BACKGROUND:Ecchymosis, oedema, haematoma and pain after SMAS-based facelift surgery are all the direct result of the physical trauma of surgery and subsequent inflammatory response. Hilotherapy is a novel form of cryotherapy that purports to minimise these events through single-use face masks circulating cooled, sterile water. This study was performed to assess the validity of Hilotherapy in this population of patients. METHODS:Over 14 weeks fifty consecutive patients were randomised to post-operative facial cooling with Hilotherapy or management with standard dressings alone, while fifteen subsequent, consecutive patients were randomised to cooling of one side of the face but not the other. Assessment of ecchymosis, oedema, haematoma and pain was performed independently by clinical staff and patients. The second analysis was undertaken to better delineate pain relief using each individual patient as their own control. RESULTS: The Hilotherapy mask produced a statistically significant difference in facial skin temperature (p = 0.01). In the second limb of the study patients reported a statistically significant increase in facial swelling 6-8 days post surgery in the half of the face that was treated with the mask (p = 0.05) but there was no significant difference in ecchymosis, haematoma and pain between comparison groups (p > 0.10) in either limb of the study. Subjectively the majority of patients found the cooling masks to be comforting. CONCLUSION: In this randomised, controlled trial the Hilotherapy mask produced significant facial skin cooling after SMAS-based facelift surgery at the expense of a statistically significant increase in patient reported post-operative swelling. No objective benefits were derived in terms of reducing ecchymosis, haematoma or pain.
RCT Entities:
BACKGROUND:Ecchymosis, oedema, haematoma and pain after SMAS-based facelift surgery are all the direct result of the physical trauma of surgery and subsequent inflammatory response. Hilotherapy is a novel form of cryotherapy that purports to minimise these events through single-use face masks circulating cooled, sterile water. This study was performed to assess the validity of Hilotherapy in this population of patients. METHODS: Over 14 weeks fifty consecutive patients were randomised to post-operative facial cooling with Hilotherapy or management with standard dressings alone, while fifteen subsequent, consecutive patients were randomised to cooling of one side of the face but not the other. Assessment of ecchymosis, oedema, haematoma and pain was performed independently by clinical staff and patients. The second analysis was undertaken to better delineate pain relief using each individual patient as their own control. RESULTS: The Hilotherapy mask produced a statistically significant difference in facial skin temperature (p = 0.01). In the second limb of the study patients reported a statistically significant increase in facial swelling 6-8 days post surgery in the half of the face that was treated with the mask (p = 0.05) but there was no significant difference in ecchymosis, haematoma and pain between comparison groups (p > 0.10) in either limb of the study. Subjectively the majority of patients found the cooling masks to be comforting. CONCLUSION: In this randomised, controlled trial the Hilotherapy mask produced significant facial skin cooling after SMAS-based facelift surgery at the expense of a statistically significant increase in patient reported post-operative swelling. No objective benefits were derived in terms of reducing ecchymosis, haematoma or pain.