ABSTRACT
Background/Purpose: Cleft Surgery in our centre is delivered by a single specialist surgeon in a regional Burns and Plastic service. We see 35-45 cleft-affected births per annum and, prior to the COVID-19 pandemic, ran 6 theatre lists per month, conducting 170-180 cleft procedures annually. The pandemic severely hindered elective operating in even tertiary centres, due to the redeployment of theatre staff and resources to manage the emergency care load. Cleft surgery was suspended entirely during the first wave (March-June 2020), before efforts in collaboration with the RCPCH (UK) to conserve the cleft pathway restored it as a priority. Primary palatine reconstruction is recommended at 6-9 months of age to optimise velopharyngeal function and speech proficiency by 5 years (Slater et al 2019). Our service was restarted at 1-2 ad hoc lists a month, which was both insufficient to manage ongoing demands and deal with rising outstanding cases. We faced a major challenge in safely distributing scarce surgical time and capacity across the entire cleft surgical burden. Therefore, we aim to examine our response to these limitations in the face of rising cases and time pressures, illustrating our methods in prioritising cleft procedures. Methods/Description: We reviewed the current literature to determine which of the main cleft procedures were most time critical, and compiled a cleft priority document with a broad evidence basis. Babies with palate involvement were top priority, in light of the strong evidence advocating primary palate repair by 13 months of age (CRANE 2020), after which there is a risk of speech delay (Shaffer et al 2020). Primary lip +/- alveolar involvement were prioritised lower and performed later (∼1 year), as cosmesis during infancy was deemed less detrimental, although there remained the psychological impact on the parent (Grollemund et al 2020). Secondary speech surgery was next, the lack of which can inhibit education and require intensive speech therapy to support patients (Baillie and Sell 2020). This was followed by alveolar bone grafting, ideally performed prior to canine eruption at ∼8-9 years to limit further dental reconstructions (Vandersluis et al 2020). As per national consensus, all adult cleft surgery was suspended to accommodate higher priorities. Focusing on early palate repair helped restart the cleft pathway and prevent functional delay as well as further interventions and schoolage support. However, late lip repair saw a rise in complications - two cases of dehiscence were associated with self-inflicted toddler trauma. This is in addition to the psychosocial implications of cosmesis, including early maternal interactions (Montirosso et al 2011), stigmatisation by peers (Bous et al 2021), and parental anxiety (Bous et al 2020). We recommend isolated lip reconstructions are also undertaken within 9 months. Long-term physical and psychosocial impacts of delay in surgery should guide resource allocation in the event of future operating limitations.
ABSTRACT
Background/Purpose: COVID-19 fundamentally changed cleft teams' ability to care for their patients. This study aims to study;1) the effect of COVID-19 on elective surgery timings and outcomes;2) preoperative screening and isolation protocols;3) the impact of operating with personal protective equipment (PPE). Methods/Description: Between the start of the first UK lockdown in March 2020 and April 2021 operative details from 651 cleft procedures performed in eight UK centres were entered into a secure REDCap database. Results: 651 records were entered (59% male, 41% female). 9% patients had a known syndrome. Operations were as follows: cleft palate repair (40%), unilateral cleft lip repair +/- vomer flap (23%), alveolar bone grafting (16%), secondary speech surgery (10%), fistula repair (3.7%), lip revision (1%) and rhinoplasty (1%). 39% of surgical cases were deemed delayed compared to normal protocol timings, with 80% of the delays attributable to COVID. Mean age at initial cleft lip repair was 230 days exceeding a previous representative mean of 137 days as well as breaching the UK national standards for upper age limit of 183 days. Mean age at cleft palate repair was 387 days compared to the UK national standard for upper age limit of 396 days, and previous representative mean of 320 days. 81% of patients undertook some form of pre-operative isolation;47% isolated for two weeks. COVID screening was performed in the 72 hrs prior to surgery in 89% of patients and 13% of parents/carers. Only one patient had a positive test. 69% surgeons wore an FFP3 (N99) mask to operate, and 64% of cases involved difficulty during the operation as a result of the PPE;most commonly communication difficulties (45%). No patients developed COVID in the early post-operative period. Conclusions: This data demonstrates that initial cleft lip and palate repair in the UK has been delayed as a direct result of the COVID-19 pandemic. Secondary surgery has been significantly affected and efforts will need to be made at national level to provide capacity to catch up. Isolation and testing protocols for COVID-19 vary from unit to unit, but appear safe. Routine cleft surgery can safely continuing through the pandemic, as long as appropriate infection control measures are followed and resources allow.
ABSTRACT
Background/Purpose: Since COVID-19 was declared a worldwide pandemic by the World Health Organization (WHO) in March of 2020, foundation-based cleft outreach programs to Low- and Middle-Income Countries (LMICs) were halted considering global public health challenges, scarcity of capacity and resources, and travel restrictions. This led to an increase in the backlog of untreated patients with cleft lip and/or palate, with new challenges to providing comprehensive care in those regions. Resumption of international outreach programs requires an updated course of action to incorporate necessary safety measures in the face of the ongoing pandemic. In this manuscript, we outline safety protocols, guidelines, and recommendations implemented in Global Smile Foundation's (GSF) most recent outreach trip to Beirut, Lebanon. Methods/Description: COVID-19 safety protocols for outreach cleft care and an Action Response Plan were developed by the GSF team based on the published literature and recommendations from leading international organizations. Results: GSF conducted a 1-week surgical outreach program in Beirut, Lebanon, performing 13 primary cleft lip repairs, 7 cleft palate repairs, and 1 alveolar bone grafting procedure. Safety protocols were implemented at all stages of the outreach program, including patient pre-selection and education, hospital admission and screening, intraoperative care, and post-operative monitoring and follow-up. Conclusions: Organizing outreach programs in the setting of infectious diseases outbreaks should prioritize the safety and welfare of patients and team members within the program's local community. The COVID-19 protocols and guidelines described may represent a reproducible framework for planning future similar outreach initiatives in high risk conditions.
ABSTRACT
BACKGROUND: Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or in combination with BCP, in a first-in-human clinical trial. METHODS: This single-blinded, parallel, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13-34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was 6 months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations. Osteoinductivity evaluation using histomorphometric analysis of biopsies was not possible due to COVID restrictions. RESULTS: Due to surgical and feasibility reasons, eventually, only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day 180). Three out of eight were unable to reach the hospital due to COVID-19 restrictions. One patient decided not to continue with the study. None of the patients showed any allergic reactions or any remarkable local or systematic side effects. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients who got the BCP/Ca-polyP MPs combination had scores ranging from I to III. CONCLUSIONS: Our results indicate that Ca-polyP MPs and the BCP/Ca-polyP MPs combination appear to be safe graft materials; however, in the current setting, Ca-polyP MPs alone may not be a sufficiently stable defect-filling scaffold to be used in alveolar cleft repair. TRIAL REGISTRATION: Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019 .