A study to investigate the use of a proprietary wound dressing to reduce ankle swelling to quicken time to surgery
| ISRCTN | ISRCTN17323189 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17323189 |
| Integrated Research Application System (IRAS) | 344827 |
| Sponsor | Keele University |
| Funder | Investigator initiated and funded |
- Submission date
- 29/10/2026
- Registration date
- 29/10/2026
- Last edited
- 29/10/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The aim is to determine whether a proprietary dressing used for the treatment of injuries and known to reduce swelling can be used to ensure that patients, suffering an ankle fracture, are ready for surgery on day 7. This would enable patients to be sent home instead of kept on a ward, which could release up to 90,000 bed days per years as well as making the whole process more efficient.
Who can participate?
Patients aged 18 to 100 years presenting to A&E in the Royal Stoke University Hospital with an unstable ankle fracture
What does the study involve?
Patients will be randomly allocated into two groups. Group 1, the active group, will have the proprietary dressing in addition to any temporary fixation. Those in Group 2 are the control and have not additional dressing. Once the patient is approved for surgery their participation in the study is complete.
What are the possible benefits and risks of participating?
The potential benefit is having an ankle fracture treated earlier than normal (group 1). As the dressing is commonly used in orthopaedics, dermatology and other clinical settings there are no perceived risks from participating.
Where is the study run from?
Royal Stoke University Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2026 to May 2027
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Peter J Ogrodnik, p.ogrodnik@keele.ac.uk
Contact information
Public, Scientific, Principal investigator
Keele University
Newcastle Under Lyme
St5 5BG
United Kingdom
 ORCID ID |
0000-0003-4753-4459 |
|---|---|
| Phone | +44 (0)1782 734414 |
| p.ogrodnik@keele.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Prevention, Treatment |
| Scientific title | A randomised pilot study to determine the time to surgery when using a polymeric dressing for the alleviation of swelling prior to fixation of an ankle fracture |
| Study acronym | EAH1 |
| Study objectives | The aim of this study is to determine the whether the inclusion of a dressing, known to reduce swelling in other orthopaedic procedures, to patients prior to ankle surgery will reduce the time to operation. Research question: What is the average time to surgery for patients treated with PolyMem for an ankle fracture that is too swollen to operate on compared to those not treated with PolyMem? |
| Ethics approval(s) |
Approved 31/07/2025, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8000; edgbaston.rec@hra.nhs.uk), ref: 25/WM/0126 |
| Health condition(s) or problem(s) studied | Unstable ankle fracture |
| Intervention | Patients will be randomly divided by scratch card into one of two groups once consent is given. In the control group patients will be treated as per normal practice. In the active group patients will have their fracture additionally wrapped within a PolyMem wrap. This wrap is already in use for the treatment of limb injuries for the acceleration of swelling reduction. There will be no change to the normal treatment regime for a patient presenting an ankle fracture. All patients will have temporary fixation applied to await surgery. The choice of fixation remains with the lead surgeon: this may be a Plaster-of-Paris Back-Slab or a temporary frame. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Polymem Wrap |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/05/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Aged 18 to 100 years 2. Lower leg distal fracture requiring surgical intervention that is delayed due to oedema |
| Key exclusion criteria | 1. Under the age of 18 years 2. Over the age of 100 years 3. Not skeletally mature 4. Patients presenting poly-trauma 5. Those whose definitive fixation is not delayed due to excessive oedema 6. Those unable to give informed consent 7. Patients on regular anti-inflammatories (e.g. taken daily for the previous 7 days) 8. On medication that precludes this procedure, e.g. anti-coagulants |
| Date of first enrolment | 21/11/2026 |
| Date of final enrolment | 30/04/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Stoke-on-trent
ST4 6QG
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
29/10/2026: Study's existence confirmed by the HRA.
