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Monday, April 23, 2012




Wound Bandaging and Dressing

Compression Treatment of Venous Leg Ulcers

The goal of wound care is to provide an appropriate environment for healing.  An important aspect of the healing environment is bandaging and dressing the respective wound.    Bandaging and dressing of a wound serves many purposes which are:  helps to debride, provides an optimal moist environment, promotes granulation and epithelialization, and protects from infection.  Because protocols for wound care dressing are highly variable and dependent upon which type of afflicting wound it is, the purpose of this blog will be to focus on compression bandaging in regards to venous leg ulcers.  Currently compression is the standard of care for treatment of venous leg ulcers.  Below are articles that discuss the effectiveness in general as well as effectiveness of different types of compression bandaging.

Supporting Articles

A systematic review and meta-analysis of randomized controlled trials calls compression treatment a “first line treatment” for venous ulcers. This “first line treatment” can be applied as a four layer bandage device or a short stretch bandage, and both are considered high compression (ankle pressure at 35-40 mm Hg). The bandage selection depends on geographic location (trends) and health care worker preference. Five trials were analyzed that compared these two methods. Both methods were shown to improve venous ulcer healing significantly, although wounds with four layer compression treatments healed on average 30% faster, regardless of prognostic profiles. There were several factors that were predictive of healing time which included: larger area, chronic ulceration, and previous episodes of ulceration. In addition, this review’s positivity for four layer bandage is of benefit for our patient because it is also more cost effective for the patient (according to costs in the UK and includes nurse and doctor visits). While both methods are successful, and if given the choice to optimize healing time and costs, one should choose four layer compressions (O'Meara et al. 2009).

Venous leg ulcers are treated with many different bandaging systems and various studies have found that the compression bandages should have sub bandage pressure values ranging from 35 to 45 mmHg to achieve the best healing results. A randomized study by Milic et al in 2009 split their subjects into three group: 42 patients were treated using an open-toed, elastic, class III compression device knitted in tubular form, 46 patients were treated with the multi-component bandaging system comprised of Tubulcus and one elastic bandage) and 43 patients were treated with the multi-component bandaging system comprised of Tubulcus and two elastic bandages. The healing rate during the 26-week treatment period was 25% in the first group, 67.4% in the second group, and 74.4% in the third group. The authors attributed the success of compression treatment in the first group was associated with the small ulcer surface (<5 cm (2)) and smaller calf circumference (CC; <38 cm), but they had better compliance than the other groups, but the healing rate was higher in these groups, especially in patients with large ulcers and a large CC (>43 cm). In conclusion, the authors found that multi- component compression systems were superior in healing rates compared to single- component compression system, but that the compression system should be individualized according to the patient's leg and calf circumference (CC). They conclude that the sub bandage pressure can be calculated with the formula CC/CC + 2

Another group of researchers wanted to explore the cost effectiveness of compression treatment following a sustained venous leg ulcer. Specifically, they hoped to discover and determine a system of compression that was more effective than the others. The systematic review by Fletcher, Cullum et al. began through a search of numerous electronic databases. They wanted to find randomized controlled trials that explored the rate of healing of venous ulcers. The group included 24 trials in the review. It was found that general compression does increase healing rates. In addition, through the exploration of the articles, they concluded high compression treatments were more effective than low compression. For example, delivering 3-4 layers of compression performs better than low compression systems or single-layer compression. Unfortunately, they were not able to determine clear differences in the effectiveness of the type of compression system used. It appears the evidence is lacking in the area, and further research is needed to conclude whether what system of bandaging is most effective. They discovered that due to a poor quality of research in the area, the method of bandaging that achieves the best outcome could not be concluded. Because of this, one could assume that rather than encouraging the use of a specific compression system, the one should focus on a high compression regime in general. One could further conclude that the least expensive compression, which offers the highest compression, should be used in the treatment of a venous ulcer.  (Fletcher, Cullum et al. 1997)

Opposing Articles

Although compression therapy is usually indicted for venous ulcers, there are some circumstances where compression is not proved to be an effective treatment. In a study by Milic et al., compression therapy was examined in 189 patients with venous ulcers.  Dressings included a layer of cotton gauze and cotton crepe bandaging with 50% overlap and no tension. Next, Tubulcus, a tubular compression sock was donned in one of five sizes, depending on calf circumference. The last layer was medium-stretch elastic bandage.  After the dressing, the subjects were advised to walk for 30 minutes to activate the calf muscle pump in hopes of clearing some edema. The participants were treated for 52 weeks and no one dropped out. The results of the study showed, among other things, that 12.7% of the ulcers did not heal. Two factors independently were predictors of poor healing: a fixed ankle joint and a calf: ankle circumference measure (CAC) <1.3.  A fixed ankle joint is indicative of decreased calf muscle pumping. A small CAC was speculated to either be found in patients with inactivity or with too much calf compression, leading to muscle atrophy. So, in these groups, constant compression therapy is not shown to be helpful (Milic et al., 2009).

Compression therapy is very commonly used to treat venous leg ulcers in the United States, but it is not the standard of care everywhere. A randomized control trial in Hong Kong by Wong et al compared three different treatments for venous leg ulcers in patients over 60 years old. They compared four layer bandaging, short stretch bandaging, and what they called usual care of moist wound dressing without compression and the impact on ulcer healing, area, and pain over the 24 week study. They found greater healing in the compression groups and that the healing time for the short stretch bandaging was shorter than the four layer bandaging group. Also, pain decrease was only significant for the compression groups. A previous meta-analysis by O'Meara in 2009 found that four layer bandaging had better results for healing time, so this study's significance demonstrates that there is still not a clear superior choice for compression between four layer and short stretch, but it does confirm that compression is still superior to non- compression in treating venous leg ulcers.

Although compression has been shown to be effective in the case of venous leg ulcerations, the standard bandaging system has not been shown to be more effective than any other compression. In a study completed in 2004, researchers hoped to compare the “generic four-layer bandage system” with a cohesive short-stretch system. Patients were selected based on the presence of leg ulceration and absence of common contraindications to compression (arterial insufficiency, etc.). The participants were randomized into two groups, one receiving the generic and the other receiving the cohesive short-stretch. The researchers found that by the end of 24 weeks, 71% of participants experienced complete ulcer closure. While the compression treatment was effective in each group, a between group difference was not seen in this study. Furthermore, the authors of the article cannot conclude that one bandaging system is superior or inferior to the other. It is clear that the newer, or more “up-to date” bandaging systems ultimately have the same effect as the traditional systems. One can further conclude that the most cost effective system should be implemented within the healthcare system, rather than the new kid on the block. A brand-name bandage system should not be regarded as superior until further evidence has shown a marked difference from current systems. (Franks, Moody et al. 2004)

References

Fletcher, A., N. Cullum, et al. (1997). "A systematic review of compression treatment for venous leg ulcers." BMJ 315(7108): 576-580.

Franks, P. J., M. Moody, et al. (2004). "Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration." Wound Repair and Regeneration 12(2): 157-162.

Milic, D., Zivic, S, Boddanovic, D, Karanovic, N, and Golubovic, Z. (2009). Risk factors related to the failure of venous leg ulcers to heal with compression treatment. Journal of Vascular Surgery 49(5) p.1242-1247.

O’Meara, S., Tierney, J., Cullum, N., Bland, J.M., Franks, P, Mole, T and Scriven, M. (2009). Four layer bandage compared with short stretch bandage for venous leg ulcers: systemic review and meta-analysis of randomized control trials with data from individual patients. BMJ 338:b1344.

Lauren Anderson, Katherine Martin, Brandon Smith, Kayla Ubel

2 comments:

  1. In agreement with the above articles, compression bandaging is the standard of care for the treatment of venous leg ulcers (VLUs) with high-compression bandaging proven to be more effective than low-pressure bandaging. There are many different compression systems available for treating VLUs ranging from two to four layers. Research has shown that patients who achieve full healing were the same patients who adhered to their compression therapy, which in turn is affected by the ease and comfort of the compression bandage of choice.

    The development of a new two-layer compression system (2LB), KTwo, prompted this RCT to compare the therapeutic efficacy and safety of two multilayer compression systems: KTwo and Profore (a widely-used four-layer bandage (4LB) validated in the treatment of VLUs). This study contained two parallel groups in three European countries. All participants had to meet the same inclusion/exclusion criteria. Participants were randomly allocated into two groups: 2LB and 4LB. The 4LB is considered the control group because it is the current standard of care. Each group had similar patient and wound characteristics at baseline. The mean age, mean body mass index (BMI), comorbidities, ankle brachial index (ABI), mean surface area of target ulcer, and number of ulcers between each group had no significant differences.

    Each participant was treated for 12 weeks with assessments taken every two weeks. The assessment included the endpoint, considered complete closure (100% re-epithelialisation) after the 12 weeks, and secondary endpoints (absolute wound area reduction and relative wound area reduction). Also included in each assessment was evaluation of tolerance (occurance of local adverse events) and acceptability parameters (ease of application on 4-point scale and pain on a visual analogue scale).

    The results show that the 2LB is just as effective, even more effective, than the 4LB in most areas. Complete wound closure, the relative reduction, and the absolute reduction values were consistently higher in the 2LB group in both populations. The rate of healing also favored the 2LB group. Ease of application showed the 2LB to be significantly easier to apply than the 4LB (p=0.031). There were no significant differences in local adverse effects, with 11 reported in the 2LB and 16 reported in the 4LB. Pain ratings taken with the VAS decreased at a higher rate for the 2LB group than the 4LB group, but the difference in overall pain reduction was not significant.

    Bottom Line: Both populations studied support non-inferiority of the 2LB system (KTwo) compared to the 4LB system (Profore). The 2LB was proven just as effective as the 4LB while also being considered easier to apply and better tolerated, which could make adherence to compression therapy higher and, therefore, complete wound healing more achievable.

    Reference: Lazareth, I., Moffatt, C., et al. (2012). “Efficacy of two compression systems in the management of VLUs: results of a European RCT.” Journal of Wound Care 21 (11): 553-61. PMID: 23413494.

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  2. To add on to the above summary, I chose an article that compared bandaging compression to non bandaging and compression. This randomized controlled trial compared the clinical effectiveness of compression bandaging using four-layer bandaging (4LB) or short-stretch bandaging. The 24-week study looked at venous leg ulcer patients aged greater than 60 years in a community setting. The primary parameter was time to ulcer healing. Secondary parameters were ulcer area and pain reduction comparing week 0 (start) vs week 24 (end), measuring results per group and between groups. The results of the study showed that 321 patients who received randomized treatment, 45 (14%) did not complete the 24-week study period. At 24 weeks, Kaplan-Meier analysis on healing time was statistically significant (P < .001) in favor of the compression groups. The healing time in the short stretch bandage group (9.9 [0.77]) was shorter than that of the 4LB group (10.4 [0.80]) and the usual care group (18.3 [0.86]). Pain reduction was significant (P < .001) for the compression-treated groups only.

    J Vasc Surg. 2012 May;55(5):1376-85. doi: 10.1016/j.jvs.2011.12.019. Epub 2012 Mar 17. Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers. Wong IK, Andriessen A, Lee DT, Thompson D, Wong LY, Chao DV, So WK, Abel M.


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