Compression Therapy for Acute Lower Limb Cellulitis

Study Overview
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Brief Summary
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Initiating early compression therapy in the treatment of lower limb cellulitis for adults admitted to the acute hospital to improve patient outcomes - a pilot study Cellulitis is a skin infection that results in oedema (additional fluid within tissues), erythema (redness) and variable levels of skin damage. Patients generally present with malaise, pain and if a lower limb is affected they have difficulty mobilising and weight bearing. Patients within this organisation are often referred to the tissue viability service only after significant skin damage has occurred (even thought they are receiving appropriate antibiotic therapy). At this point they will be offered an established plan of care that includes compression therapy if it can be tolerated however at present less than 50% of those being admitted are referred. Despite compression therapy being well proven in oedema management there is no data available to support or reject the early application in lower limb cellulitis. There is also a lack of information about the impact of early intervention in quality of life for patients in this specific group. This study has been developed in order to determine the feasibility of being able to undertake a wider trial which would evaluate the outcomes of patients with acute lower limb cellulitis treated with compression therapy versus standard care. The objectives of the study would be to test the procedures and data collection tools being considered for use in a wider study. This would include collection of quality outcome questionnaires, limb circumference measurements and photography as well as recruitment of participants, the follow up processes and participant attrition. Secondary objectives would be linked to quality of life outcome measures and would determine oedema reduction (and its impact on quality of life), the average number of beddays compared to a historical cohort and to determine recurrence within the study period.

Detailed Description
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Cellulitis is a skin infection that results in oedema (additional fluid within tissues), erythema (redness) and variable levels of skin damage. Patients generally present with malaise, pain and if a lower limb is affected they have difficulty mobilising and weight bearing. Patients within this organisation are often referred to the tissue viability service only after significant skin damage has occurred (even thought they are receiving appropriate antibiotic therapy). At this point they will be offered an established plan of care that includes compression therapy if it can be tolerated however at present less than 50% of those being admitted are referred. Despite compression therapy being well proven in oedema management there is no data available to support or reject the early application in lower limb cellulitis. There is also a lack of information about the impact of early intervention in quality of life for patients in this specific group. This study has been developed in order to determine the feasibility of being able to undertake a wider trial which would evaluate the outcomes of patients with acute lower limb cellulitis treated with compression therapy versus standard care. The objectives of the study would be to test the procedures and data collection tools being considered for use in a wider study. This would include collection of quality outcome questionnaires, limb circumference measurements and photography as well as recruitment of participants, the follow up processes and participant attrition. Secondary objectives would be linked to quality of life outcome measures and would determine oedema reduction (and its impact on quality of life), the average number of beddays compared to a historical cohort and to determine recurrence within the study period.

Official Title
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Initiating Early Compression Therapy in the Treatment of Lower Limb Cellulitis for Adults Admitted to the Acute Hospital to Improve Patient outcomes-a Feasibility Study

Conditions
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Lower Limb Cellulitis

Intervention / Treatment
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* Other: Compression therapy
* Diagnostic Test: initial clinical assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical features of acute class 2-4 cellulitis of the lower leg They have an Ankle Brachial Pressure Index between ≥0.8 and ≤1.3 or Toe Brachial Pressure Index ≥ 0.7 for treatment with full compression therapy They have a Laboratory Risk Indicator for Necrotising Fasciitis (LRINEC) score of less than 6 and no clinical signs of necrotising fasciitis They are able to tolerate compression therapy, keeping the bandages in place above the level of visible cellulitis for the treatment period 18 years or older capable of giving informed consent They are admitted to the study setting Exclusion Criteria: Clinical signs or symptoms of peripheral arterial disease Unable to give informed consent Unable/unwilling to wear compression bandages for study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: compression therapy vs standard therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compression therapy<br>compression therapy | Other: Compression therapy<br>* Compression application<br>Diagnostic Test: initial clinical assessment<br>* Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)<br>|
| Active Comparator: Standard treatment<br>standard treatment | Diagnostic Test: initial clinical assessment<br>* Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruiting 40 participants within 6 months | Recruitment of 40 participants within 6 months, who meet the eligibility criteria | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine changes in quality of life outcome measures using EQ-5D-5L questionnaires. | Quality of life outcome measures analysing EQ-5D-5L questionnaires. | 6 months | 
| Determine oedema reduction. | Measuring limb circumference sequentially to estimate limb volume at each bandage change. Measurement in centimetres. | 6 months | 
| Determine average number of bed days. | Comparing historical cohort of 40 patients admitted for treatment from April 2017 | 6 months | 
| To determine cellulitis recurrence in patients within the study period. | To record cellulitis recurrence in the 40 patients admitted for treatment from April. | 6 months |