Pilot Study - Fluid lavage of open wounds: The need for RCT of irrigation approaches .
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by one or more authors of the
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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)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
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
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
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 la domanda di ricerca principale?
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.
Che cosa devo ricordare di più?
There is a possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion.
Come influenzerà l'assistenza ai miei pazienti?
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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