Alternative reactive support surfaces (non-foam and non-air-filled) for preventing pressure ulcers
- PMID: 34097764
- PMCID: PMC8179967
- DOI: 10.1002/14651858.CD013623.pub2
Alternative reactive support surfaces (non-foam and non-air-filled) for preventing pressure ulcers
Abstract
Background: Pressure ulcers (also known as injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive surfaces that are not made of foam or air cells can be used for preventing pressure ulcers.
Objectives: To assess the effects of non-foam and non-air-filled reactive beds, mattresses or overlays compared with any other support surface on the incidence of pressure ulcers in any population in any setting.
Search methods: In November 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 We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional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 included randomised controlled trials that allocated participants of any age to non-foam or non-air-filled reactive beds, overlays or mattresses. Comparators were any beds, overlays or mattresses used.
Data collection and analysis: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a non-foam or non-air-filled surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses.
Main results: We included 20 studies (4653 participants) in this review. Most studies were small (median study sample size: 198 participants). The average participant age ranged from 37.2 to 85.4 years (median: 72.5 years). Participants were recruited from a wide range of care settings but were mainly from acute care settings. Almost all studies were conducted in Europe and America. Of the 20 studies, 11 (2826 participants) included surfaces that were not well described and therefore could not be fully classified. We synthesised data for the following 12 comparisons: (1) reactive water surfaces versus alternating pressure (active) air surfaces (three studies with 414 participants), (2) reactive water surfaces versus foam surfaces (one study with 117 participants), (3) reactive water surfaces versus reactive air surfaces (one study with 37 participants), (4) reactive water surfaces versus reactive fibre surfaces (one study with 87 participants), (5) reactive fibre surfaces versus alternating pressure (active) air surfaces (four studies with 384 participants), (6) reactive fibre surfaces versus foam surfaces (two studies with 228 participants), (7) reactive gel surfaces on operating tables followed by foam surfaces on ward beds versus alternating pressure (active) air surfaces on operating tables and subsequently on ward beds (two studies with 415 participants), (8) reactive gel surfaces versus reactive air surfaces (one study with 74 participants), (9) reactive gel surfaces versus foam surfaces (one study with 135 participants), (10) reactive gel surfaces versus reactive gel surfaces (one study with 113 participants), (11) reactive foam and gel surfaces versus reactive gel surfaces (one study with 166 participants) and (12) reactive foam and gel surfaces versus foam surfaces (one study with 91 participants). Of the 20 studies, 16 (80%) presented findings which were considered to be at high overall risk of bias.
Primary outcome: Pressure ulcer incidence We did not find analysable data for two comparisons: reactive water surfaces versus foam surfaces, and reactive water surfaces versus reactive fibre surfaces. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (14/205 (6.8%)) may increase the proportion of people developing a new pressure ulcer compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds (3/210 (1.4%) (risk ratio 4.53, 95% confidence interval 1.31 to 15.65; 2 studies, 415 participants; I2 = 0%; low-certainty evidence). For all other comparisons, it is uncertain whether there is a difference in the proportion of participants developing new pressure ulcers as all data were of very low certainty. Included studies did not report time to pressure ulcer incidence for any comparison in this review. Secondary outcomes Support-surface-associated patient comfort: the included studies provide data on this outcome for one comparison. It is uncertain if there is a difference in patient comfort between alternating pressure (active) air surfaces and reactive fibre surfaces (one study with 187 participants; very low-certainty evidence). All reported adverse events: there is evidence on this outcome for one comparison. It is uncertain if there is a difference in adverse events between reactive gel surfaces followed by foam surfaces and alternating pressure (active) air surfaces applied on both operating tables and hospital beds (one study with 198 participants; very low-certainty evidence). We did not find any health-related quality of life or cost-effectiveness evidence for any comparison in this review.
Authors' conclusions: Current evidence is generally uncertain about the differences between non-foam and non-air-filled reactive surfaces and other surfaces in terms of pressure ulcer incidence, patient comfort, adverse effects, health-related quality of life and cost-effectiveness. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds may increase the risk of having new pressure ulcers compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision-makers. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and adjudicators of the photographs being blinded to group allocation. Further review using network meta-analysis will add to the findings reported here.
Antecedentes: Las úlceras por presión (también conocidas como úlceras y escaras de decúbito) son lesiones localizadas en la piel o en los tejidos blandos subyacentes, o en ambos, causadas por la presión, el cizallamiento o la fricción no aliviados. Las superficies estáticas que no son de espuma o celdas de aire se pueden utilizar para prevenir las úlceras por presión.
Objetivos: Evaluar los efectos de las camas, los colchones o los sobrecolchones estáticos sin espuma y sin aire en comparación con cualquier otra superficie especial para el manejo de la presión (SEMP) o sobre la incidencia de las úlceras por presión en cualquier población y en cualquier contexto. MÉTODOS DE BÚSQUEDA: En noviembre de 2019 se hicieron búsquedas en el Registro especializado del Grupo Cochrane de Heridas (Cochrane Wounds), en el Registro Cochrane central de ensayos controlados (Cochrane Central Register of Controlled Trials, 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 incluyeron los ensayos controlados aleatorizados que asignaron a participantes de cualquier edad a camas, colchones o sobrecolchones estáticos sin espuma y sin aire. Los comparadores fueron todas las camas, sobrecolchones o colchones utilizados. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Al menos dos autores de la revisión evaluaron de forma independiente los ensayos según criterios de inclusión predeterminados. Se realizó la extracción de los datos, la evaluación del riesgo de sesgo mediante la herramienta Cochrane "Risk of bias" y la evaluación de la certeza de la evidencia según el método Grading of Recommendations, Assessment, Development and Evaluations. Si se comparaba una superficie sin espuma o sin aire con superficies que no estaban claramente especificadas, se registraba y describía el estudio incluido, pero no se tenía en cuenta en ningún análisis de datos.
Resultados principales: En esta revisión se incluyeron 20 estudios (4653 participantes). La mayoría de los estudios eran pequeños (mediana del tamaño muestral de los estudios: 198 participantes). La edad promedio de los participantes varió entre 37,2 y 85,4 años (mediana: 72,5 años). Los participantes se reclutaron en una amplia variedad de ámbitos asistenciales, pero principalmente en ámbitos de cuidados intensivos y de agudos. Casi todos los estudios se realizaron en Europa y América. De los 20 estudios, 11 (2826 participantes) incluían superficies que no estaban bien descritas y, por lo tanto, no se podían clasificar completamente. Se resumieron los datos de las 12 comparaciones siguientes: (1) superficies de agua estáticas versus superficies de aire de presión alternante (activas) (tres estudios con 414 participantes), (2) superficies de agua estáticas versus superficies de espuma (un estudio con 117 participantes), (3) superficies de agua estáticas versus superficies de aire estáticas (un estudio con 37 participantes), (4) superficies de agua estáticas versus superficies de fibras estáticas (un estudio con 87 participantes), (5) superficies de fibras estáticas versus superficies de aire de presión alternante (activas) (cuatro estudios con 384 participantes), (6) superficies de fibras estáticas versus superficies de espuma (dos estudios con 228 participantes), (7) superficies de gel estáticas en las mesas de operaciones, seguidas de superficies de espuma en las camas de las salas, versus superficies de aire de presión alternante (activas) en las mesas de operaciones y posteriormente en las camas de las salas (dos estudios con 415 participantes), (8) superficies de gel estáticas versus superficies de aire estáticas (un estudio con 74 participantes) (9) superficies de gel estáticas versus superficies de espuma (un estudio con 135 participantes), (10) superficies de gel estáticas versus superficies de gel estáticas (un estudio con 113 participantes), (11) superficies de espuma y gel estáticas versus superficies de gel estáticas (un estudio con 166 participantes) y (12) superficies de espuma y gel estáticas versus superficies de espuma (un estudio con 91 participantes). De los 20 estudios, 16 (80%) presentaron resultados que se consideraron con alto riesgo general de sesgo. Desenlace principal: incidencia de las úlceras por presión No se encontraron datos analizables para dos comparaciones: superficies de agua estáticas versus superficies de espuma, ni superficies de agua estáticas versus superficies de fibras estáticas. Las superficies de gel estáticas utilizadas en las mesas de operaciones seguidas de las superficies de espuma aplicadas en las camas de hospital (14/205 [6,8%]) podrían aumentar la proporción de personas que presentan una nueva úlcera por presión en comparación con las superficies de aire de presión alternante (activas) aplicadas en las mesas de operaciones y en las camas de hospital (3/210 [1,4%]) (razón de riesgos 4,53; intervalo de confianza del 95%: 1,31 a 15,65; dos estudios, 415 participantes; I2 = 0%; evidencia de certeza baja). Para todas las demás comparaciones, no hay certeza de que haya una diferencia en la proporción de participantes que presentan nuevas úlceras por presión, ya que todos los datos eran de certeza muy baja. Los estudios incluidos no informaron el tiempo hasta la incidencia de las úlceras por presión para ninguna comparación en esta revisión. Desenlaces secundarios Comodidad del paciente asociada con la SEMP: los estudios incluidos proporcionan datos sobre este desenlace para una comparación. No está claro si existe una diferencia en la comodidad del paciente entre las superficies de aire de presión alternante (activas) y las superficies de fibras estáticas (un estudio con 187 participantes; evidencia de certeza muy baja). Todos los eventos adversos informados: hay evidencia sobre este desenlace para una comparación. No se sabe si existe una diferencia en los eventos adversos entre las superficies de gel estáticas seguidas de superficies de espuma y las superficies de aire de presión alternante (activas) aplicadas tanto en las mesas de operaciones como en las camas de hospital (un estudio con 198 participantes; evidencia de certeza muy baja). No se encontró evidencia acerca de la calidad de vida relacionada con la salud ni de la coste‐efectividad para ninguna comparación en esta revisión.
Conclusiones de los autores: Por lo general no se desconoce la evidencia actual sobre las diferencias entre las superficies estáticas sin espuma y sin aire y otras superficies en términos de la incidencia de las úlceras por presión, la comodidad del paciente, los efectos adversos, la calidad de vida relacionada con la salud y la coste‐efectividad. Las superficies de gel estáticas utilizadas en las mesas de operaciones, seguidas de las superficies de espuma aplicadas en las camas de hospital, podrían aumentar el riesgo de aparición de nuevas úlceras por presión en comparación con las superficies de aire de presión alternante (activas) aplicadas en las mesas de operaciones y en las camas de hospital. Los estudios de investigación futuros en este campo deberían considerar la evaluación de las SEMP más importantes desde la perspectiva de aquellos que toman decisiones. En los estudios futuros se deben considerar los desenlaces de tiempo hasta el evento, la evaluación cuidadosa de los eventos adversos y la evaluación de la coste‐efectividad a nivel de ensayo. Los ensayos deben estar diseñados para minimizar el riesgo de sesgo de detección; por ejemplo, con el uso de fotografía digital y el cegamiento de los adjudicatarios de las fotografías a la asignación a los grupos. Una revisión posterior mediante metanálisis en red ampliará los resultados aquí proporcionados.
Copyright © 2021 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.
Conflict of interest statement
Chunhu Shi: I received research funding from the National Institute for Health Research (NIHR) (Research for Patient Benefit, Evidence synthesis for pressure ulcer prevention and treatment, PB‐PG‐1217‐20006). I received support from the Tissue Viability Society to attend conferences unrelated to this work. The Doctoral Scholar Awards Scholarship and Doctoral Academy Conference Support Fund (University of Manchester) also supported a PhD and conference attendance respectively, both were unrelated to this work.
Jo Dumville: I am Chief Investigator on a National Institute for Health Research grant that funded the conduct of this review (Research for Patient Benefit, Evidence synthesis for pressure ulcer prevention and treatment, PB‐PG‐1217‐20006). This research was co‐funded by the National Institute for Health Research Manchester Biomedical Research Centre and partly funded by the National Institute for Health Research Applied Research Collaboration Greater Manchester.
Nicky Cullum: I am Co‐investigator on a National Institute for Health Research grant that funded the conduct of this review (Research for Patient Benefit, Evidence synthesis for pressure ulcer prevention and treatment, PB‐PG‐1217‐20006). This research was co‐funded by the National Institute for Health Research Manchester Biomedical Research Centre, and partly funded by the National Institute for Health Research Applied Research Collaboration Greater Manchester.
My previous and current employers received research grant funding from the NHS Research and Development programme and subsequently the NIHR for previous versions of this review. The funders had no role in the conduct of the review. My previous employer received research grant funding from the NIHR for an RCT comparing different alternating pressure air surfaces for pressure ulcer prevention. This RCT (for which I was the Chief Investigator) was not eligible for inclusion in this review.
Sarah Rhodes: my salary is funded from three NIHR grants and a grant from Greater Manchester Cancer.
Elizabeth McInnes: none known.
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- Bliss MR, Thomas JM. An investigative approach. An overview of randomised controlled trials of alternating pressure supports. Professional Nurse (London, England) 1993;8(7):437-44. [PMID: ] - PubMed
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Branom 2001 {published data only}
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- Brown SJ. Bed surfaces and pressure sore prevention: an abridged report. Orthopedic Nursing 2001;20(4):38-40. [PMID: ] - PubMed
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- Cadue JF, Karolewicz S, Tardy C, Barrault C, Robert R, Pourrat O. Prevention of heel pressure sores with a foam body-support device. A randomized controlled trial in a medical intensive care unit [Efficacite de supports anatomiques en mousse pour la prevention des escarres de talons. Etude controlee randomisee en reanimation medicale]. Presse Medicale (Paris, France: 1983) 2008;37(1 Pt 1):30-6. [PMID: ] - PubMed
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Cassino 2013b {published data only}
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Chou 2013 {published data only}
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- Demarre L, Beeckman D, Vanderwee K, Defloor T, Grypdonck M, Verhaeghe S. Multi-stage versus single-stage inflation and deflation cycle for alternating low pressure air mattresses to prevent pressure ulcers in hospitalised patients: a randomised-controlled clinical trial. International Journal of Nursing Studies 2012;49(4):416-26. [PMID: ] - PubMed
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- Devine B. Alternating pressure air mattresses in the management of established pressure sores. Journal of Tissue Viability 1995;5(3):94-8.
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- Ferrell BA, Keeler E, Siu AL, Ahn SH, Osterweil D. Cost-effectiveness of low-air-loss beds for treatment of pressure ulcers. Journals of Gerontology. Series A, Biological Sciences and Medical Sciences 1995;50(3):M141-6. [PMID: ] - PubMed
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- Feuchtinger J, De Bie R, Dassen T, Halfens R. A 4-cm thermoactive viscoelastic foam pad on the operating room table to prevent pressure ulcer during cardiac surgery. Journal of Clinical Nursing 2006;15(2):162-7. [PMID: ] - PubMed
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- Finnegan MJ, Gazzerro L, Finnegan JO, Lo P. Comparing the effectiveness of a specialized alternating air pressure mattress replacement system and an air-fluidized integrated bed in the management of post-operative flap patients: a randomized controlled pilot study. Journal of Tissue Viability 2008;17(1):2-9. - PubMed
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- Fleischer I, Bryant D. Evaluating replacement mattresses. Nursing Management 1997;28(8):38-41. [PMID: ] - PubMed
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Gazzerro 2008 {published data only}
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- Gazzerro L, Finnegan M. Comparing the effectiveness of alternating air pressure mattress replacement systems and air fluidized integrated beds in the management of flap and graft patients: ten case studies. Scientific and Clinical Abstracts from the 40th Annual Wound, Ostomy and Continence Nurses Annual Conference. Journal of Wound, Ostomy, and Continence Nursing 2008;35(3):S63.
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- Gebhardt K, Bliss MR. A controlled study to compare the efficacy, practicability and cost of pressure relieving supports to prevent and heal pressure sores. In: 2nd European Conference on Advances in Wound Management; 1992 October 20-23; Harrogate (UK). 1993:166.
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- Gebhardt KS, Bliss MR, Winwright PL. A randomised controlled trial to compare the efficacy of alternating and constant low pressure supports for preventing pressure sores in an intensive care unit (ICU). Clinical Science 1994;86(S30):39P.
Gebhardt 1996 {published data only}
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- Gebhardt KS, Bliss MR, Winwright PL, Thomas J. Pressure-relieving supports in an ICU. Journal of Wound Care 1996;5(3):116-21. - PubMed
Geelkerken 1994 {published data only}
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- Geelkerken RH, Breslau PJ, Hermans J, Wille J, Hofman A, Hamming JJ. Anti-decubitus mattress [Anti-decubitusmatrassen]. Nederlands Tijdschrift voor Geneeskunde 1994;138(36):1834; author reply 1834-5. [PMID: ] - PubMed
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- Gray D. A randomised clinical trial of two foam mattresses. Aberdeen Royal Hospitals NHS Trust. Medical Support System 1994.
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Greer 1988 {published data only}
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- Gunningberg L, Lindholm C, Carlsson M, Sjoden PO. Reduced incidence of pressure ulcers in patients with hip fractures: a 2-year follow-up of quality indicators. International Journal for Quality in Health Care 2001;13(5):399-407. [PMID: ] - PubMed
Haalboom 1994 {published data only}
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Holzgreve 1993 {published data only}
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Hommel 2008 {published data only}
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- Hoskins A. Alternating pressure mattresses were more cost effective than alternating pressure overlays for preventing pressure ulcers. Evidence-Based Nursing 2007;10(1):23. [PMID: ] - PubMed
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- Hoskins A. Similar proportions of patients developed pressure ulcers on alternating pressure overlays and alternating pressure mattresses. Evidence-Based Nursing 2007;10(1):22. [PMID: ] - PubMed
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- Hungerford K. A specially designed foam mattress replacement reduced pressure ulcers in nursing home residents. Evidence-Based Nursing 1998;1(2):51.
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Ismail 2001 {published data only}
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- Ismail ZBM. Comparative study between the use of a pressure relieving overlay mattress and other mattresses commonly used by homebound patients in the community. Singapore Nursing Journal 2001;28(2):13-6.
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- Jiang Q, Li X, Zhang A, Guo Y, Liu Y, Liu H, et al. Multicenter comparison of the efficacy on prevention of pressure ulcer in postoperative patients between two types of pressure-relieving mattresses in China. International Journal of Clinical and Experimental Medicine 2014;7(9):2820-7. [PMID: ] - PMC - PubMed
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Maklebust 1988 {published data only}
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- Maklebust J, Brunckhorst L, Cracchiolo-Caraway A, Ducharme MA, Dundon R, Panfilli R, et al. Pressure ulcer incidence in high-risk patients managed on a special three-layered air cushion. Decubitus 1988;1(4):30-40. [PMID: ] - PubMed
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- Malbrain M, Hendriks B, Wijnands P, Denie D, Jans A, Vanpellicom J, et al. A pilot randomised controlled trial comparing reactive air and active alternating pressure mattresses in the prevention and treatment of pressure ulcers among medical ICU patients. Journal of Tissue Viability 2010;19(1):7-15. [PMID: ] - PubMed
Marutani 2019 {published data only}
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- JPRN-UMIN000035568. Evaluation of pressure ulcer prevention and QOL for using dual-fit-air-cell-mattresses. www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000035568.
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- Mendoza RA, Lorusso GA, Ferrer DA, Helenowski IB, Liu J, Soriano RH, et al. A prospective, randomised controlled trial evaluating the effectiveness of the fluid immersion simulation system vs an air-fluidised bed system in the acute postoperative management of pressure ulcers: a midpoint study analysis. International Wound Journal 2019;16(4):989-99. - PMC - PubMed
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NCT01402765 {published data only}
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NCT02565797 {published data only}
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NCT02634892 {published data only}
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NCT02735135 {published data only}
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Rithalia 1995 {published data only}
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Russell 2000b {published data only}
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Shakibamehr 2019 {published data only}
Sharp 2007 {published data only}
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