Cancer and neoplasms Cancer
Conditions
Interventions
Screening
Adults who have been referred for removal of skin cancer on the lower leg and the surgeon has decided that they will not be able to fully close the wound will be screened by the clinical te
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged > = 18 years 2. Planned excision of suspected KC on the lower leg with healing by secondary intention 3. Ankle-brachial pressure index (ABPI) > = 0.8 or toe pressure of > 60 mmHg 4. Informed written/eConsent
Exclusion criteria
Exclusion criteria: 1. Planned primary closure/skin graft/flap 2. Receiving/planned compression for another indication 3. Severe venous incompetence e.g. Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification C5 or C6 4. Contraindication to at least medium compression(18-24mmHg) 5. Unable to comply with compression 6. Suspected to have a non-KC diagnosis or require further surgery 7. Previously taken part in HEALS2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to complete healing (epithelialisation) of the surgical wound from randomisation to the date the wound is confirmed as healed measured using clinical assessment of the wound at a clinical assessment visit scheduled within 7 days of a verbal report of healing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of infection measured using the modified Bluebelle Wound Healing Questionnaire (WHQ) until healing at 4, 12, 26 and 52** weeks 2. Number of days participants were prescribed antibiotics until healing measured using participant responses during follow-up telephone calls collected weekly to 26 weeks, monthly from 26 to 52 weeks 3. Scar quality measured using the Patient and Observer Scar Assessment Scale (POSAS) at the confirmation of the healing visit 4. Safety events including related complications and hospitalisations until healing measured using participant responses during follow-up telephone calls weekly to 26 weeks, monthly from 26 to 52 weeks 5. Health-related quality of life measured using the EQ-5D-5L at baseline, 4, 12, 26, 52*** weeks 6. The relationship between post-partial wound closure area, type of partial closure method, and time to healing measured using wound area measurement calculated from maximum length and width taken during surgery, post partial closure Key **only conducted if not healed at 6 months ***Unhealed participants only | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactHEALS2 Trial Team
Outcome results
None listed