TRAUMA
Fluid Lavage of Open Wounds (FLOW): A Multicenter, Blinded,Factorial Pilot Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(9):75 J Trauma. 2011 Sep;71(3):596-606.Exclusive Author Interview
Dr. Brad Petrisor discusses a pilot study examining the fluid lavage of open wounds
111 patients at different centers across the world with open fracture wound were randomized to be treated with either castile soap solution or normal saline and either high- or low-pressure pulsatile lavage. The primary composite outcome of reoperation, measured at 12 months after initial operative procedure, included infection, wound healing problems, and nonunion. Secondary outcomes included the functional outcomes scores. No statistically significant difference was found between treatments because of the low adverse event rate, but data suggests that the low pressure lavage may be beneficial in decreasing the infection risk, this yet remains to be proven in a bigger RCT.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Open fractures can be challenging to treat because of associated morbidity resulting from delayed union, nonunion, and infection. A thorough wash out and debridement are the gold standard treatments for preventing infection. There have been smaller studies suggesting different lavage fluids and disinfectants for irrigation to be better than saline. Also several products in market are available with variable pressures for lavage. However, there is still a dearth of randomized trials comparing commonly used irrigating solutions or even irrigating technique. This study compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.
主な研究課題は何ですか？
Does the irrigation fluid and the pressure, at which it is run on an open fracture wash out, lead to differences in infection rates and rates of re-operation(s)?
重要な知見は？
- 23% of patients in the castile soap group and 24% of patients in the saline group had a primary outcome event (hazard ratio, 0.91, 95% confidence interval: 0.4-2.00, p= 0.52).
- 28% of patients in the high-pressure group and 19% of patients in the low-pressure group had a primary outcome event (hazard ratio 0.55, 95% confidence interval: 0.24-1.27, p= 0.17).
- Functional outcome scores showed no significant differences at any time point between groups.
最も覚えておくべきことは？
There is a possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion.
それが私の患者ケアにどのように影響するか？
There is a good possibility that the use of low pressure may decrease the re-operation rate for infection, wound healing problems, or nonunion; however, a larger study is required to ascertain this precisely.
免責事項
このページに記載されている内容は、情報提供のみを目的としたものであり、専門的な医療アドバイス、診断、治療の代わりとなるものではありません。治療が必要な場合は、必ず医師の診断を仰ぐか、最寄りの救急外来を受診してください。このページに記載されている内容に関して個人が表明した意見、信念、見解は、OrthoEvidenceの意見、信念、見解を反映するものではありません。
0の4 月間無料記事のロック解除
