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Moderate and high elastic compression hosiery did not differ statistically for recurrence of venous ulceration at 5 years
  1. Jo Gibson, RGN, MSc
  1. Southport and Ormskirk NHS Hospital Trust,
 Southport, UK

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 Q What is the relative effectiveness of high compression (class 3) and moderate compression (class 2) hosiery for prevention of venous ulcer recurrence?

    METHODS

    Embedded ImageDesign:

    randomised controlled trial.

    Embedded ImageAllocation:

    concealed (although concealment was potentially compromised in the allocation of 2 patients).

    Embedded ImageBlinding:

    blinded {data analysts}.*

    Embedded ImageFollow up period:

    5 years.

    Embedded ImageSetting:

    leg ulcer clinics at 2 hospitals in Scotland, UK.

    Embedded ImagePatients:

    300 patients (mean age 64 y, 58% women) with newly healed venous leg ulcers defined by clinical, Doppler, or duplex criteria. Exclusion criteria were diabetes, an ankle-brachial pressure index <0.8, or seropositive rheumatoid arthritis.

    Embedded ImageIntervention:

    151 patients were allocated to moderate compression (18–24 mm Hg at the ankle) with class 2 graduated knee or thigh length compression hosiery (Jobst, BSN Medical, Hull or Medi, Medi, Hereford, UK), and 149 patients were allocated to high compression (25–35 mm Hg) with class 3 compression hosiery. Patient follow up visits every 4 months comprised examination of the leg, continued education on skin care, and remeasurement and supply of hosiery. Patients were also given a hotline telephone number to contact a leg ulcer nurse if problems arose.

    Embedded ImageOutcomes:

    recurrence of venous ulceration (skin break in the same leg that failed to heal after 6 wks of high compression bandaging and simple low adherent dressings). Based on an ulcer recurrence rate of 40%, 150 patients per group were required to detect a 15% difference between groups (80% power) at α = 5% level of significance. Secondary outcomes included all skin breaks and patient compliance.

    Embedded ImagePatient follow up:

    83% (intention to treat analysis).

    MAIN RESULTS

    Over 5 years, 107 patients (36%) had ulcer recurrence, and 126 patients (42%) reported a skin break. Moderate and high compression hosiery did not differ for recurrence of venous ulceration (39% v 32%, Cox proportional hazards model, p = 0.14) or all skin breaks (p = 0.13). 106 patients did not comply with their assigned compression hosiery: non-compliance was higher in the high compression hosiery group than the moderate compression group (42% v 28%, {p = 0.012}†).

    CONCLUSION

    Moderate and high compression hosiery did not differ statistically for recurrence of venous ulceration at 5 years.

    *Information provided by author.

    †Calculated from data in article.

    Commentary

    Preventing the recurrence of venous ulcers after initial healing is clinically and economically important.1 Effective measures include surgery for superficial venous reflux2 and class 3 compression hosiery.3 Recent guidelines suggest that class 3, rather than class 2, compression is the treatment of choice, but there is little evidence to support this practice.4

    The study by Nelson et al found no significant effect in favour of class 3 compression hosiery (over class 2 compression) for reduced incidence of ulcer recurrence over a 5 year follow up. Non-compliance was high, but even the subgroup of patients who were able to tolerate class 3 hosiery did not have a significantly different recurrence rate from others in the class 2 or class 3 groups.

    Not all patients in the trial had venous Duplex scanning because of a lack of resources. Future trials should consider scanning of all patients if relations between deep or superficial venous incompetence, class of compression, and recurrence rates are to be investigated. The clinical strategy of starting with class 3 stockings and switching to class 2 if not tolerated, or vice versa, could also be evaluated further.

    The most effective compression stocking is the one the patient will actually tolerate. Therefore, poorer compliance with class 3 hosiery may outweigh any additional benefit it provides over class 2 hosiery. Community services should therefore determine what they consider to be the most effective strategies to get patients into any class of compression hosiery after venous ulcer healing. Such strategies should include patient education and support services to improve compliance and reduce recurrence rates.

    View Abstract

    Footnotes

    • For correspondence: Dr E A Nelson, University of Leeds, Leeds, UK. e.a.nelson{at}leeds.ac.uk

    • Source of funding: Chief Scientist Office, Scotland.

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