Impact of Compression Therapy on Cellulitis

Not Applicable

• Conditions: ower Limb Recurrent Cellulitis; Lower limb Chronic Oedema; Lower Limb Recurrent Cellulitis; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12617000412336
• Lead Sponsor: Calvary Public Hospital Bruce

Brief Summary

Research questions: 1. To determine if compression therapy prevents the recurrence of lower limb cellulitis in adults with lower limb chronic oedema and recurrent cellulitis. 2. To determine and compare the cost of an episode of cellulitis and the cost of compression therapy over 18-months from both patient and health service perspectives. Background information and results: Trial inclusion criteria included adults with chronic oedema and a history of 2 or more episodes of cellulitis in the same leg in the 2 years prior to trial referral. Participants were randomised to receive either education regarding cellulitis prevention (control group) or the same education plus compression therapy (experimental group). Participants were planned to be followed up 6-monthly for up to 3 years or until 45 episodes of cellulitis occurred. The primary outcome was time to cellulitis recurrence. At the time of a planned interim analysis, cellulitis had recurred in 6 (15%) of the experimental group participants, and 17 (40%) of the control group participants, giving a hazard ratio of 0.23 (95% CI, 0.09 to 0.59; P=0.002). During the RCT, the mean annual cost per participant was $4972 in the experimental group and $26,382 in the control group, giving a cost saving of $21,483 (95% CI, 3136–48,176) per participant.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-22
• Study Completion: 2020-12-17
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. The patients is over 18 years of age
2. The patient is identified as having chronic oedema (oedema persisting more than 3 months) in one or both legs
3. The patient has a history of 2 or more episodes of cellulitis in the past 2 years
4. The patient is able to understand their involvement in the study, as per the information sheet
5.The patient is able to give informed consent
6. The patient has a valid Medicare card
7. The patient is able to attend regular scheduled appointments

Exclusion Criteria

1. The patient is currently receiving chronic oedema management that involves compression
2. The patient declines to participate or is unable to participate for whatever reason
3. The patient is receiving end of life care
4. The patient is medically unstable
5.The patient has wounds requiring treatment that prevents use of compression garments
6. The patient is unable to wear compression (unable to don/doff garments or has a medical condition that contraindicates use of compression)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first episode of recurrent cellulitis (days) Diagnosis of cellulitis will be identified through patient report and confirmed through medical record review or from General practitioner report when deemed necessary by the clinician[Time to first episode of recurrent cellulitis (days) Diagnosis of cellulitis will be identified through participant report and confirmed through medical record review or from General practitioner report when deemed necessary by the clinician]

Secondary Outcome Measures

Name	Time	Method
Time to cellulitis-related hospital admissions; <br><br>Hospitalisation will be gained by participant self report and confirmed through medical record review or from General practitioner report.[Assessed 6 monthly for three years from initial assessment. ];Change in leg volume (% and mm). Perometer will be used to assess leg volume. Tape measure will be used as a back-up measure for leg circumferences.<br><br>[Volume assessed at initial assessment, post initial treatment and then 6monthly from initial assessment for three years. Assessment of volume post initial treatment will occur when compression garments are initially fitted. Fitting of garments may or may not be preceded by a period of compression bandaging to decrease oedema.];<br>Quality of life using LYMQOL and EQ-5D-3L questionnaires<br>[LYMQOL and eq-5d will be completed at initial assessment and then 6, 12, 24 and 36 months post intervention.]