A prospective randomised pilot study comparing the effectiveness of Suprathel versus the standard of care dressing sterilised Hypafix for split-thickness skin graft donor sites in older patients

Plain English Summary

Background and study aims
Human skin undergoes many changes as it ages, making optimal wound healing in the older (aged over 65 years) often more challenging for the treating clinical care team. The extended time taken to heal wounds, the prolonged patient discomfort and the greater number of appointments often required before wounds heal in older patients come at an increased cost to the NHS when compared to the skin of younger patients.
The aim of this study is to evaluate the healing properties of a new type of synthetic dressing (Suprathel) compared to the current dressing used (sterilised Hypafix) to see which facilitates faster healing of skin donor sites in older patients who have undergone a split-thickness skin graft procedure at the St Andrew’s Centre for Plastic Surgery & Burns, Chelmsford. Both dressings are licenced to be used on donor sites, but older patients often have problems healing and therefore the aim is to find out which dressing heals the wounds quicker, therefore improving patient care.

Who can participate?
Patients aged 65-100 years of age attending St Andrew’s Centre for Plastic and Burns, Broomfield Hospital, Chelmsford, who are scheduled to undergo a mixed-depth skin graft

What does the study involve?
Participants undergo the skin graft procedure as part of standard-of-care treatment and following they will be randomly allocated (by a sealed envelope allocation) to either receive the Suprathel dressing or the standard-of-care Hypafix dressing to treat and heal the skin graft wound. In accordance with standard clinical practice, participants are then asked to return to the hospital to have the wound healing assessed at 1, 2 and 3 weeks after the skin graft and then fortnightly until the wound has healed. The researchers do not expect the wounds to heal any slower with this dressing than the current dressing that is used. At these appointments the researchers will take pictures of the wound sites (to give a visual documentation of how the wounds improve and scarring visible), measure the extent of healing, redress the wounds as required, assess if there is evidence of any infection to the tissue and gauge the level of pain and discomfort they are experiencing. There will be a final clinic appointment 13 weeks after the original surgery, where this process will be repeated.

What are the possible benefits and risks of participating?
The researchers do not foresee any risks from taking part in this study. Both wound dressings (Hypafix and Suprathel) have been extensively used in clinical practice. The only disadvantage of taking part could be the additional time taken (20 minutes) to undergo the informed consent process. The researchers do not foresee any personal benefit that will arise from taking part in this study. It is hoped the study will enable the researchers to further optimise wound healing in more older patients.

Where is the study run from?
St Andrew’s Centre for Plastic Surgery & Burns (UK)

When is the study starting and how long is it expected to run for?
February 2020 to July 2023

Who is funding the study?
1. Mid and South Essex NHS Foundation Trust (UK)
2. PolyMedics Innovations GmbH (Germany)

Who is the main contact?
David Cussons, david.cussons@nhs.net

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Funders

Funder type

Hospital/treatment centre

Results and Publications

Editorial Notes

31/01/2024: Study's existence confirmed by the East of England - Essex Research Ethics Committee.