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

Not Applicable

Completed

• Conditions: Burn wounds; Donor sites; Skin - Other skin conditions; Injuries and Accidents - Burns

• Registration Number: ACTRN12618001227280
• Lead Sponsor: Fiona Wood Foundation

Brief Summary

The aim of this thesis was to explore the efficacy of topical silicone film-forming dressings in comparison to standard care. Neither of the two separate studies conducted, one in donor site wounds, and the other, in SPT burns of the face and neck observed a difference in the primary study outcome of time to healing. While the studies undertaken in this thesis did not identify any changes in wound healing rates, it seems to be that silicone films may have prolonged the time to complete healing but there may be a counteracting benefit in decreased inflammation and scar pigment outcomes. The study involving Stratamed on facial burn wounds observed reduced hyperpigmentation at six weeks. This promising observation suggests a possible benefit of topical silicone introduced onto acute wounds, on scar outcomes when used as a wound dressing. Earlier scar prevention initiated in the wound healing phase has important implications for the outcomes of face and neck burns. Further research testing topical silicone as a wound dressing is needed to bolster the results of this study. Neither the donor or face/neck burn studies identified any decrease in wound pain during dressing changes using silicone-based products compared to standard practice. While this may have been due to the need to have greater statistical power, it should be noted, that pain levels and infection rates were also not reported as being worse. This study did not find any evidence of differences in healing times in superficial facial and neck burn wounds between standard care or use of Stratamed. However, film-forming silicone dressings were demonstrated to be associated with a reduction in the level of hyperpigmentation at six weeks after burn and was not associated with any adverse effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-20
• Study Completion: 2021-02-12
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

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'.

Study & Design

• Study Type: Interventional
• Study Design: Not specified