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Silicone film forming dressing versus standard care for the treatment of acute face burn injuries and donor site wounds.

A pilot study on post-burn healing: Optimising scar outcome through the use of a silicone-based film-forming wound dressing.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001227280
Enrollment
85
Registered
2018-07-20
Start date
2018-08-29
Completion date
2021-01-17
Last updated
2024-08-05

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 obtain high quality data on the impact of the early application of film forming silicones on burn injuries and donor sites. Objectives include time to healing, patients perceived pain and scar outcomes.

Interventions

There are two arms to this research. The first arm will study Stratamed on facial burn wounds and the second arm will study StrataXRT on donor site wounds. Stratamed and StrataXRT are different products but are both silicone based wound care products. Research Arm 1: Stratamed - a topical silicone film forming dressing that will be used in non-surgical face burn wounds. 1) A thin layer of topical silicone gel will be smeared over the entire facial burn wounds for those patients randomised to th

There are two arms to this research. The first arm will study Stratamed on facial burn wounds and the second arm will study StrataXRT on donor site wounds. Stratamed and StrataXRT are different products but are both silicone based wound care products. Research Arm 1: Stratamed - a topical silicone film forming dressing that will be used in non-surgical face burn wounds. 1) A thin layer of topical silicone gel will be smeared over the entire facial burn wounds for those patients randomised to the intervention group. For those randomised to the control group they will follow the same dressing protocol using standard care with emollient. 2) In between dressing appointments and when at home, patients will be required to wash their face wounds three times daily and reapply another thin layer of topical silicone or emollient every 2 hours. 3) Patients will need to attend dressing clinics for wound reviews within the following schedule. Day 2-5, day 5-7, day 7-10 and day 10-14. Clinics are not open on public holidays and on weekends so follow up appointments need to be made within the ranges of days as above. 4) When attending dressing appointments a nurse will assist the patient with washing their face wounds. The researcher will take pain outcome measures and arrange clinical photography of the face burn wounds. A blinded clinical nurse will assess the percentage of wound healing. If still requiring treatment, another layer of topical silicone gel or emollient will be reapplied as per the allocation group. 7) The blinded clinical nurse will assess if the face wounds are fully healed. Once healed, topical silicone or emollient will be ceased, and standard care for healed face burns will be taught by the Occupational Therapist. 8) The participants will attend clinic appointments at 6 weeks and 3 months post burn injury for routine scar assessments. At these same appointments outcome measures for scarring will be completed including clinical photography, patient POSAS questionnaire, dermalab measures (pigment and vascularity) and Vancouver Scar Scale (VSS) assessment. Research Arm 2: StrataXRT - a topical silicone film forming dressing that will be used on donor sites. In participants with two donor sites, the intervention will be randomised to the medial or lateral donor site. In participants with only one donor site will be included. These donor sites will be halved laterally and the treatment will be randomised to one side of the donor site. 1) Randomisation will occur at the point of surgery in theatre. The intervention donor site will receive a thin layer of topical silicone gel (StrataXRT) to the dressing. The StrataXRT gel will be smeared over the dressing before being applied to the intervention donor site wound. The control donor site will have the same dressing but it will not have a layer of gel applied to it. 2) The same type of dressings will be used at each dressing change until the donor site wounds are healed. This will be an Algisite and fixomull dressing and will be applied at baseline in theatre. Both both donor sites will receive the same dressing but only the intervention donor site will have the topical silicone smeared over its dressing. 3) The patients will need to attend dressing clinics for dressing changes within the following schedule. Day 2-5, day 5-7, day 7-10 and day 10-14. Attendance can only occur during week days as dressing clinics are not open weekends and public holidays. The donor site dressing will need to remain intact for 5 days, however, this can be changed earlier if the dressing has significantly leaked or if day 5 falls over a weekend or public holiday. Therefore the day of the week the donor site dressing will next be changed is determined by the day of surgery (when the donor site wound is created). 4) Donor site wounds will be changed by a nurse with the patient alert and lying down in the clinic room. The researcher will collect pain outcomes before donor site dressings are removed. The donor site wound will be the first dressing to be changed and any other burn wound or graft dressings will remain intact at this point. 5) Once the burn donor site dressing is removed and cleaned, photographs will be completed by clinical photography and the separate blinded clinical nurse wound assessor will assess the percentage of wound healing in both the intervention and control donor sites. The donor site wounds can then be re-dressed with a clean Algisite and fixomull dressing with StrataXRT applied to the dressing for the intervention donor site. The primary research investigator will liaise with and observe nursing staff to ensure that participants remain in the same allocated control or intervention group and the same dressing protocol and application is adhered to. The patient will be blinded to this process and will not be able to see the preparation of the donor site dressings and application of StrataXRT. The patient will then be asked to complete outcome measures including the pain intensity scale, and a pain questionnaire. Any other burns wounds or dressings can then be changed. 6) The patient will continue to attend appointments for donor site dressing changes and outcome measures until the blinded nurse assessor confirms the donor site wounds are healed. Once healed, StrataXRT will cease and the patients will no longer require dressings. Standard care of moisturising for healed donor sites will proceed. 7) At 6 weeks and 3 months post burn injury outcome measures for scarring will be completed at follow up clinic appointments. Scar outcome measures will be completed by blinded Occupational Therapists and include dermalab measures (pigment and vascularity) and VSS. The researcher will facilitate clinical photography, and the on-line patient POSAS will be completed by the patient.

Sponsors

Fiona Wood Foundation
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

First arm: Faces Adults 18-80 years of age Burns <15% Total Body Surface Area (TBSA) Burns not requiring surgical intervention Second Arm: Donor Sites Adults 18-80 years of age Burn < 15% TBSA Donor site > 0.5%

Exclusion criteria

First Arm: Burn > 15% TBSA Burn requiring surgical intervention Aged below 18 years or older than 80 years Diabetes Neuropathy Vascular abnormality Pre-existing dermalogical condition Pregnant women Infection Late presentations over 1/52 Second Arm: All of the above but excluding 'burns requiring surgical intervention'.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026