Authors' objectives: Surgical reconstruction to close a severe pressure ulcer has not been evaluated. Surgical reconstruction (SR) to close a severe pressure ulcer (SPU) compared with management without reconstruction [no surgical reconstruction (NSR)] has not been evaluated. A planned randomised controlled trial (RCT) was unsuccessful because the surgical procedures requiring evaluation, the comparator, or the patient groups to be studied could not be defined. Three workstreams (WSs) addressed uncertainties in elements of the research question about the effectiveness and cost-effectiveness of SR. Objectives were to: perform systematic reviews and surveys (WS1) to: Obj1 (a) estimate the effectiveness of SR to close SPUs (review 1) and (b) the impact of pressure ulceration on health-related quality of life (HRQoL; review 2) Obj2 elicit responses from healthcare professionals to describe patients referred for a surgical opinion about SR, procedures performed and post-SR care, and usual care before initiating a referral use routinely collected primary care and hospital data (WS2) to: Obj3 describe patients with incident SPUs and their care pathways Obj4 describe patients diagnosed with SPU at hospital admission, their care pathways and health outcomes Obj5 compare outcomes in groups of patients, similar on hospital admission, who did or did not have SR and explore subgroup interactions with SR seek consensus (WS3) about: Obj6 appropriate treatments and management strategies.

Authors' results and conclusions: 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  70% of the surgical reconstructions. Comparing surgical reconstruction (n = 325) versus no surgical reconstruction (n = 1474) patients, time to next admission with a severe pressure ulcer was longer in patients having surgical reconstruction (hazard ratio = 0.79, 95% confidence interval 0.61 to 1.03; p = 0.07). Estimated pressure ulcer incidence in primary care was ≈ 5/10,000, but the true incidence was believed to be ≈ 7 times higher. Episodes of pressure ulcer care could not be identified. There was consensus about a referral pathway for severe pressure ulcer patients wanting surgical reconstruction, including both community-led and surgically led multidisciplinary team meetings, and about the influence of several patient and severe pressure ulcer characteristics on suitability for surgical reconstruction. 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. Workstream 1 review 1 No study compared participants who did and did not have SR. One RCT (20 participants; high risk of bias) and two retrospective cohort studies (165 participants and 181 ulcers; both at critical risk of bias) compared different flap techniques for SR. The average duration of follow-up was 19 months in the RCT, not described for one NRSI and 55 months in the other. Few relevant outcomes were reported numerically and fully. No study reported wound-free time. In the RCT, recurrence percentages were 10% and 60% in the alternative flap groups. Recurrence rates in the NRSIs were 19% (average follow-up duration not reported) and 16%. There is no high-quality evidence about the effectiveness of SR versus NSR nor how SPUs impact on HRQoL. SR is performed too infrequently in England to permit primary quantitative research. SR is commissioned in Wales, but the small population means few procedures are performed. There is indirect or anecdotal evidence that SR is effective and, were SR commissioned in England as in South Wales, a RCT might be feasible. SR procedures and the characteristics of suitable patients are known; relevant outcomes can be collected and should include HRQoL.

Authors' methods: Systematic reviews; surveys; binary choice experiment; retrospective cohort studies using routine data; consensus meeting. General practitioners; nurses; and surgeons managing pressure ulcers; people with incident pressure ulcers and hospitalised with severe pressure ulcers. 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. Workstream 1 Reviews used established methods. Review 1 (Obj1) searched for RCTs and non-randomised studies of interventions (NRSI) of SR to close a SPU. Review 2 (Obj2) searched only for RCTs of pressure ulcer (PU) prevention or treatment. Surveys were developed for general practitioners (GPs), and nurses and surgeons managing SPUs, using SurveyMonkey® (Palo Alto, CA, USA), with free-text boxes for additional responses. GPs were asked about their knowledge of SR, referrals to secondary care for SPUs, and factors influencing referrals. Nurses’ and surgeons’ surveys asked about SR and other treatments, how characteristics of SPUs and patients influenced referral decisions, SPU recurrence and barriers to SR. A binary choice experiment (BCE; Obj2) explored how patient/SPU characteristics interact to influence decisions to consider SR. Nurse and surgeon participants made consider/do not consider decisions about suitability for SR for patients described in many hypothetical scenarios, created with different permutations of characteristics. Hospital Episode Statistics (HES) data linked with Office for National Statistics (ONS) mortality data for 1 April 2010–31 March 2019 comprised data for adults (> 18 years) diagnosed in England with SPU (International Classification of Diseases-10 codes L89.2 or L89.3 or L89.9 or L89.X) during any finished consultant episode. Clinical Practice Research Datalink (CPRD) data linked with HES and ONS mortality data for the period from 1 April 2008 to 31 March 2019 comprised data for adults (> 18 years) during up-to-standard registration with a Read or Systemized Nomenclature of Medicine code indicating a PU. Read codes for discharge from or referral to a service were identified. SR was defined as for the HES cohort. The surveys considered factors only one by one; this limitation was mitigated by the BCE which gave consistent results. The BCE was able to investigate only a small number of factors. Analyses of the HES cohort depended on coding accuracy. To address this uncertainty, we described maximum and minimum SR numbers based on different assumptions informed by the research team. The target trial emulation may have used an inappropriate comparator group due to limited understanding of the referral pathway to secondary care. We could not mitigate this limitation. Outcomes typically measured in wound research are not captured in HES data and could not be investigated. Analyses of the CPRD cohort underestimated PU incidence and episodes of PU care could not be described due to inadequate coding. The consensus meeting had to be online and did not include surgeons. We mitigated this limitation by discussing the findings with research team members, who had wide-ranging relevant expertise. The COVID-19 pandemic caused delays, made team members less available and restricted face-to-face meetings. The last team meeting provided important insights about the referral pathway and factors that the patient and the surgeon need jointly to consider when deciding whether to have SR. The complexity of decision-making had not been evident or explored previously in virtual meetings.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR127850

Year Published: 2025

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/DWKT1327

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/DWKT1327

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk