Graduated elastic compression stockings are commonly used to treat chronic venous disease (CVD),
1
particularly in patients who are not willing to undergo invasive treatment. Traditionally, compression is graduated in order to prevent a tourniquet effect, although progressive gradient compression stockings applying a higher compression over the calf area may be more effective in improving muscle pump function.2
In this issue, Buset et al.
3
embarked on the same principal behind progressive gradient compression stockings. In an open label crossover randomised controlled trial (RCT) in CVD CEAP clinical class C3–C6 patients, the authors compared an investigational stocking, which exerts no compression in the foot and heel area, to a standard stocking of the same compression class. Unaided donning success was 100% and 75% for the investigational and standard stocking, respectively (p < .001). Similarly, unaided removal (doffing) success was 100% and 66%, respectively (p < .001). There was no significant difference in leg volume reduction after a day of wearing the stockings.In order to place this RCT into perspective, it is important to acknowledge that, unlike parallel group RCTs that randomise patients to different treatments, open label crossover RCTs randomise patients to a sequence of interventions.
4
Therefore, with crossover RCTs there is a possibility of a carryover effect, which is a source of bias, because the same individual receives both interventions when comparing the two treatments.4
To overcome this problem, it has been recommended that crossover trials should include an adequate “washout” period between the end of the first intervention and the start of the second intervention, to prevent any effects from the first intervention being “carried over” to the measurement of outcome in the second intervention period.4
It seems that in the current study there was no such washout period, which may have introduced some bias. Furthermore, this study has only provided a snapshot of use of the two stocking types; longer RCTs may be worthwhile, not only to assess the outcomes used in this study, but also to assess relative efficacy using modern patient reported outcome measures5
in a broader cohort that includes CVD CEAP clinical class 2 patients.References
- Acute effects of graduated elastic compression stockings in patients with symptomatic varicose veins: a randomised double blind placebo controlled trial.Eur J Vasc Endovasc Surg. 2018; 55: 118-125
- Improvement of venous pumping function by double progressive compression stockings: higher pressure over the calf is more important than a graduated pressure profile.Eur J Vasc Endovasc Surg. 2014; 47: 545-549
- Compression stocking with 100% donning and doffing success: an open label randomised controlled trial.Eur J Vasc Endovasc Surg. 2021; 61: 137-144
- CONSORT 2010 statement: extension to randomised crossover trials.BMJ. 2019; 366: l4378
- Validation of the 3D SYM VEIN symptom assessment tool.Eur J Vasc Endovasc Surg. 2020; 60: 587-593
Article info
Publication history
Published online: November 19, 2020
Accepted:
October 22,
2020
Received:
October 13,
2020
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© 2020 European Society for Vascular Surgery. Published by Elsevier B.V.
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- Compression Stocking With 100% Donning and Doffing Success: An Open Label Randomised Controlled TrialEuropean Journal of Vascular and Endovascular SurgeryVol. 61Issue 1
- PreviewThe aim of this study was to test whether an investigational two layer stocking exerting 27–29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23–32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking.
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