Effectiveness of surgical interventions in patients with severe pressure ulcers: the SIPS mixed-methods exploratory study.

Background: Surgical reconstruction to close a severe pressure ulcer has not been evaluated. Aim and objectives: We aimed to investigate the feasibility of research to evaluate surgical reconstruction for severe pressure ulcers by: systematically reviewing evidence about: the effectiveness of surgical reconstruction for severe pressure ulcers; the impact of pressure ulceration on health-related quality-of-life (review 2) surveying primary and secondary care healthcare professionals about surgical referrals of patients with severe pressure ulcers and severe pressure ulcer management, including surgical reconstruction describing patients with incident pressure ulcers and with severe pressure ulcers having surgical reconstruction comparing outcomes in patients with severe pressure ulcers having/not having surgical reconstruction seeking consensus about treatments and management strategies for severe pressure ulcers. Design: Systematic reviews; surveys; binary choice experiment; retrospective cohort studies using routine data; consensus meeting. Participants: General practitioners; nurses; and surgeons managing pressure ulcers; people with incident pressure ulcers and hospitalised with severe pressure ulcers. Intervention: Surgical reconstruction. Comparator: No surgical reconstruction. Outcomes: Surgical reconstruction, time to next admission with a severe pressure ulcer time to next admission, hospital stay, all-cause mortality, surgical reconstruction after discharge. Results: Review 1 included three studies comparing different surgical reconstruction techniques. None reported wound-free time. Recurrence occurred in ≈ 20%. Review 2 included three randomised controlled trials measuring health-related quality of life, but none observed benefits of interventions evaluated. Among primary care survey respondents, 54% did not know surgical reconstruction can treat severe pressure ulcers; > 50% had never referred a patient to a surgeon. Among nurses, 72% had considered surgical reconstruction for a severe pressure ulcer; 54% believed surgical reconstruction should be more available. Among surgeons, 39% had never offered surgical reconstruction and 52% offered surgical reconstruction to < 50%; 68% believed surgical reconstruction should be more available. Routine data recorded 367,884 admissions with severe pressure ulcer diagnoses in England over 7.5 years; surgical reconstructions were performed in at least 404 and at most 1018 admissions. Twenty English hospitals performed > 70% of the surgical reconstructions. Comparing surgical reconstruction ( Limitations: Surveys only considered factors one by one. Analyses of the Hospital Episode Statistics cohort depended on coding accuracy. For the comparison of surgical reconstruction and no surgical reconstruction, the no surgical reconstruction group had to be admitted. Routine data do not record wound healing outcomes. Primary care data underestimated pressure ulcer incidence; pressure ulcer care episodes could not be identified. The consensus meeting did not include surgeons. The COVID-19 pandemic caused delays, made team members unavailable and restricted face-to-face meetings. Conclusions: There is insufficient evidence to determine the effectiveness of surgical reconstruction on health-related quality of life or wound healing for severe pressure ulcers. Too few procedures are carried out to enable a randomised controlled trial to be feasible. Future work: We identified three areas: qualitative research on the acceptability of surgical reconstruction and the impact of a SPU on a patient's quality-of-life; a core outcome set for interventions to treat pressure ulcers; and economic modelling of surgical reconstruction cost-effectiveness. Study registration: This study is registered as PROSPERO 2019 CRD42019156436, 2019 CRD42019156450; ISRCTN13292620. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127850) and is published in full in