Compression Therapy for Acute Lower Limb Cellulitis

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

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.

Study Overview

• Status: Terminated
• Conditions: Lower Limb Cellulitis
• Intervention / Treatment: Other: Compression therapy; Diagnostic test: initial clinical assessment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Plymouth, United Kingdom
    • Derriford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Compression therapy; compression therapy	Other: Compression therapy; Compression application; Diagnostic test: initial clinical assessment; Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)
ACTIVE_COMPARATOR: Standard treatment; standard treatment	Diagnostic test: initial clinical assessment; Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2018
• Primary Completion (ACTUAL): April 4, 2019
• Study Completion (ACTUAL): April 4, 2019

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Cellulitis
• Other Study ID Numbers: 17/P/203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No