The efficacy of four-layer compression bandaging, seen as the gold standard treatment for venous leg ulcers, was compared with that of two-layer compression stockings
Background: Four-layer bandaging is the standard treatment for venous leg ulcers but is bulky and can restrict mobility. Two-layer compression stockings have recently been marketed but their clinical and cost effectiveness were unknown.
Aim To compare the clinical and cost effectiveness of four-layer bandaging with two-layer compression stockings.
Method: In a pragmatic, open, randomised controlled trial 454 participants were randomly allocated two-layer compression stockings or four-layer bandages and followed for up to 12 months after healing.
Results: The median time to ulcer healing was almost identical (stockings group: 99 days, bandaging group: 98 days). More patients allocated stockings changed treatment but ulcer recurrence rates were higher in the bandaging group. Stockings cost £302 less per participant per year and had more than 95% probability of being the most cost-effective treatment.
Conclusion: Two-layer compression stockings are a viable, cost-effective alternative to four-layer bandaging but may not be suitable for all patients.
Citation: Adderley U, Stubbs N (2014) Stockings or bandages for leg-ulcer compression? Nursing Times; 110: 15, 19-20.
Authors: Una Adderley is lecturer in community nursing, University of Leeds; Nikki Stubbs is clinical lead, Wound Prevention and Management Service, Leeds Community Healthcare Trust; both are members of the VenUS IV team.
- This article has been double-blind peer reviewed
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Venous leg ulcers (VLUs) are chronic open wounds caused by poor venous return (venous insufficiency). They often recur and take months or years to heal (Valencia et al, 2001), can be painful, malodorous, prone to infection and impair mobility and quality of life (Hickie et al, 1998).
There is good evidence to support using multicomponent systems that deliver high compression (defined as 40mmHg of compression at the ankle) to promote VLU healing (O’Meara et al, 2012). Various multicomponent bandaging systems are available in the UK, but four-layer bandaging is considered the gold standard (O’Meara et al, 2012; Iglesias et al, 2004). However, its bulk can cause discomfort, problems with footwear and reduced ankle and leg mobility (Adderley and Thompson, 2007); it also requires skill to apply correctly.
In recent years two-layer compression stockings have been marketed to treat VLUs. These consist of an under- and overstocking that, together, deliver graduated compression with ankle compression of 40mmHg. Less bulky than bandages they may be more comfortable and make it easier to wear shoes. Nurses do not need specialist skills to apply them and patients with the mobility and dexterity to remove/reapply their own may need less nursing input.
There has been limited research comparing compression stockings with four-layer compression bandaging to promote ulcer healing (Finlayson et al, 2012); other studies compared stockings with short-stretch bandages (Taradaj et al, 2009; Mariani et al, 2008; Junger et al, 2004; Polignano et al, 2004). The VenUS study, therefore, aimed to compare the clinical and cost effectiveness of two-layer compression stockings with the four-layer bandage for healing VLUs. Ulcer recurrence was also assessed because compression stockings are recommended after healing to prevent recurrence (Scottish Intercollegiate Guidelines Network, 2010). We hypothesised that participants allocated stockings might be more likely to wear them after healing and therefore have less recurrence than those allocated bandaging.
centre, two-group randomised controlled trial. We recruited patients with VLUs from community and tissue viability teams/services, GP practices, community and outpatient leg-ulcer clinics, and wound clinics from 34 centres in England and Northern Ireland. Box 1 lists inclusion and exclusion criteria.
Box 1. Participant selection
- Diagnosed with ≥1 venous leg ulcer
- At least 18 years old
- Ankle brachial pressure index of ≥0.8
- Able to tolerate high compression
- Exudate levels too great for stockings
- Allergy to trial product(s)
- Gross leg oedema or inability to receive high compression (nurses’ clinical judgment or local guidelines)
We randomly allocated eligible patients two-layer compression stockings or four-layer compression bandaging and, as ulcer size and duration are known healing predictors, stratified them by ulcer duration (<6 or >6 months) and area (<5 or >5cm). We could not blind patients or nurses to treatment.
The trial specified using bandaging systems aiming to deliver 40mmHg of compression at the ankle; stockings were eligible if they were two-layer treatment systems that, with both layers worn together, aimed to deliver 35-44mmHg. Participants received their allocated treatment from their usual nurse in their usual setting at intervals decided by their nurse. This continued until their ulcer healed, they could not continue with the allocated treatment and changed to a different treatment, they were lost to follow-up or died.
Healing was defined as complete epithelial cover with no scab. When nurses judged them healed, ulcers were photographed weekly for four weeks; the photographs were independently assessed for healing by two assessors blinded to treatment group. We followed up for 12 months all those who healed, except those recruited in the final year, who were followed for 4-12 months.
Nurses recorded when and why participants changed from their allocated treatment to a non-trial one; after healing they assessed ulcer recurrence every month.
To analyse cost effectiveness, we collected data at baseline and quarterly using participants’ self-completed EQ5D health outcome questionnaires and reports of consultations with NHS health professionals.
In total, we recruited 457 participants and allocated 227 to bandaging (B) and 230 to stockings. We excluded three after randomisation so analysed data from 454 participants (B: n=224, S: n=230).
There was no difference in median time to healing between bandaging (98 days) and stockings (99 days) groups; the proportion of ulcers healed was also similar (B: 70%, S: 71%). More participants changed treatment from stockings (38%) than bandaging (28%), the most common reason cited being discomfort. Of those who experienced ulcer recurrence, more were in the bandaging group (23%) than the stockings group (14%). Average costs were about £300 per participant per year lower for the stockings group, mainly because these patients required fewer nursing consultations; this group also reported slightly higher average quality-adjusted life year scores.
Our findings suggest hosiery has a 95% probability of being the most cost-effective treatment.
There was no difference in healing rates but as stockings are less bulky and were more compatible with shoes, we were surprised more patients allocated stockings changed treatment. This suggests stockings may be less comfortable than bandaging.
People with a history of VLUs may be unwilling to continue using compression stockings after healing (Raju et al, 2007; Jull et al, 2004); this may be related to a belief that wearing compression stockings to prevent VLU recurrence is not worthwhile (Jull et al, 2004). Before the study, we hypothesised that patients who got used to wearing stockings for ulcer healing would be more likely to wear them to prevent recurrence. Information on treatments used after healing was not recorded but VLU recurrence was less in those allocated stockings.
Little is known about how compression stockings are used to treat open VLUs in the UK and only 6.5% of our sample had been treated with them before joining the trial; 49% had been treated with compression bandaging. If this reflects UK practice, greater use of stockings to treat VLUs should lead to substantial cost savings.
Although two-layer compression stockings are not suitable for all patients, our results suggest they are an effective alternative to four-layer bandaging to heal VLUs. Such stockings also appear to reduce recurrence rates and are more cost effective than four-layer bandaging.
- Venous leg ulceration is a common and distressing long-term condition
- High compression is an effective treatment but bandages are bulky, require skilled application and can cause footwear and mobility problems
- Two-layer compression stockings are an effective alternative to four-layer bandaging
- On average, two-layer compression stockings are more cost effective than four-layer bandages
- Two-layer compression stockings are not suitable for all patients with venous leg ulcers
- This article is a summary of: Ashby et al (2013) Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. The Lancet, dx.doi.org/10.1016/S0140-6736(13)62368-5
- The project was funded by the National Institute for Health Research’s Health Technology Assessment Programme (project number 07/60/26) and will be published in full in Health Technology Assessment. The views and opinions expressed are those of the authors and do not reflect those of the HTA programme, NIHR, NHS or Department of Health.
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