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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

Suprathel versus Hypafix in the management of split-thickness donor site wounds in the elderly: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49845777
Enrollment
40
Registered
2024-04-15
Start date
2022-01-26
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Split thickness donor site wounds Surgery

Interventions

Eligible patients will be randomized (blinded using a sealed envelope system) to receive either Suprathel or the current dressing mainly used sterilized Hypafix to their graft site wound as part of th

Sponsors

Mid and South Essex NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 65 to 100 years of age 2. Undergoing less than 2% Total Body Surface Area (TBSA) split skin grafting 3. Able to provide informed consent to the study

Exclusion criteria

Exclusion criteria: 1. Patients without the above age range 2. Any allergy to either of the dressings used in the study 3. Patients with any medical condition such as immunosuppression, poorly controlled diabetes or peripheral vascular disease predisposing to altered wound healing

Design outcomes

Primary

MeasureTime frame
Time to donor site 95% healed (in days), by visual assessment of total surface area re-epithelialised, confirmed and verified with photographs

Secondary

MeasureTime frame
1. Pain and itch measured using visual analogue scale at 1 week, 2 weeks, and weekly until healed 2. Scar outcome, including colour, relief, vascularity, pliability, and thickness, assessed by patient and observer using Patient and Observer Scar Assessment Scale (POSAS) v2 at the time of healing and week 13

Countries

England, United Kingdom

Contacts

Public ContactDavid Cussons
david.cussons@nhs.net+44 (0)1245 362000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026