RecruitingACTRN12610000127000

Do pressure garments help burn donor sites to heal?

Interim pressure garment therapy (4–6 mmHg) and its effect on donor site healing in burn patients: a randomised controlled trial


Sponsor

Royal Brisbane and Women's Hospital

Enrollment

44 participants

Start Date

Sep 5, 2010

Study Type

Interventional

Conditions

Summary

Pressure garment therapy (PGT) is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24–40 mmHg) in these garments can support scar minimisation, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4–6 mmHg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been twofold. IPGs for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggests that IPGs also make a difference to some patient’s scar outcomes for donor sites. This study is a randomised controlled trial designed to test the effectiveness of this treatment on reducing scarring to burn donor sites. Methods/design This study is a single-centre, single (assessor)-blinded, randomised control trial in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post-operatively (on day 5). Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months.This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a potentially cost-effective scar prevention for patients with donor sites to the thigh. No known studies of this nature have been carried out to date, and there is a need for rigorous clinical evidence for low-pressure support garments for donor site scar minimisation.


Eligibility

Sex: Both males and femalesMin Age: 14 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether wearing a light pressure garment (like a compression bandage sleeve) over the area of skin that was taken (the donor site, usually on the thigh) when a skin graft is harvested for a burn helps that area heal with less scarring. Pressure garments are already used for burns scars, but their specific effect on donor sites is not well understood. You may be eligible if: - You are 14 years of age or older - You are having a skin graft with the donor site on your thigh - You do not have burns on either thigh - You have signed informed consent You may NOT be eligible if: - You have burns on either thigh - Your donor skin is being taken from a location other than the thigh - You have a psychiatric history that could affect the outcome (such as self-harm) - You have arterial disease affecting blood flow - You have a skin condition in the donor site area - You are allergic to ultrasound gel Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Elastic bikepants will be fitted at day 5 following surgery, and replace every 2 weeks for a period of 3 months. The pressure in each pair of bikepants will be measured at these times.

Elastic bikepants will be fitted at day 5 following surgery, and replace every 2 weeks for a period of 3 months. The pressure in each pair of bikepants will be measured at these times.


Locations(1)

QLD, Australia

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ACTRN12610000127000