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Meta-Analysis
. 2021 Mar 10;3(3):CD011675.
doi: 10.1002/14651858.CD011675.pub2.

Wound cleansing for treating venous leg ulcers

Niamh Em McLain  1 , Zena Eh Moore  2 , Pinar Avsar  2
Affiliations
Meta-Analysis

Wound cleansing for treating venous leg ulcers

Niamh Em McLain et al. Cochrane Database Syst Rev. .

Abstract
in English, Spanish

Background: Leg ulcers are open skin wounds that occur below the knee but above the foot. The majority of leg ulcers are venous in origin, occurring as a result of venous insufficiency, where the flow of blood through the veins is impaired; they commonly arise due to blood clots and varicose veins. Compression therapy, using bandages or stockings, is the primary treatment for venous leg ulcers. Wound cleansing can be used to remove surface contaminants, bacteria, dead tissue and excess wound fluid from the wound bed and surrounding skin, however, there is uncertainty regarding the effectiveness of cleansing and the best method or solution to use.

Objectives: To assess the effects of wound cleansing, wound cleansing solutions and wound cleansing techniques for treating venous leg ulcers.

Search methods: In September 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Selection criteria: We considered randomised controlled trials (RCTs) comparing wound cleansing with no wound cleansing, or RCTs comparing different wound cleansing solutions, or different wound cleansing techniques.

Data collection and analysis: We screened studies for their appropriateness for inclusion, assessed their risk of bias using the Cochrane 'Risk of bias' tool, and used GRADE methodology to determine the certainty of evidence. Two review authors undertook these tasks independently, using predetermined criteria. We contacted study authors for missing data where possible.

Main results: We included four studies with a total of 254 participants. All studies included comparisons between different types of cleansing solutions, and three of these reported our primary outcomes of complete wound healing or change in ulcer size over time, or both. Two studies reported the secondary outcome, pain. One study (27 participants), which compared polyhexamethylene biguanide (PHMB) solution with saline solution for cleansing venous leg ulcers, did not report any of the review's primary or secondary outcomes. We did not identify any studies that compared cleansing with no cleansing, or that explored comparisons between different cleansing techniques. One study (61 participants) compared aqueous oxygen peroxide with sterile water. We are uncertain whether aqueous oxygen peroxide makes any difference to the number of wounds completely healed after 12 months of follow-up (risk ratio (RR) 1.88, 95% confidence interval (CI) 1.10 to 3.20). Similarly, we are uncertain whether aqueous oxygen peroxide makes any difference to change in ulcer size after eight weeks of follow-up (mean difference (MD) -1.38 cm2, 95% CI -4.35 to 1.59 cm2). Finally, we are uncertain whether aqueous oxygen peroxide makes any difference to pain reduction, assessed after eight weeks of follow-up using a 0 to 100 pain rating, (MD 3.80, 95% CI -10.83 to 18.43). The evidence for these outcomes is of very low certainty (we downgraded for study limitations and imprecision; for the pain outcome we also downgraded for indirectness). Another study (40 participants) compared propyl betaine and polihexanide with a saline solution. The authors did not present the raw data in the study report so we were unable to conduct independent statistical analysis of the data. We are uncertain whether propyl betaine and polihexanide make any difference to the number of wounds completely healed, change in ulcer size over time, or wound pain reduction. The evidence is of very low certainty (we downgraded for study limitations and imprecision). The final study (126 participants) compared octenidine dihydrochloride/phenoxyethanol (OHP) with Ringer's solution. We are uncertain whether OHP makes any difference to the number of wounds healed (RR 0.96, 95% CI 0.53 to 1.72) or to the change in ulcer size over time (we were unable to conduct independent statistical analysis of available data). The evidence is of very low certainty (we downgraded for study limitations and imprecision). None of the studies reported patient preference, ease of use of the method of cleansing, cost or health-related quality of life. In one study comparing propyl betaine and polihexanide with saline solution the authors do not report any adverse events occurring. We are uncertain whether OHP makes any difference to the number of adverse events compared with Ringer's solution (RR 0.58, 95% CI 0.29 to 1.14). The evidence is of very low certainty (we downgraded for study limitations and imprecision).

Authors' conclusions: There is currently a lack of RCT evidence to guide decision making about the effectiveness of wound cleansing compared with no cleansing and the optimal approaches to cleansing of venous leg ulcers. From the four studies identified, there is insufficient evidence to demonstrate whether the use of PHMB solution compared with saline solution; aqueous oxygen peroxide compared with sterile water; propyl betaine and polihexanide compared with a saline solution; or OHP compared with Ringer's solution makes any difference in the treatment of venous leg ulcers. Evidence from three of the studies is of very low certainty, due to study limitations and imprecision. One study did not present data for the primary or secondary outcomes. Further well-designed studies that address important clinical, quality of life and economic outcomes may be important, based on the clinical and patient priority of this uncertainty.

Antecedentes: Las úlceras de la pierna son heridas cutáneas abiertas que se producen por debajo de la rodilla, pero por encima del pie. La mayoría de las úlceras de la pierna son de origen venoso, y se producen como resultado de la insuficiencia venosa, en la que el flujo de sangre a través de las venas se ve afectado; suelen surgir debido a coágulos de sangre y venas varicosas. El tratamiento de compresión (vendas o medias) es el tratamiento principal para las úlceras venosas de la pierna. La limpieza de la herida se puede utilizar para eliminar los contaminantes superficiales, las bacterias, el tejido muerto y el exceso de líquido de la base de la úlcera y de la piel circundante; sin embargo, no se sabe con certeza cuál es la efectividad de la limpieza ni cuál es el mejor método o solución a utilizar.

Objetivos: Evaluar los efectos de la limpieza de heridas, las soluciones de limpieza de heridas y las técnicas de limpieza de heridas para el tratamiento de las úlceras venosas de la pierna. MÉTODOS DE BÚSQUEDA: En septiembre de 2019 se hicieron búsquedas en el Registro especializado del Grupo Cochrane de Heridas (Cochrane Wounds Group), en el Registro Cochrane central de ensayos controlados (CENTRAL); Ovid MEDLINE (incluido In‐Process & Other Non‐Indexed Citations); Ovid Embase y EBSCO CINAHL Plus. También se buscaron estudios en curso y no publicados en los registros de ensayos clínicos, y se examinaron las listas de referencias de los estudios incluidos pertinentes, así como de las revisiones, los metanálisis y los informes de tecnología sanitaria para identificar estudios adicionales. No hubo restricciones en cuanto al idioma, la fecha de publicación ni el contexto de los estudios. CRITERIOS DE SELECCIÓN: Se consideraron los ensayos controlados aleatorizados (ECA) que compararon la limpieza de heridas con ninguna limpieza de heridas, o ECA que compararon diferentes soluciones de limpieza de heridas o diferentes técnicas de limpieza de heridas. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Se examinaron los estudios para determinar si eran adecuados para inclusión, el riesgo de sesgo se evaluó mediante la herramienta Cochrane "Risk of bias" y se utilizó el método GRADE para determinar la certeza de la evidencia. Dos autores de la revisión realizaron estas tareas de forma independiente, utilizando criterios predeterminados. Cuando fue posible, se estableció contacto con los autores de los estudios para obtener los datos faltantes.

Resultados principales: Se incluyeron cuatro estudios con un total de 254 participantes. Todos los estudios incluyeron comparaciones entre diferentes tipos de soluciones de limpieza, y tres de ellos informaron sobre los desenlaces principales de esta revisión, cicatrización completa de la herida o cambio en el tamaño de la úlcera con el tiempo, o ambos. Dos estudios informaron sobre el desenlace secundario de dolor. Un estudio (27 participantes), que comparó la solución de polihexametileno biguanida (PHMB) con el suero fisiológico para la limpieza de las úlceras venosas de la pierna, no informó sobre ninguno de los desenlaces principales ni secundarios de la revisión. No se identificaron estudios que compararan la limpieza con ninguna limpieza, o que explorara comparaciones entre diferentes técnicas de limpieza. Un estudio (61 participantes) comparó el peróxido de oxígeno acuoso con el agua estéril. No hay certeza de que el peróxido de oxígeno acuoso suponga alguna diferencia en el número de heridas completamente cicatrizadas tras 12 meses de seguimiento (razón de riesgos [RR] 1,88; intervalo de confianza [IC] del 95%: 1,10 a 3,20). Del mismo modo, no hay certeza de que el peróxido de oxígeno acuoso suponga alguna diferencia en el cambio del tamaño de la úlcera tras ocho semanas de seguimiento (diferencia de medias [DM] ‐1,38 cm2; IC del 95%: ‐4,35 a 1,59 cm2). Por último, no hay certeza de que el peróxido de oxígeno acuoso suponga alguna diferencia en la reducción del dolor, evaluada tras ocho semanas de seguimiento mediante una calificación del dolor de 0 a 100 (DM 3,80; IC del 95%: ‐10,83 a 18,43). La evidencia para estos desenlaces es de certeza muy baja (se disminuyó la calificación por las limitaciones del estudio y la imprecisión; para el desenlace dolor también se disminuyó la calificación por medidas indirectas). Otro estudio (40 participantes) comparó la propil betaína y la polihexanida con una solución salina. Los autores no presentaron los datos brutos en el informe del estudio, por lo que no fue posible realizar un análisis estadístico independiente de los datos. No se sabe si la propil betaína y la polihexanida suponen alguna diferencia en el número de heridas completamente cicatrizadas, en el cambio del tamaño de la úlcera con el tiempo o en la reducción del dolor de la herida. La evidencia es de certeza muy baja (se disminuyó por las limitaciones del estudio y la imprecisión). El último estudio (126 participantes) comparó el dihidrocloruro de octenidina/fenoxietanol (OHP) con la solución de Ringer. No hay certeza de que el OHP suponga alguna diferencia en el número de heridas cicatrizadas (RR 0,96; IC del 95%: 0,53 a 1,72) ni en el cambio del tamaño de la úlcera con el tiempo (no fue posible realizar un análisis estadístico independiente de los datos disponibles). La evidencia es de certeza muy baja (se disminuyó por las limitaciones del estudio y la imprecisión). Ninguno de los estudios informó sobre la preferencia de los pacientes, la facilidad de uso del método de limpieza, el coste o la calidad de vida relacionada con la salud. En un estudio en el que se compara la propil betaína y la polihexanida con la solución salina, los autores no informaron la aparición de eventos adversos. No hay certeza de que el OHP suponga alguna diferencia en el número de eventos adversos en comparación con la solución de Ringer (RR 0,58; IC del 95%: 0,29 a 1,14). La evidencia es de certeza muy baja (se disminuyó por las limitaciones del estudio y la imprecisión).

Conclusiones de los autores: En la actualidad se carece de evidencia de ECA para guiar la toma de decisiones sobre la efectividad de la limpieza de heridas en comparación con ninguna limpieza y los enfoques óptimos para la limpieza de las úlceras venosas de la pierna. A partir de los cuatro estudios identificados, no hay evidencia suficiente para demostrar si el uso de la solución PHMB en comparación con el suero fisiológico; el peróxido de oxígeno acuoso en comparación con el agua estéril; la betaína propil y la polihexanida en comparación con un suero fisiológico; o el OHP en comparación con la solución de Ringer supone alguna diferencia en el tratamiento de las úlceras venosas de la pierna. La evidencia de tres de los estudios es de certeza muy baja, debido a las limitaciones de los estudios y a la imprecisión. Un estudio no presentó datos para los desenlaces principales ni secundarios. Podría ser importante realizar más estudios bien diseñados que aborden desenlaces clínicos, de calidad de vida y económicos importantes, sobre la base de la prioridad clínica y para el paciente de esta falta de certeza.

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Conflict of interest statement

Niamh McLain (NMcL): none known.

Zena Moore (ZM): has received an honorarium for speaking at professional meetings for Smith & Nephew and Molnlycke.

Pinar Avsar (PA): none known.

Figures

1
1
PRISMA Flowchart
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1: AOP versus Sterile Water, Outcome 1: Wounds Healed ‐ Per Protocol ‐12 Months
1.2
1.2. Analysis
Comparison 1: AOP versus Sterile Water, Outcome 2: Wound Size Reduction (cm2) ‐ 8 Weeks
1.3
1.3. Analysis
Comparison 1: AOP versus Sterile Water, Outcome 3: Pain ‐ ITT ‐ 8 Weeks
2.1
2.1. Analysis
Comparison 2: OHP versus Ringer's Solution, Outcome 1: Wound healing
2.2
2.2. Analysis
Comparison 2: OHP versus Ringer's Solution, Outcome 2: Adverse event
See this image and copyright information in PMC

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References to other published versions of this review

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