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Early versus Late Endermologie® Vacuum Therapy Evaluation (ELEVaTE)

Feasibility, Acceptability and Safety of Vacuum Therapy on Burn Scar outcomes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000715976
Acronym
ELEVaTE
Enrollment
20
Registered
2020-07-02
Start date
2020-10-07
Completion date
2024-03-01
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

Hypothesis That the feasibility, acceptability, cost and effectiveness of early intervention using Vacuum Therapy in the management of burns scars will be supported, in addition to an improvement in scar parameter outcomes in the early intervention cohort when compared to the later intervention cohort.

Interventions

Group 1: Early Vacuum Therapy Participants in the early group will the receive once a week vacuum therapy over an 8-week period commencing at 8 - 12 weeks post skin grafting. Vacuum Therapy treatment head, settings and duration of treatments will be decided by the treating Occupational Therapist after clinical assessment and recorded. Group 2: Late Vacuum Therapy Patients in the late group will receive once a week vacuum therapy over an 8-week period at 6 months post skin grafting. Vacuum The

Group 1: Early Vacuum Therapy Participants in the early group will the receive once a week vacuum therapy over an 8-week period commencing at 8 - 12 weeks post skin grafting. Vacuum Therapy treatment head, settings and duration of treatments will be decided by the treating Occupational Therapist after clinical assessment and recorded. Group 2: Late Vacuum Therapy Patients in the late group will receive once a week vacuum therapy over an 8-week period at 6 months post skin grafting. Vacuum Therapy treatment head, settings and duration of treatments will be decided by the treating Occupational Therapist after clinical assessment and recorded. Derma Lab Ultrasound (Cortex Technology, Denmark) Ultrasound will be used to assess scar thickness. The Derma Lab Ultrasound is a high frequency, high resolution ultrasound scanner which objectively captures and reproduces skin thickness.

Sponsors

Jamieson Trauma Institute, Royal Brisbane and Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Total Body Surface Area (TBSA) burn <15% Scar present on a limb will be eligible for Vacuum Scar to be treated is a grafted region which can be no larger than 10% TBSA

Exclusion criteria

Patients aged <18 years without parental consent TBSA >50% Pregnancy Inability/unwilling to return for follow up Inability to provide informed consent Non-English speaking Patients with underlying medical or surgical history that is a contraindication to vacuum therapy. Scars to the face, neck or genitals will not be included

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026