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Impact of Compression Therapy on Cellulitis

Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000412336
Acronym
ICTOC
Enrollment
84
Registered
2017-03-22
Start date
2017-06-02
Completion date
2019-01-25
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this research is to investigate the functional impact of compression therapy (to manage chronic oedema) for adults who have chronic oedema and a history of recurrent cellulitis in a lower limb or limbs who access health services within the ACT. Reducing cellulitis recurrence could decrease the burden on the healthcare system and may positively influence the quality of life (QOL) of individuals experiencing recurrent episodes of cellulitis. Whilst this study will be performed in adults receiving healthcare services in the ACT, it is hoped the results may provide insight for cellulitis management within Australia. Research Objectives For adults with a history of chronic oedema and recurrent cellulitis who are accessing healthcare services within the ACT, we plan to investigate if use of compression therapy: (1) prevents recurrence of leg cellulitis (2) prevents cellulitis-related hospital admissions; (3) reduces affected leg volume; and (4) improves quality of life (QOL). Research Hypothesis: Addition of compression therapy to manage chronic oedema will prevent recurrence of cellulitis

Interventions

Participants in the control and intervention groups will receive education regarding cellulitis prevention at an initial appointment. The initial appointment will take approximately 60-90minutes and will be conducted in individual format. Education will involve a handout (created for the study) and verbal education regarding how to maintain good skin integrity and prevent infection through good skin care (moisturising regularly, minimising trauma to skin (long pants, closed shoes, insect repelle

Participants in the control and intervention groups will receive education regarding cellulitis prevention at an initial appointment. The initial appointment will take approximately 60-90minutes and will be conducted in individual format. Education will involve a handout (created for the study) and verbal education regarding how to maintain good skin integrity and prevent infection through good skin care (moisturising regularly, minimising trauma to skin (long pants, closed shoes, insect repellent, sunscreen etc), managing minor wounds/abrasions/bites (using antiseptic creams and covering with dressings), minimising risk of tinea/fungal infections between toes (dry between toes, thongs in public pools/showers) and managing inflammatory skin conditions). The intervention group will be provided with the same education but the initial appointment will also be used to plan appropriate compression therapy, which will then be provided in subsequent additional appointments. The treatment plan will be developed by a qualified level 1 lymphoedema physiotherapist based on the participants' requirements (e.g severity of swelling, functional capacity, and ability to do/doff compression garments). Compression therapy will consist of prescription of appropriate compression garments and where indicated provision of a period of compression bandaging to minimise swelling prior to measure for and fit of compression garments). The number of appointments necessary for provision of compression therapy will vary based on patient requirements. Patients may require between 1-6 appointments per episode of care and appointments may range from 30-90 minutes. Time per appointment and number of appointments will vary based on the severity of oedema (patients with more severe oedema will require more compression bandages to reduce oedema), patient function and comorbidities, and number of legs affected). Compression garments will be selected from the current range available on the Australian market and may include ready to wear or custom made garments, including wrap systems. The initial garments provided to the patient free of charge will be from Haddenham Health Care, who have a range of ready to wear and custom made garments which are available on the Australian market. Following this, participants in both groups will be followed for up to three years at regular intervals (6 monthly) to have outcomes measures taken and to continue to receive the allocated treatment (cellulitis prevention education with or without compression therapy). Compression garments with or without bandaging will be renewed regularly (every 6-12 months). - Clinicians who providing chronic oedema management and education to prevent cellulitis will be qualified level 1 Lymphoedema physiotherapists - Participants will be seen at Calvary Public Hospital Bruce outpatient physiotherapy department Assessments will be done face to face where possible. Phone interview may be used to find out the primary outcome. QOL tools may be mailed to the participant if required. -Compliance with treatment will be monitored at regular assessments (by self report)

Sponsors

Calvary Public Hospital Bruce
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026