Adding topical pale sulfonated shale oil to compression therapy and moist wound care reduced venous leg ulcer size but had no effect on complete wound healing after 20 weeks
Q Does topical application of pale sulfonated shale oil (PSSO) in addition to usual care with compression therapy and standard moist wound care improve healing of venous leg ulcers?
METHODS
Design:
randomised controlled trial.
Allocation:
{concealed}.*
Blinding:
blinded {patients, healthcare providers, data collectors, and outcome assessors}.*
Follow up period:
to the end of the 20 week treatment period.
Setting:
13 outpatient wound clinics in Germany and Slovakia.
Patients:
119 patients >18 years of age (mean age 69 y, 67% women) who had leg ulcers ⩾3 cm2 caused by chronic venous insufficiency. Exclusion criteria were severe cardiac, respiratory, gastrointestinal, liver, or renal disease; malignancy; signs of wound infection; and pregnancy or lactation.
Intervention:
10% Leukichtan PSSO gel (Ichthyol-Gesellschaft, Germany) (n = 62) or placebo gel (n = 57). Both gels were applied daily as a 2–2.5 mm thick layer directly onto the wound surface and covered by a non-adherent gauze dressing (Jelonet, Smith & Nephew Medical, Germany). Compression therapy was applied …
