Compression for venous leg ulcers
- PMID: 23152202
- PMCID: PMC7068175
- DOI: 10.1002/14651858.CD000265.pub3
Compression for venous leg ulcers
Abstract
Background: Up to one percent of people in industrialised countries will suffer from a leg ulcer at some time. The majority of these leg ulcers are due to problems in the veins, resulting in an accumulation of blood in the legs. Leg ulcers arising from venous problems are called venous (or varicose or stasis) ulcers. The main treatment is the application of a firm compression garment (bandage or stocking) in order to aid venous return. There is a large number of compression garments available and it was unclear whether they are effective in treating venous ulcers and, if so, which method of compression is the most effective.
Objectives: To undertake a systematic review of all randomised controlled trials (RCTs) evaluating the effects on venous ulcer healing of compression bandages and stockings.Specific questions addressed by the review are:1. Does the application of compression bandages or stockings aid venous ulcer healing? 2. Which compression bandage or stocking system is the most effective?
Search methods: For this second update we searched: the Cochrane Wounds Group Specialised Register (31 May 2012); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 5, 2012); Ovid MEDLINE (1950 to May Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations 30 May 2012); Ovid EMBASE (1980 to 2012 Week 21); and EBSCO CINAHL (1982 to 30 May 2012). No date or language restrictions were applied.
Selection criteria: RCTs recruiting people with venous leg ulceration that evaluated any type of compression bandage system or compression stockings were eligible for inclusion. Eligible comparators included no compression (e.g. primary dressing alone, non-compressive bandage) or an alternative type of compression. RCTs had to report an objective measure of ulcer healing in order to be included (primary outcome for the review). SECONDARY OUTCOMES of the review included ulcer recurrence, costs, quality of life, pain, adverse events and withdrawals. There was no restriction on date, language or publication status of RCTs.
Data collection and analysis: Details of eligible studies were extracted and summarised using a data extraction table. Data extraction was performed by one review author and verified independently by a second review author.
Main results: Forty-eight RCTs reporting 59 comparisons were included (4321 participants in total). Most RCTs were small, and most were at unclear or high risk of bias. Duration of follow-up varied across RCTs. Risk ratio (RR) and other estimates are shown below where RCTs were pooled; otherwise findings refer to a single RCT.There was evidence from eight RCTs (unpooled) that healing outcomes (including time to healing) are better when patients receive compression compared with no compression.Single-component compression bandage systems are less effective than multi-component compression for complete healing at six months (one large RCT).A two-component system containing an elastic bandage healed more ulcers at one year than one without an elastic component (one small RCT).Three-component systems containing an elastic component healed more ulcers than those without elastic at three to four months (two RCTs pooled), RR 1.83 (95% CI 1.26 to 2.67), but another RCT showed no difference between groups at six months.An individual patient data meta-analysis of five RCTs suggested significantly faster healing with the four-layer bandage (4LB) than the short stretch bandage (SSB): median days to healing estimated at 90 and 99 respectively; hazard ratio 1.31 (95% CI 1.09 to 1.58).High-compression stockings are associated with better healing outcomes than SSB at two to four months: RR 1.62 (95% CI 1.26 to 2.10), estimate from four pooled RCTs.One RCT suggested better healing outcomes at 16 months with the addition of a tubular device plus single elastic bandage to a base system of gauze and crepe bandages when compared with two added elastic bandages. Another RCT had three arms; when one or two elastic bandages were added to a base three-component system that included an outer tubular layer, healing outcomes were better at six months for the two groups receiving elastic bandages.There is currently no evidence of a statistically significant difference for the following comparisons:⋅alternative single-component compression bandages (two RCTs, unpooled);⋅two-component bandages compared with the 4LB at three months (three RCTs pooled);⋅alternative versions of the 4LB for complete healing at times up to and including six months (three RCTs, unpooled);⋅4LB compared with paste bandage for complete healing at three months (two RCTs, pooled), six months or one year (one RCT for each time point);⋅adjustable compression boots compared with paste bandages for the outcome of change in ulcer area at three months (one small RCT);⋅adjustable compression boots compared with the 4LB with respect to complete healing at three months (one small RCT);⋅single-layer compression stocking compared with paste bandages for outcome of complete healing at four months (one small RCT) and 18 months (another small RCT);⋅low compression stocking compared with SSB for complete healing at three and six months (one small RCT);⋅compression stockings compared with a two-component bandage system and the 4LB for the outcome of complete healing at three months (one small, three-armed RCT); and,⋅tubular compression compared with SSB (one small RCT) for complete healing at three months.
Secondary outcomes: 4LB was more cost-effective than SSB. It was not possible to draw firm conclusions regarding other secondary outcomes including recurrence, adverse events and health-related quality of life.
Authors' conclusions: Compression increases ulcer healing rates compared with no compression. Multi-component systems are more effective than single-component systems. Multi-component systems containing an elastic bandage appear to be more effective than those composed mainly of inelastic constituents. Two-component bandage systems appear to perform as well as the 4LB. Patients receiving the 4LB heal faster than those allocated the SSB. More patients heal on high-compression stocking systems than with the SSB. Further data are required before the difference between high-compression stockings and the 4LB can be established.
Conflict of interest statement
Nicky Cullum, Susan O'Meara and Jo Dumville receive funding from the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme. This study presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP‐PG‐0407‐10428). The views expressed in this review are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Nicky Cullum is an NIHR Senior Investigator.
Nicky Cullum was Principal Investigator for one of the trials included in this review (Iglesias 2004); this trial was commissioned after the first version of this review was completed. Nicky Cullum is currently Co‐Investigator on the UK NIHR HTA Programme VenUS IV trial which will be eligible for a future update of this review.
Andrea Nelson was co‐applicant and trial co‐ordinator for one of the trials included in this review (Iglesias 2004); this trial was commissioned after the first version of this review was completed. Andrea Nelson was trial co‐ordinator and author of the main publication for one of the trials included in this review (Nelson 2007a).
Figures
Update of
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Compression for venous leg ulcers.Cochrane Database Syst Rev. 2009 Jan 21;(1):CD000265. doi: 10.1002/14651858.CD000265.pub2. Cochrane Database Syst Rev. 2009. Update in: Cochrane Database Syst Rev. 2012 Nov 14;11:CD000265. doi: 10.1002/14651858.CD000265.pub3. PMID: 19160178 Updated.
Comment in
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Compression improves healing of venous leg ulcers compared with no compression, with differences between different compression systems.Evid Based Nurs. 2013 Jul;16(3):94. doi: 10.1136/eb-2012-101201. Epub 2013 Feb 23. Evid Based Nurs. 2013. PMID: 23435371 No abstract available.
References
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- Taradaj J, Franek A, Brzezinska‐Wcislo L, Blaszczak E, Polak A. Randomized trial of medical compression stockings versus two‐layer short‐stretch bandaging in the management of venous leg ulcers. Phlebologie 2009;38(4):157‐63.
Taylor 1998 {published data only}
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- Taylor A. A prospective study to compare healing rates and associated treatment costs for current management of venous leg ulcers in the community and a four‐layer compression bandage regime. Proceedings of the 4th European Conference on Advances in Wound Management. London: Macmillan Magazines, 1995:199‐200.
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- Taylor A, Taylor R, Marcuson R. Comparative healing rates and cost of conventional and four‐layer treatment of venous ulcers.. Phlebology 1995;10:85.
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- Taylor AD, Taylor RJ, Marcuson RW. Prospective comparison of healing rates and therapy costs for conventional and four layer high compression bandaging treatments of venous leg ulcers. Phlebology 1998;13:20‐4.
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- Taylor AD, Taylor RJ, Marcusson RW. Prospective comparison of healing rates and therapy costs for conventional and four layer compression bandaging treatments of venous leg ulcers. Surgical Directorate, Central Manchester Healthcare NHS Trust.
Travers 1992 {published data only}
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- Travers JP, Dalziel KL, Makin GS. Assessment of a new one‐layer adhesive bandaging method in maintaining prolonged limb compression and effects on venous ulcer healing. Phlebology 1992;7:59‐63.
Ukat 2003 {published and unpublished data}
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- Ukat A, Konig M, Vanscheidt W, Münter K‐C. Short‐stretch versus multilayer compression for venous leg ulcers: a comparison of healing rates. Journal of Wound Care 2003;12(4):139‐43. - PubMed
Vowden 2000 {published and unpublished data}
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- Vowden K. A randomized study comparing compliance, healing and complications from three alternative 4LB regimens in the treatment of venous leg ulcers. 9th European Conference on Advances in Wound Management; 9‐11 November, 1999; Harrogate, UK. 1999.
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- Vowden KR, Mason A, Wilkinson D, Vowden P. Comparison of the healing rates and complications of three 4LB regimens. Journal of Wound Care 2000;9(6):269‐72. - PubMed
Wilkinson 1997 {published and unpublished data}
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Zuccarelli 1997 {published and unpublished data}
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References to studies excluded from this review
Alvarez 2005 {published data only}
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- Alvarez O, Markowitz L, Booker J, Rogers R, Waltrous L, Patel M. A randomized clinical trial to evaluate healing of chronic venous ulcers in ambulatory patients treated with modified unna's boot and four layer compression bandage. European Wound Management Association Conference; 2005, 15‐17 September; Stuttgart, Germany. 2005.
Baccaglini 1998 {published data only}
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- Baccaglini U, Giraldi E, Spreafico G, Sorrentino P, Castoro C, Penzo S, et al. Evaluation of the Jobst UlcerCare system for the treatment of venous ulcers. Phlebology 1998;13(4):163‐5.
Blair 1988 {published data only}
Brizzio 2006 {published data only}
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- Brizzio EO, Blttler W, Rossi G, Chirinos A, Cantero I, Idiazabal G, et al. Healing venous leg ulcers with different modalities of leg compression. Phlebologie 2006;35:349‐55.
Cameron 1996 {published data only}
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- Cameron J, Hofman D, Poore S, Duby T, Cherry G, Ryan T. A comparative study of two bandage systems. Proceedings of the 3rd European Conference on Advances in Wound Management. London: Macmillan Magazines, 1994:168.
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Cherry 1990 {published data only}
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- Cherry G. Clinical comparison of a new compression bandage. Nursing Standard 1990;8 (Suppl):8‐11. - PubMed
Falanga 1998 {published data only}
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- Falanga V, Margolis D, Alvarez O, Auletta M, Maggiacomo F, Altman M, et al. Rapid healing of venous ulcers and lack of clinical rejection with an allogenic cultured human skin equivalent. Archives of Dermatology 1998;134:293‐300. - PubMed
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Fuessl 2009 {published data only}
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Hamel‐Desnos 2010 {published data only}
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Heinen 2010 {published data only}
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Hjerppe 2010 {published data only}
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Horakova 1994 {published data only}
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Ivanovic 2011 {published data only}
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Jull 2009 {published data only}
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Jünger 2006 {published data only}
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Kucharzewski 2003 {published data only}
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Kuznetsov 2009 {published data only}
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Lee 2009 {published data only}
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Luo 2009 {published data only}
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Marston 1999 {published data only}
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Nissinen‐Paatsamala 1995 {published data only}
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Northeast 1990 {published and unpublished data}
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- Northeast ADR, Layer GT, Wilson NM, Browse NL, Burnand KG. Increased compression expedites venous ulcer healing. Royal Society of Medicine Venous Forum, 1990 October Meeting. 1990.
Olofsson 1996 {published data only}
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- Olofsson B, Ljunghall K, Nordin‐Bjorklund K, Sorensen S, Leppert J. Two therapeutic models in venous leg ulcers are compared: better results with optimized compression [Optimerad kompression ger battre resultat]. Lakartidningen 1996;93(51‐52):4752‐4. - PubMed
Partsch 2008a {published data only}
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Robson 2004 {published data only}
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- Brennan M, Serena TE, Hanft J, Snyder R. Patients with venous leg ulcerations have diminished quality of life: analysis of a multi‐centre randomized clinical trial. The Symposium on Advanced Wound Care and the Wound Healing Society. 2010, April 17‐20.
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Russo 1999 {published data only}
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- Russo A, Roberta C. Multi‐layer versus two‐layer bandage system in the treatment of venous leg ulcers. A comparative study. 9th European Conference on Advances in Wound Management; 1999, 9‐11 November; Harrogate UK. 1999.
Sabolinski 1995 {published data only}
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Scriven 2000 {published data only}
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Smith Strom 2006 {published data only}
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Szewczyk 2009 {published data only}
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- Jawien A, Szewczky MT, Banaszkiewicz Z, Moscicka P, Hancke E. Pain associated with venous ulcers and its relation to dynamics of wound healing. EWMA Journal 2010;10(2):42.
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Torra i Bou 2003 {published data only}
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- Torra i Bou JE, Rueda Lopez J, Blanco Blanco J, Torres Ballester J, Toda Lloret L. Venous ulcers. Multilayer compression system or crepe bandage? Comparative study on effectiveness, cost and impact on quality of life [Spanish]. Revista de Enfermeria 2003;26(9):59‐66. - PubMed
Van Laere 2010 {published data only}
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- Laere M. Comparative study between 2 short stretch compression systems. EWMA Conference, 26‐28 May 2010, Geneva, Switzerland. EWMA Journal 2010;10(2):149, Abstract 173.
Vowden 2001 {published data only}
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- Vowden KR, Wilkinson D, Vowden P. The K‐Four bandage system: evaluating its effectiveness on recalcitrant venous leg ulcers. Journal of Wound Care 2001;10(5):182‐4. - PubMed
Walker 1996 {published data only}
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Zamboni 2004 {published data only}
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References to studies awaiting assessment
Bertaux 2010 {published data only}
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- Bertaux E, Ettner N. A new approach to treat venous leg ulcers by compression therapy. EWMA Conference, 26‐28 May 2010, Geneva, Switzerland. EWMA Journal. 2010; Vol. 10, issue 2:40, Abstract 39.
Harrison 2011 {published data only}
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- Harrison MB. The Canadian bandaging trial: A multi‐site RCT of bandaging technologies for venous leg ulcers. The 2011 International Nursing Research Conference; 16‐18 May, 2011; Harrogate, UK. 2011.
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- Harrison MB, VanDenKerkhof EG, Hopman WM, Graham ID, Carley ME, EA Nelson for the Canadian Bandaging Group. The Canadian Bandaging Trial: evidence‐informed leg ulcer care and the effectiveness of two compression technologies. BMC Nursing 2011;10(20):available from http://www.biomedcentral.com/1472‐6955/10/20 (accessed June 2012). - PMC - PubMed
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Moffatt 2003b {published data only}
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- Moffatt CJ. A multi‐centre randomised study comparing a new innovative vari‐stretch compression bandaging system with a traditional multi‐layer compression bandage system for the management of venous leg ulcers [Abstract]. 13th Conference of the European Wound Management Association; 2003, 22‐24 May; Pisa, Italy. 2003:111.
Mosti 2010 {published data only}
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- Mosti G, Mattaliano V, Conte R, Abel M. Promotion of healing, pain relief, tolerability and quality of life: results of a prospective, controlled, randomized comparison study with two wound dressings in out‐patients with non‐infected leg ulcers. EWMA Conference, 26‐28 May 2010, Geneva, Switzerland. EWMA Journal. 2010; Vol. 10, issue 2:59, Abstract 77.
Mosti 2011 {published data only}
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- Mosti G, Crespi A, Mattaliano V. Comparison between a new, two‐component compression system with zinc paste bandages for leg ulcer healing: a prospective, multicenter, randomized, controlled trial monitoring sub‐bandage pressures. Wounds: A Compendium of Clinical Research & Practice 2011;23(5):126‐34. - PubMed
Taradaj 2011 {published data only}
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Wong 2012 {published data only}
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References to ongoing studies
Dumville 2009 {published data only}
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Matos de Abreu 2011 {published data only}
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