Pilot Study - Fluid lavage of open wounds: The need for RCT of irrigation approaches .
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)?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
4/4
Aleatorización
4/4
Medición de resultados
4/4
Inclusión / exclusión
4/4
Descripción de la terapia
4/4
Estadísticas
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
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.
Was war die wichtigste Forschungsfrage?
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.
Was sollte ich mir besonders merken?
There is a possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
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.
HAFTUNGSAUSSCHLUSS
Der Inhalt dieser Seite dient nur zu Informationszwecken und ist nicht als Ersatz für professionelle medizinische Beratung, Diagnose oder Behandlung gedacht. Wenn Sie eine medizinische Behandlung benötigen, wenden Sie sich immer an Ihren Arzt oder suchen Sie die nächstgelegene Notaufnahme auf. Die Meinungen, Überzeugungen und Standpunkte, die von den Personen auf dieser Seite geäußert werden, spiegeln nicht die Meinungen, Überzeugungen und Standpunkte von OrthoEvidence wider.
0 von 4 monatliche KOSTENLOSE Artikel freigeschaltet
