oct;42(4):377-86. doi: 10.4103/0019-5413.43373. PMID 19753224

Идентификаторы

NCT: NCT07437339 · INOVA-2025-149

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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