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Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures.

ABSTRACT: 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.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.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.This trial is registered at ClinicalTrials.gov (NCT00788398).

SUBMITTER: Flow Investigators

PROVIDER: S-EPMC2887775 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

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Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures.

BMC musculoskeletal disorders 20100506

<h4>Background</h4>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 ope ...[more]

PMID: 20459600

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Project description:BackgroundAlthough many studies report the incidence and prevalence of surgical site infections (SSIs) after open fractures, there is limited information on the treatment and subsequent outcomes of superficial SSIs in patients with open fractures. Additionally, clinical studies describing the factors that are associated with persistent infection after nonoperative treatment with antibiotics for patients with superficial SSIs are lacking.Questions/purposesTherefore, we asked: (1) What proportion of patients with superficial SSIs after open fracture treatment developed persistent infection after nonoperative treatment (that is, treatment with antibiotics alone)? (2) What risk factors are associated with SSIs that do not resolve with nonoperative (antibiotic) treatment? As a secondary objective, we planned to analyze the microbiological information about participants wound cultures, when these were available, and the proportion of positive cultures for patients whose SSIs were not resolved by antibiotics alone.MethodsThis is a secondary analysis of the Fluid Lavage of Open Wounds (FLOW) trial dataset. The FLOW trial included 2445 patients with operatively managed open fractures. FLOW participants who had a nonoperatively managed superficial SSI diagnosed in the 12 months post-fracture were included in this analysis. Superficial SSIs were diagnosed in 168 participants within 12 months of their fracture. Of these, 83% (139) had their superficial SSI treated with antibiotics alone. Participants were grouped into two categories: (1) 97 participants whose treatment with antibiotics alone resolved the superficial SSI and (2) 42 participants whose treatment with antibiotics alone did not resolve the SSI (defined as undergoing surgical management or the SSI being unresolved at latest follow-up [12-months post-fracture for the FLOW trial]). Of the participants whose treatment with antibiotics alone resolved the SSI, 92% (89 of 97) had complete follow-up, 6% (6 of 97) were lost to follow-up before 12 months, 1% (1 of 97) withdrew consent from the study before 12 months, and 1% (1 of 97) experienced mortality before 12 months. Of the participants whose treatment with antibiotics alone did not resolve the SSI, 90% (38 of 42) had complete follow-up, 7% (3 of 42) were lost to follow-up before 12 months, and 2% (1 of 42) withdrew consent from the study before 12 months. A logistic binary regression analysis was conducted to identify factors associated with persistent infection despite superficial SSI antibiotic treatment. Based on biologic rationale and previous evidence, we identified a priori 13 potential factors (corresponding to 14 levels) to be included in the regression model.ResultsThe antibiotic treatment resolved the superficial SSI in 70% (97 of 139) of patients and did not resolve the SSI in 30% (42 of 139). After controlling for potential confounding variables, such as age, fracture severity, and time from injury to initial surgical irrigation and débridement, superficial SSIs diagnosed later in follow-up were associated with antibiotics not resolving the SSI (odds ratio 1.05 [95% CI 1.004 to 1.009] for every week of follow-up; p = 0.03). Sex, fracture pattern, and wound size were not associated with antibiotics not resolving the SSI.ConclusionsOur secondary analysis of prospectively collected FLOW data suggests that antibiotics alone can be an appropriate treatment option when treating superficial SSIs after an open fracture wound, especially when promptly diagnosed. Further research with longer follow-up time is needed to better identify the natural history of superficial SSIs and possibly some dormant or subclinical infections to help clinicians in the treatment decision-making process.Level of evidenceLevel III, therapeutic study.

Project description:Orthogeriatric co-management (OGCM) may provide benefits for geriatric fragility fracture patients in terms of more frequent osteoporosis treatment and fewer re-fractures. Yet, we did not find higher costs in OGCM hospitals for re-fractures or antiosteoporotic medication for most fracture sites within 12 months, although antiosteoporotic medication was more often prescribed.PurposeEvidence suggests benefits of orthogeriatric co-management (OGCM) for hip fracture patients. Yet, evidence for other fractures is rare. The aim of our study was to conduct an evaluation of economic and health outcomes after the German OGCM for geriatric fragility fracture patients.MethodsThis retrospective cohort study was based on German health and long-term care insurance data. Individuals were 80 years and older, sustained a fragility fracture in 2014-2018, and were treated in hospitals certified for OGCM (ATZ group), providing OGCM without certification (OGCM group) or usual care (control group). Healthcare costs from payer perspective, prescribed medications, and re-fractures were investigated within 6 and 12 months. We used weighted gamma and two-part models and applied entropy balancing to account for the lack of randomization. All analyses were stratified per fracture site.ResultsWe observed 206,273 patients within 12-month follow-up, of whom 14,100 were treated in ATZ, 133,353 in OGCM, and 58,820 in other hospitals. Total average inpatient costs per patient were significantly higher in the OGCM and particularly ATZ group for all fracture sites, compared to control group. We did not find significant differences in costs for re-fractures or antiosteoporotic medication for most fracture sites, although antiosteoporotic medication was significantly more often observed in the OGCM and particularly ATZ group for hip, pelvic, and humerus fractures.ConclusionThe observed healthcare costs were higher in ATZ and OGCM hospitals within 12 months. Antiosteoporotic medication was prescribed more often in both groups for most fracture sites, although the corresponding medication costs did not increase.

Dataset Information

Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures.

Publications

Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures.

Similar Datasets

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