Hypergranulation (HG) is well documented and a known barrier to wound healing. Accurate clinical assessment of wounds is crucial in managing HG and evaluating treatment response. Currently there is no standardised assessment for healthcare professionals to assess the severity of HG. Through a modified Delphi process involving wound care clinical experts, a prototype Hypergranulation Tool has been developed to be used in clinical practice. The Hypergranulation Tool allows assessors to grade HG within wounds as mild, moderate and severe, based on 5 separate parameters. A prospective multi-site observational study based in the United Kingdom of 80-100 adult and paediatric patients with HG within venous leg ulcers (VLU) or complex surgical wounds (CSW) will allow performance testing of the Hypergranulation Tool. Study nurses will assess wounds with the Hypergranulation Tool across 2-4 clinic visits. Data from the use of the tool will be compared with quantitative 3D analysis of the wounds, patient reported outcome and patient interview data, to help determine the validity of the Hypergranulation Tool in the clinical setting. Results from the Observational Study will inform design changes to the Hyergranulation Tool as well as the design of future HG intervention trials.
Male or female participants between 2 to 85 years of age (both inclusive).
Willing and able to provide written informed consent or assent (as applicable) as evidenced by signature on the participant's consent/assent form. In case if the child is providing assent, a caregiver or LAR must sign an informed consent.
a VLU unhealed for a minimum of 6 weeks, but no longer than 24 weeks
an unhealed surgical wound that has been unhealed for at least 2 weeks but no longer than 24 weeks
Unable to provide informed consent or assent
Unable to complete the scheduled study treatments and assessments
Have been previously recruited into this study
Participants who are < 2 years or >85 years of age
Approximately 80-100 participants who meet the inclusion criteria will be be recruited into the study. Participants will be recruited from tissue viability clinics, burns clinics and wound care clinics across the North West of England.
Case-control
Cross-sectional
Hypergranulation Tool Proforma
Diagnostic testThis is an observational study, no IMP will be used. Patients will continue to receive best evidenced based care. Patients will attend clinic 2-4 times. Investigators will use the Hypergranulation Tool Proforma as designed by a roundtable of clinical experts at each clinic visit to clinically assess wounds for the degree of hypergranulation present. The wound will be clinically reviewed based on 5 parameters. This enables clinicans to quantify the degree of hypergranuation of wounds and allow for assessment of wound healing over clinic visits. This will be compared to 3D images of the wound and already validated Patient Reported Outcome Forms (PROMIS) will be competed and exit patient interviews. The data collected will aim to validate a method for assessment of hypergranulation of wounds in the clinical setting to help inform future Phase II clinical trials.
Device to take 2D images of wounds to allow for construction of a 3D image of the wound to assess degree of hypergranulation
DeviceThis is an observational study, no IMP will be used. Patients will continue to receive best evidenced based care. Patients will attend clinic 2-4 times. Images using a device creating 2D images to allow for a 3D image to be created of the wound. The 3D image will allow for assessment of the volume/ height of hypergranulation and the percentage of the wound affected. This will also produce data on the use of 3D in assessing wound healing over the clinic visits. investigators will also use the Hypergranulation Tool Proforma as described above and the already validated Patient Reported Outcome Forms (PROMIS) will be competed and exit patient interviews. The data collected will aim to validate a method for assessment of hypergranulation of wounds in the clinical setting to help inform future Phase II clinical trials.
To determine the performance of 3-D photographs as a tool to assess HG wound tissue as compared to Hypergranulation Tool Proforma clinical asssesment
3D images will be compared to the clinical assessment by the Hypergranulation Tool Proforma which assesses wounds based on 5 components (bleeding and friability, colour, height, exudate, and size \[percentage of wound affected\])
To conduct and evaluate the assessment of wound healing percentage through 3-D photography compared to Study Investigator assessment with the Hypergranulation Tool
To determine the performance of 3-D photographs in assessing HG wound tissue coverage compared to assessments made by a Study Investigator with the Hypergranulation Tool Proforma
To assess the participant reported experience of HG of wound tissue through participant reported outcomes (PROs) and participant interviews
To determine the performance of 3-D photographs in assessing height of HG wound tissue compared to assessments made by a Study Investigator with the Hypergranulation Tool
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