Development and Implementation of a Clinical Pathway To Improve Venous Leg Ulcer Treatment
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Tests were carried out at the 5% significance level; the confidence interval (CI) was 95%. Statistic evaluation was performed using StatXact 5.0, double sided (a = 0.05), paired sample with Wilcoxon test, and unpaired with Mann-Whitney (N = 20 [10/10]).
The evaluation included structured interviews on how wound management was carried out before implementing the clinical pathway. Available outcomes of the center’s treatment of VU patients were used as a baseline. The clinical evaluation observation period was 12 weeks for each patient. The number of patients who withdrew from the study, of which the ulcer had not closed, were listed in full as well as any adverse incidents.
Inclusion criteria. ≥ 18 years old; men and non-pregnant women; diagnosed with a VU; able to understand the terms of the trial and willing to give consent. Inclusion was considered after any infection had resolved.
Exclusion criteria. Significant arterial disease (APBI < 0.8); other causes: rheumatoid vasculitis; DFU; malignant ulceration; oral and/or topical corticosteroids; participated in this trial previously; ulcer closed or withdrawn; unable to understand the aims and objectives of the trial and/or poor adherence; clinically infected ulcers where frequent dressing changes are required; ulcers < 4 cm² and circumferential ulcers; known allergy to latex or other contents of the trial products.
Dressing choice was made at the discretion of the clinician regarding local ulcer management. The following materials were tested in the study:
• Calcium alginate dressing, available as a wound sheet, for superficial wounds and as wound filler for deep wounds, was used for wounds with high and moderate levels of exudate.
• Foam (nonadhesive) dressing with absorbent properties was used for moderate to lightly exuding wounds and was also used as a secondary dressing.
• Collagen dressing with absorbent properties was used for stagnating ulcers and combined with a foam dressing as a secondary dressing.
A short-stretch bandaging system was used for compression and consisted of the following:
• Tubular bandage, nonelastic: the tubular bandage was applied on the skin for protection and dressing fixation. A length of 2.5 times the size of the lower limb was used—one half to cover the dressing, the second half to cover the compression bandage to prevent it from slipping.
• Foam bandage: the foam bandage is designed to act as padding underneath compression bandages. The padding bandage facilitates even pressure distribution and will not slip since its open pores interlock. It can be washed at a temperature of 40˚C–60˚C.
• Short stretch bandage.
• Fixation bandage.
• Adhesive, non-elastic fixation tape.
• Optional: foam rubber pads. The kidney-shaped pad can be applied behind the malleoli to support removal of edema.
After the ulcer was cleansed, a dressing was applied and fixed with a fixation bandage. Then the nonelastic tubular bandage was applied. Foam pads were used to provide extra pressure (eg, behind the malleoli) if required. Two foam bandages were used as padding and were applied in a spiral fashion starting at the foot and up the leg to the tibial crest. Finally, two short-stretch bandages were used in a modified Sigg technique—the 8-cm bandage was started at the toes and applied up to the calf base. The 10-cm bandage was applied up to the knee in a figure-eight fashion. The nonelastic tubular bandage was then folded over the leg and secured with a fixation bandage.
The bandages were applied and washed on average twice weekly. These cotton bandages do not have elastic fibers.
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