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

Inclusion Criteria6

  • No burns to either thigh right or left,
  • Donor site on thigh (measured to be 10cm above the patella),
  • Male or female,
  • years or older,
  • Signed informed consent,
  • From any ethnic group (may be separated out on data analysis),

Exclusion Criteria7

  • Burns to left, right or both thighs
  • Donor site on other anatomical location other than the thigh,
  • Psychiatric history documented in the medical chart which could cause variable (self harm) of outcome,
  • Arterial disease / compromise as documented in the chart,
  • Have a dermatological condition in the region where the donor site needs to be taken which may affect the result,
  • Allergy to ultrasound gel,
  • Refused consent.

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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