Open-label study to evaluate the healing rate and safety of the Profore Extra Four-Layer Bandage System in patients with venous leg ulceration.

BACKGROUND

Venous ulcers are increasing in prevalence, especially since these are observed more frequently in the elderly, and the number of individuals in this age group is becoming a larger portion of the population.

OBJECTIVE

To determine the healing rate and safety of the Profore Extra Four-Layer Bandage System in the management of venous leg ulcers.

METHODS

In an open-label study, patients aged 18 years or older with venous leg ulcers were treated with a high compression four-layer bandage system in which a hydrocellular dressing was placed in contact with the wound. The combination is designated the "Profore Extra Four-Layer Bandage System." Follow-up visits took place weekly unless there was heavy exudation from the ulcer or if there was marked edema of the leg at the start of the study requiring reapplication of the bandage system.

RESULTS

Fifteen patients were entered into the study (men 8, women 7, mean age 66 years, mean duration of ulcers 1.3 years). Thirteen of the 15 patients completed the study, with two withdrawals. In one patient who withdrew, the ulcer became infected and required treatment with antibiotics. The other termination from the study occurred for reasons unrelated to treatment. The ulcer in this patient healed in 7 weeks. Ten of the 13 patients (77%) who completed the study, and 10 (67%) of 15, who had enrolled experienced complete (100%) healing. Healing of > 80% of the ulcers occurred in 11 of 13 patients (85%) who completed the study and in 12 (80%) of 15 enrolled patients. No patient experienced a study-related adverse event. One patient developed contact dermatitis and was later found to have stasis dermatitis. It is unclear whether the initial event was contact or stasis dermatitis.

CONCLUSION

In this open-label study, a high compression system, using the Profore Extra Four-Layer Bandage with a hydrocellular dressing in contact with the wound, was found to be effective and safe for the treatment of venous leg ulcers.