PRESENT - Prophylaxis of Recurrent Erysipelas in lower limbs: compreSsion thErapy vs aNTibiotics and compression therapy. A non-inferiority, randomized, multicenter clinical trial.

Conditions

Recurrent Erysipelas in lower limbs

Brief summary

Proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by a assessor-blinded.

Detailed description

Time to the first confirmed recurrence of erysipelas., Severity of recurrence: number of nights in hospital for cellulitis., Presence of skin necrosis or ulceration., Assessment of adverse effects and serious adverse effects during the prophylaxis phase., Quality of life: Dermatology Life Quality Index and EQ-5D-5L, Adherence: number of days per week that compression was worn (using a patient book)., Assessment of oedema by circumferential measurements and using the truncated cone formula., Number of days per week that antibiotics is taken (using a patient book), Health-economic: Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (15%).

Related papers

No related papers found yet.

Interventions

DRUGPHENOXYMETHYLPENICILLIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by a assessor-blinded.	—

Secondary

Measure	Time frame
Time to the first confirmed recurrence of erysipelas., Severity of recurrence: number of nights in hospital for cellulitis., Presence of skin necrosis or ulceration., Assessment of adverse effects and serious adverse effects during the prophylaxis phase., Quality of life: Dermatology Life Quality Index and EQ-5D-5L, Adherence: number of days per week that compression was worn (using a patient book)., Assessment of oedema by circumferential measurements and using the truncated cone formula., Number of days per week that antibiotics is taken (using a patient book), Health-economic: Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (15%).	—

Measure

Time frame

Time to the first confirmed recurrence of erysipelas., Severity of recurrence: number of nights in hospital for cellulitis., Presence of skin necrosis or ulceration., Assessment of adverse effects and serious adverse effects during the prophylaxis phase., Quality of life: Dermatology Life Quality Index and EQ-5D-5L, Adherence: number of days per week that compression was worn (using a patient book)., Assessment of oedema by circumferential measurements and using the truncated cone formula., Number of days per week that antibiotics is taken (using a patient book), Health-economic: Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (15%).

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Countries

France

Outcome results

None listed