Abstract:
BACKGROUND:Open fractures frequently result in serious complications for patients, including infections, wound healing problems, and failure of fracture healing, many of which necessitate subsequent operations. One of the most important steps in the initial management of open fractures is a thorough wound irrigation and debridement to remove any contaminants. There is, however, currently no consensus regarding the optimal approach to irrigating open fracture wounds during the initial operative procedure. The selection of both the type of irrigating fluid and the pressure of fluid delivery remain controversial. The primary objective of this study is to investigate the effects of irrigation solutions (soap vs. normal saline) and pressure (low vs. high; gravity flow vs. high; low vs. gravity flow) on re-operation within one year among patients with open fractures. METHODS/DESIGN:The FLOW study is a multi-center, randomized controlled trial using a 2 x 3 factorial design. Surgeons at clinical sites in North America, Europe, Australia, and Asia will recruit 2 280 patients who will be centrally randomized into one of the 6 treatment arms (soap + low pressure; soap + gravity flow pressure; soap + high pressure; saline + low pressure; saline + gravity flow pressure; saline + high pressure). The primary outcome of the study is re-operation to promote wound or bone healing, or to treat an infection. This composite endpoint of re-operation includes a narrow spectrum of patient-important procedures: irrigation and debridement for infected wound, revision and closure for wound dehiscence, wound coverage procedures for infected or necrotic wound, bone grafts or implant exchange procedures for established nonunion in patients with postoperative fracture gaps less than 1 cm, intramedullary nail dynamizations in the operating room, and fasciotomies for compartment syndrome. Patients, outcome adjudicators, and data analysts will be blinded. We will compare rates of re-operation at 12 months across soap vs. saline, low pressure vs. high pressure, gravity flow pressure vs. high pressure, and low pressure vs. gravity flow pressure. We will measure function and quality of life with the Short Form-12 (SF-12) and the EuroQol-5 Dimensions (EQ-5D) at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months after initial surgical management, and measure patients' illness beliefs with the Somatic Pre-Occupation and Coping (SPOC) questionnaire at 1 and 6 weeks. We will also compare non-operatively managed infections, wound healing, and fracture healing problems at 12 months after initial surgery. DISCUSSION:This study represents a major international effort to identify a simple and easily applicable strategy for emergency wound management. The importance of the question and the potential to identify a low cost treatment strategy argues strongly for global participation, especially in low and middle income countries such as India and China where disability from traumatic injuries is substantial. TRIAL REGISTRATION:This trial is registered at ClinicalTrials.gov (NCT00788398).
journal_name
BMC Musculoskelet Disordjournal_title
BMC musculoskeletal disordersauthors
Flow Investigators.doi
10.1186/1471-2474-11-85subject
Has Abstractpub_date
2010-05-06 00:00:00pages
85issn
1471-2474pii
1471-2474-11-85journal_volume
11pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:The periprosthetic joint infection (PJI) is a severe complication in the field of arthroplasty. Despite the rising number of primary joint replacements, no unified therapeutic standard has been established for the treatment of PJI yet. METHODS:A survey on the principles of treatment of PJI in Germany was co...
journal_title:BMC musculoskeletal disorders
pub_type: 杂志文章
doi:10.1186/s12891-020-03670-y
更新日期:2020-10-19 00:00:00
abstract:BACKGROUND:Rotational acetabular osteotomy (RAO), Chiari osteotomy and shelf procedure are important treatments to delay the progression of osteoarthritis in developmental dysplasia of hip (DDH) patients, but their biomechanical differences are still unknown. This study was to evaluate the different biomechanical chang...
journal_title:BMC musculoskeletal disorders
pub_type: 杂志文章
doi:10.1186/1471-2474-15-47
更新日期:2014-02-21 00:00:00
abstract:BACKGROUND:Recovery of motor dysfunction is important for patients with incomplete cervical spinal cord injury (SCI). To enhance the recovery of muscle strength, both research and treatments mainly focus on injury of upper motor neurons at the direct injury site. However, accumulating evidences have suggested that SCI ...
journal_title:BMC musculoskeletal disorders
pub_type: 杂志文章
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更新日期:2020-08-15 00:00:00
abstract:BACKGROUND:Several authors reported encouraging results of total hip arthroplasty (THA) for Crowe IV hips performed using shortening osteotomy. However, few papers have documanted the results of THA for Crowe IV hips without shortening osteotomy. The aim of the present study was to assess the long term-results of cemen...
journal_title:BMC musculoskeletal disorders
pub_type: 杂志文章
doi:10.1186/1471-2474-15-72
更新日期:2014-03-10 00:00:00
abstract:BACKGROUND:Clinical guidelines recommend research on sub-groups of patients with low back pain (LBP) but, to date, only few studies have been published. One sub-group of LBP is movement control impairment (MCI) and clinical tests to identify this sub-group have been developed. Also, exercises appear to be beneficial fo...
journal_title:BMC musculoskeletal disorders
pub_type: 杂志文章,随机对照试验
doi:10.1186/s12891-016-0986-y
更新日期:2016-03-22 00:00:00
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pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2013-04-05 00:00:00
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journal_title:BMC musculoskeletal disorders
pub_type: 临床试验,杂志文章
doi:10.1186/1471-2474-12-242
更新日期:2011-10-24 00:00:00
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pub_type: 杂志文章
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journal_title:BMC musculoskeletal disorders
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更新日期:2015-08-21 00:00:00
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journal_title:BMC musculoskeletal disorders
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更新日期:2006-03-16 00:00:00
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journal_title:BMC musculoskeletal disorders
pub_type: 杂志文章,随机对照试验
doi:10.1186/1471-2474-6-27
更新日期:2005-05-30 00:00:00
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pub_type: 杂志文章
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pub_type: 杂志文章,多中心研究
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更新日期:2014-01-16 00:00:00
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更新日期:2020-05-07 00:00:00
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