Pilot Study - Fluid lavage of open wounds: The need for RCT of irrigation approaches .
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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)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
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
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
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.
Qual era a principal questão de investigação?
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)?
- 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.
De que é que me devo lembrar mais?
There is a possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion.
Como é que isto afectará o tratamento dos meus doentes?
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.
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