ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000412336

Ethics application status

Approved

Date submitted

16/02/2017

Date registered

22/03/2017

Date last updated

17/10/2022

Date data sharing statement initially provided

28/05/2019

Date results information initially provided

25/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Impact of Compression Therapy on Cellulitis

Scientific title

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

ICTOC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lower Limb Recurrent Cellulitis

Lower limb Chronic Oedema

Condition category

Condition code

Infection

Studies of infection and infectious agents

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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)

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Participants in the control group will receive only education (regarding the benefits of skin care and how to prevent cellulitis through prevention of tinea/fungal infections between toes) compared to the intervention group who will receive both education and compression.

Note: For patients in the control group, once an episode of cellulitis has occurred, they will cross-over into the intervention group to receive compression therapy.

Control group

Active

Outcomes

Primary outcome [1]

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

Timepoint [1]

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 [1]

Time to cellulitis-related hospital admissions;

Hospitalisation will be gained by participant self report and confirmed through medical record review or from General practitioner report.

Timepoint [1]

Assessed 6 monthly for three years from initial assessment.

Secondary outcome [2]

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.

Timepoint [2]

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.

Secondary outcome [3]

Quality of life using LYMQOL and EQ-5D-3L questionnaires

Timepoint [3]

LYMQOL and eq-5d will be completed at initial assessment and then 6, 12, 24 and 36 months post intervention.

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation using a randomisation table created by
computer software (i.e. computerised sequence generation)

As prophylactic antibiotics may strongly influence recurrence of cellulitis (Morton & Swartz, 2004), randomisation of participants will be stratified by prophylactic antibiotic use

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

For patients in the control group, once an episode of cellulitis has occurred, they will cross-over into the intervention group to receive compression therapy. Follow up will continue according to the original specified plan (6 monthly from initial assessment)

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size and duration of follow up
The sample size has been calculated for the primary objective of detecting a difference in time to cellulitis recurrence between the control and intervention groups. The sample size estimation is based upon the assumptions that the 3-year cellulitis recurrence rate in control participants is approximately 47% and compression therapy will reduce the 3-year incidence of recurrent cellulitis by 50%.. Assuming that events occur at a constant rate, these assumptions correspond to a hazard ratio of 0.42. The eligibility criteria of two or more episodes of cellulitis in the same leg in the past 2 years has been used so that the trial cohort have an increased likelihood of cellulitis reoccurring during the follow up period.

It is assumed that patients will be recruited over a 2.5-year period, and the total study duration will be 3.5 years. Length of participant follow up will vary based on time of enrolment. Using a sequential design software package gsDesign in R29, in order to detect a hazard ratio of 0.42 with 80% power and 2.5% (1-sided) type 1 error, a total of 45 cellulitis recurrences are needed. Under the present recruitment and recurrence assumptions, we plan to recruit 162 participants (81 per arm).

An interim analysis will be performed by a Data Monitoring Committee after 23 episodes of cellulitis. A log rank test will be used to assess group differences. If a nominal (1 sided) significance level of p=0.003 is detected, indicating a strong clinical effect, the study will be ceased. If the Data Monitoring Committee recommends that the study continue to 45 episodes of cellulitis, the final analysis will use a log rank test with (1-sided) significance level p=0.0238. These efficacy bounds were derived using a Hwang-Shih-DeCani spending function with gamma = -4 to preserve an overall Type I error rate of 5%.

Proposed methods for data analysis
For the main outcome measure of ‘time to first episode of recurrent cellulitis’ and the secondary outcome of 'time to cellulitis-related hospital admission', survival analysis will be undertaken. Kaplan-Meier plots will be used to visualise patterns of time to first cellulitis recurrence between the groups, with a log rank test being used to determine if there is a statistically significant difference between the groups. Cox proportional hazards regression may also be used to adjust for important risk factors. Right censoring will be used for participants who are lost to follow up. Intention to treat analysis will be used, with all enrolled participants being assessed according to their randomisation, regardless of protocol adherence.

For the secondary outcomes of percent change in limb volume and QOL, measures will be taken at multiple time points. Therefore, groups will be compared using a linear mixed model or using a repeated measures analysis. There will be no adjustment for multiplicity.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

After the interim analysis in March this year, the trial met the specified stopping criteria and therefore recruitment was ceased and all participants in the control group were provided with compression.

Date of first participant enrolment

Anticipated

1/04/2017

Actual

2/06/2017

Date of last participant enrolment

Anticipated

31/12/2019

Actual

25/01/2019

Date of last data collection

Anticipated

31/12/2022

Actual

17/12/2020

Sample size

Target

162

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

Calvary Public Hospital ACT - Bruce

Recruitment hospital [2]

The Canberra Hospital - Garran

Recruitment postcode(s) [1]

2617 - Bruce

Recruitment postcode(s) [2]

2605 - Garran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Calvary Public Hopsital Bruce

Address [1]

Calvary Public Hospital Bruce,
Haydon Drive,
Bruce
ACT 2617

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Haddenham Healthcare

Address [2]

30/170 Forster Rd,
Mount Waverley
VIC 3149

Country [2]

Australia

Primary sponsor type

Hospital

Name

Calvary Public Hospital Bruce

Address

Calvary Public Hospital Bruce,
Haydon Drive,
Bruce
ACT 2617

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Calvary Public Hospital Human Research Ethics Committee

Ethics committee address [1]

Calvary Public Hospital
Haydon Drive,
Bruce
ACT 2617

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/11/2016

Approval date [1]

17/01/2017

Ethics approval number [1]

Ethics committee name [2]

ACT Health Human Research Ethics Committee

Ethics committee address [2]

PO Box 11
Woden
ACT 2606

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

13/04/2017

Approval date [2]

18/05/2017

Ethics approval number [2]

ETH.4.17.092

Summary

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

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Elizabeth Webb

Address

Calvary Public Hospital
Haydon Drive
Bruce
ACT 2617

Country

Australia

Phone

+61 412 959 294 and +61 2 6201 6190

Fax

[email protected]

Contact person for public queries

Name

Ms Elizabeth Webb

Address

Calvary Public Hospital
Haydon Drive
Bruce
ACT 2617

Country

Australia

Phone

+61 412 959 294 and +61 2 6201 6190

Fax

[email protected]

Contact person for scientific queries

Name

Ms Elizabeth Webb

Address

Calvary Public Hospital
Haydon Drive
Bruce
ACT 2617

Country

Australia

Phone

+61 412 959 294 and +61 2 6201 6190

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Webb E, Neeman T, Bowden FJ, Gaida J, Mumford V, B... [More Details]
Study results article	Yes	2019 Webb E, Neeman T, Gaida J, Bowden FJ, Mumfor... [More Details]
Study results article	Yes	Webb E, Bissett B, Neeman T, Bowden F, Preston E, ... [More Details]
Plain language summary	No	Research questions: 1. To determine if compression... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: A randomised controlled trial protocol.	2019	https://dx.doi.org/10.1136/bmjopen-2019-029225
Embase	Compression therapy to prevent recurrent cellulitis of the leg.	2020	https://dx.doi.org/10.1056/NEJMoa1917197

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically