Introduction
Achieving effective intra-operative haemostasis is fundamental to surgical safety, enabling clear visualisation of the operative field, reducing the risk of iatrogenic injury and improving patient outcomes. Failure to control bleeding can prolong surgery, increase the risk of complications, extend hospital stays and, in severe cases, necessitate blood transfusion.
In Ear Nose Throat (ENT) surgery, haemostatic challenges are amplified by narrow anatomical corridors, limited surgical access and the proximity of critical neurovascular structures. This applies across the full surgical spectrum—from routine procedures such as tonsillectomy, septoplasty and endoscopic sinus surgery (ESS) to more complex interventions including frontal sinus drill-out, skull base, head and neck, orbital and TransOral Robotic Surgery (TORS). Meticulous haemostasis is crucial to minimise complications such as airway obstruction, nerve injury and, in rare cases, mortality.
When conventional haemostatic techniques such as electrocautery, suture ligation, or direct pressure are insufficient, topical haemostatic agents provide an essential adjunct.Reference Brown and Solomon1 These agents help maintain a clear surgical field, minimise blood loss, reduce operative time and improve surgical outcomes. Mechanical packs, such as non-absorbable Merocel and absorbable Nasopore, achieve haemostasis by applying direct pressure to bleeding points. Absorbable haemostats, including SURGICEL® original (woven) and SURGICEL FIBRILLAR™ (non-woven), swell upon application to form a resorbable matrix for clot formation, thereby achieving haemostasis.Reference Gupta, Mohanty and Verma2, Reference Razali, Vijakumaran, Fauzi and Lokanathan3 Topical haemostats, such as the widely used gelatin-thrombin-based injectable matrices Floseal® and Surgiflo®, facilitate blood clotting through a dual mechanism, that is, contact activation and the enzymatic action of thrombin. Tisseel®, a two-component fibrin sealant, combines sealer protein and thrombin upon application, effectively replicating the final stages of the coagulation cascade to promote haemostasis.Reference Irfan, Mohd Zubir, Suwandi, Haris, Jaswir and Lestari4, Reference Ramaiola, Lopez, Moron, Maduell, López, Marzo and Grancha5 However, these products require preparation and mixing prior to use, making the process time-consuming.
In recent years, unique self-assembling peptides (SAP) have emerged, that form distinct structures resembling natural extracellular matrix. A notable SAP is RADA16, commercialised as PuraBond® (3-D Matrix Europe SAS). It is available in pre-filled syringes as a viscous solution of synthetic 2.5 per cent RADA16 that forms a stable transparent hydrogel upon contact with blood or physiological fluids, promoting local haemostasis. PuraBond is a resorbable and biologically inert haemostat with good biocompatibility and long-term stability. It is non-immunogenic, requires no prior preparation and does not expand, making it particularly safe for use in confined spaces such as the orbit, oral cavity, oropharynx, nasal cavity and the larynx. PuraBond’s applications span general, cardiovascular, gastrointestinal, ENT and neurosurgery including minimally invasive procedures, underscoring its versatility and efficacy.Reference Sankar, O’Neill, Bagot d’Arc, Rebeca, Buffier and Aleksi6
Despite its growing use, large-scale data on PuraBond® in otolaryngology remains limited. This study presents the first single-institution ENT registry documenting PuraBond® use across 600 consecutive patients at University Hospitals Birmingham NHS Foundation Trust, evaluating its clinical applications, haemostatic outcomes and safety across diverse ENT procedures and patient populations. The primary objective of this observational registry was to evaluate the clinical utility of Purabond® as a haemostatic option within the ENT surgical armamentarium, rather than to replace established haemostatic methods. Scientific advancement in surgical practice is inherently incremental, progressing through the systematic evaluation and integration of novel techniques alongside conventional approaches. Traditional haemostatic procedures remain foundational to ENT surgery; however, the addition of innovative haemostatic agents may offer advantages in specific clinical scenarios where conventional methods prove challenging or suboptimal. By documenting real-world outcomes in a diverse patient population, this study aims to inform evidence-based decision-making regarding the appropriate integration of PuraBond® into contemporary surgical practice.
Materials and methods
Study design
A single-site, two-cycle observational study conducted at University Hospitals Birmingham (UHB) NHS Foundation Trust, U.K to systematically document PuraBond® use and outcomes in ENT surgical procedures.
Cycle 1 (Retrospective Audit): Data were retrospectively extracted from patient medical records for all ENT procedures utilising PuraBond® performed between 12 September 2019 and10 October 2023 to establish baseline usage patterns and outcomes.
Cycle 2 (Prospective Audit): Data were prospectively collected for all ENT procedures utilising PuraBond® performed between 11 October 2023 and 11 July 2024. This allowed for prospective validation of findings and real-time data collection. No interventions or changes to surgical practice were introduced between cycles; both phases served to establish a comprehensive registry of PuraBond® applications in routine clinical practice. The two-cycle approach was employed to capture historical and concurrent data collection.
PuraBond® application protocol
PuraBond® was used either as a standalone haemostatic agent or as an adjunct following standard surgical techniques. The decision to use PuraBond was made intra-operatively by the operating surgeon based on clinical judgment and procedural requirements. Applications included prophylactic haemostasis to raw mucosal surfaces, dissection beds, or surgical cavities, rescue haemostasis following primary haemostatic manoeuvres (electrocautery, suture ligation) at sites with persistent oozing not adequately controlled by conventional methods and preferential application for haemostasis at confined spaces (orbit, skull base, larynx) where its non-expanding, transparent properties were considered advantageous.
PuraBond® was not intended to replace conventional techniques but as an adjunct. Other routine haemostatic measures employed during ENT surgeries include nasal packing materials (Merocel®, Nasopore®), absorbable haemostats (SURGICEL®), flowable matrices (Floseal®) and electrocautery as required. However, systematic documentation of concurrent agent use was not performed as the operative notes were reviewed for data, and surgeons may not consistently record every haemostatic modality employed intra-operatively such as electrocautery.
Data collection
For all cases meeting the inclusion criteria, the following data were systematically extracted by reviewing intra-operative records, inpatient clinical notes, discharge summaries, outpatient follow-up documentation and emergency department records: Patient demographics, comorbidities, special conditions (hereditary haemorrhagic telangiectasia, haemophilia, coagulopathies); Use of anticoagulants/antiplatelets, timing of discontinuation and re-bleeding episodes were recorded from A&E/readmission notes; Surgical details, including primary diagnosis, date of procedure, ENT subspecialty category, operating consultant, type of anaesthesia, specific operative procedure, anatomical site of PuraBond® application, volume of PuraBond® used; Intra-operative haemostatic success and the need for additional haemostatic measures including estimated blood loss (when documented); Length of hospital stay (planned versus unplanned extension), readmission within 30 days and emergency department attendance; Immediate haemostasis-related complications (post-operative bleeding requiring intervention, haematoma formation), delayed complications (seroma, secondary haemorrhage, adhesion formation, infection) and complications unrelated to haemostasis or PuraBond® use.
It should be noted that specific complications, such as seroma formation and nasal adhesions, were not prospectively sought using standardised assessment tools but were recorded when documented in routine clinical notes and follow-up examinations.
Inclusion criteria
All ENT patients where PuraBond® was used during ENT surgical procedures. To ensure no case was overlooked, the search included common misspellings of PuraBond.
Exclusion criteria
Cases where PuraBond® was not used, or where clinical documentation was insufficient to extract the required data elements.
Data from both cycles were combined and analysed descriptively. Results were categorised by ENT subspecialty. As this was an observational registry without a control group, no comparative statistical analyses were performed. The heterogeneity of procedures and subspecialties resulted in small sample sizes for individual procedure types, limiting the statistical power for subgroup comparisons. Data were analysed using SPSS version 29 (IBM Corporation). Continuous variables are presented as means with ranges, and categorical variables as frequencies and percentages.
This study was conducted as a clinical audit in accordance with University Hospitals Birmingham NHS Foundation Trust governance policies. All data were anonymised and managed in compliance with the General Data Protection Regulation (GDPR) and institutional data protection protocols. As a service evaluation and audit of routine clinical practice, formal ethical approval was not required. The study was registered with the Clinical Audit and Research Management System (CARMS) under audit number 20807.
Results
Patient demographics and characteristics
The study cohort comprised 600 patients (331 females; 269 males) aged 17 to 92 years who underwent ENT procedures utilising PuraBond as a haemostatic agent between September 2019 and July 2024. Common comorbidities included hypertension (n = 159; 26.5 per cent), diabetes mellitus (n = 91; 15.2 per cent), cardiovascular disease (n = 82; 13.7 per cent) and asthma (n = 80; 13.3 per cent). The cohort also included patients with complex bleeding disorders: hereditary haemorrhagic telangiectasia (n = 8; 1.3 per cent) and haemophilia (n = 5; 0.8 per cent), indicating inclusion of high-risk populations (Figure 1).
Bar chart showing the prevalence of comorbidities in the patient cohort, with hypertension (n = 159) and diabetes mellitus (n = 91) being the most common.
Figure 1 Long description
A horizontal bar graph titled COMORBIDITIES. X axis label: Number of patients. X axis range: 0 to 180. Y axis label: Type of comorbidity. Legend labels: Syndromes; Crohn’s; IBS; Coeliac disease; COPD; OSA; arthritis; Obesity; Asthma; Heart slash Cardiovascular disease; Anaemia; Stroke; Coagulopathies; Cirrhosis; DM; HTN. Bar values shown on the chart: HTN 159; DM 91; Heart slash Cardiovascular disease 82; Asthma 80; Obesity 31; Anaemia 23; Stroke 17; arthritis 13; OSA 13; Cirrhosis 12; Coagulopathies 12; COPD 9; Coeliac disease 8; Syndromes 8; Crohn’s 6; IBS 2.
Anticoagulation and antiplatelet therapy
Forty-seven patients (7.8 per cent) were receiving antiplatelet or anticoagulant therapy at the time of surgery. These included aspirin (n = 20), clopidogrel (n = 11), apixaban (n = 7), edoxaban (n = 6), warfarin (n = 2) and enoxaparin (n = 1). Antithrombotic medication was discontinued pre-operatively in 43 patients (91.5 per cent), typically one week prior to surgery as per institutional protocols. Four patients (8.5 per cent) continued antithrombotic therapy peri-operatively due to high thrombotic risk associated with their cardiovascular comorbidities. Among the four patients who continued antithrombotic therapy, only one experienced a post-operative bleeding complication—a small superficial haematoma that resolved spontaneously within one week. This patient had concurrent deranged liver function, which likely contributed to the bleeding tendency. The remaining three patients, who continued antithrombotic therapy and had no post-operative bleeding complications were as follows: Patient 1 with Marfan syndrome and an enlarged aorta (on aspirin) underwent hemithyroidectomy for multifocal papillary carcinoma; Patient 2, with a history of Pulmonary Embolism (PE) (on apixaban) underwent thyroidectomy; Patient 3 with a history of deep vein thrombosis (DVT) and PE (on apixaban) underwent nasal turbinate reduction surgery.
Surgical procedures by subspecialty
Surgical procedures by subspecialty are listed here. Head and neck surgery: 261 procedures (43.5 per cent), including transoral robotic surgery (TORS; n = 47); Rhinology and skull base surgery: 236 procedures (39.3 per cent); Facial plastic surgery: 59 procedures (9.8 per cent); General ENT: 44 procedures (7.3 per cent); Orbital surgery was performed in 34 patients (5.7 per cent), including orbital decompression (n = 18), orbital exenteration (n = 4), endoscopic dacryocystorhinostomy (n = 5), excision of sphenoid wing meningiomas via transorbital approach (n = 5) and transorbital excision of cavernous haemangiomas (n = 2). No post-operative orbital complications or bleeding events were documented in these cases (Figures 2 and 3).
Bar chart showing the distribution of ENT sub-specialties for PuraBond® use, with head neck (n = 261) and rhinology (n = 236) being the most common, followed by facial plastics (n = 59) and general ENT (n = 44).
Figure 2 Long description
The title reads E N T Specialty. The horizontal axis shows values from 0 to 300. The vertical axis lists Facial Plastics, General E N T, Rhinology, Head Neck. Bar end labels show Facial Plastics 59, General E N T 44, Rhinology 236, Head Neck 261. A table below lists Head neck 261, Rhinology 236, Facial Plastics 59, General E N T 44.
Distribution of procedures using PuraBond®, with bar charts (A, B) showing head and neck (A) and rhinology (B) procedures and pie charts (C, D) depicting facial plastics (C) and general ENT (D) procedures.
Figure 3 Long description
The image contains four graphs depicting surgical procedures by subspecialty. A) The bar graph titled 'Head Neck Procedures' shows procedure counts for various types. The x-axis lists procedure types and the y-axis represents counts. Thyroid surgeries have the highest count at 129, followed by TORS at 47 and parotid surgeries at 27. B) The bar graph titled 'Rhinology Procedures' displays procedure counts. The x-axis lists procedure types and the y-axis represents counts. Nasal surgeries have the highest count at 72, followed by sinus surgeries at 30 and surgeries for malignancy at 28. C) The pie chart titled 'Facial Plastics Procedures' shows procedure distribution. Septorhinoplasties account for the largest portion with 46 procedures, followed by scalp lesion excisions at 6 and excisions for basal cell carcinoma at 5. D) The pie chart titled 'General ENT Procedures' shows procedure distribution. Tonsillectomies account for the largest portion with 37 procedures, followed by post-operative bleeding at 5 and post-operative abscess drainage at 2. Overall, thyroid surgeries and nasal surgeries are the most common procedures in their respective categories, highlighting the prevalence of these procedures in the dataset.
Anaesthesia
General anaesthesia was used in 597 cases (99.5 per cent). Local anaesthesia was used in three cases (0.5 per cent): endoscopic middle meatal antrostomy, nasal skin lesion excision with flap reconstruction and division of nasal adhesions.
Haemostatic efficacy
Intra-operative haemostasis was documented without a need of additional haemostatic intervention in 599 of 600 patients (99.8 per cent). Although, in the absence of a control group, these outcomes cannot be definitively attributed to PuraBond® alone. Haemostatic success was defined as the achievement of satisfactory bleeding control allowing completion of the surgical procedure without the need for additional intra-operative intervention beyond standard post-operative care protocols. One patient (0.2 per cent) required additional haemostatic intervention post-operatively, consisting of administration of tranexamic acid and placement of additional nasal packing. This patient was maintained on anticoagulation therapy and had deranged liver function. In seven patients (1.2 per cent), PuraBond was applied to manage post-operative bleeding, although it was not used during the initial surgical procedure. These included post-operative bleeding following parathyroid surgery (n = 1), tonsillectomy (n =5) haematoma at the skin graft harvest site in a patient on aspirin (n = 1). PuraBond successfully controlled bleeding in all seven cases without the need for further intervention.
Post-operative hospital stay
A total of 473 patients (79 per cent) were discharged within 24 hours of surgery. N = 127 patients (21 per cent) required a hospital stay exceeding 24 hours. Of these, 115 patients had pre-planned extended admissions due to the complexity of their procedures (e.g., major head and neck cancer resections, extensive skull base surgery). N = 12 patients had unplanned extended hospital stays with reasons unrelated to PuraBond use or haemostasis issues, including pyrexia (n = 2), calcium (Ca) and parathyroid hormone (PTH) imbalances requiring correction before discharge (n = 3), post-laryngectomy chyle leaks (n = 2), post-operative neck seromas (n = 2), preexisting hepatic failure (n = 1) and mental health concerns (n = 2).
Complications
Immediate haemostasis-related complications: Only one patient (0.17per cen; 95 per cent confidence interval [CI]: 0.00–0.93 per cent) experienced an immediate complication directly related to haemostasis: a small post-operative haematoma following right hemithyroidectomy, managed conservatively without surgical intervention and resolved within a week. The remaining 599 patients (99.83 per cent) had no immediate haemostasis-related complications.
Delayed complications: Seven patients (1 per cent) experienced delayed complications occurring between post-operative days 4 and 15. These included seroma formation after thyroid surgery (n = 2; 1.5 per cent), superficial haematoma at skin graft harvest site (n = 1), secondary haemorrhage after tonsillectomy (n = 2; 5.4 per cent of 37 tonsillectomies), secondary tongue base bleeding after TORS (n = 1; 2.1 per cent of 47 TORS procedures) and nasal adhesions (n = 1; 0.2 per cent of 236 rhinology/skull base procedures). It is important to note that secondary haemorrhage after tonsillectomy and TORS procedures typically occurs 7–14 days post-operatively due to eschar separation and is not directly attributable to the haemostatic agent used intra-operatively.
Twelve patients (2.0 per cent) experienced complications unrelated to haemostasis or PuraBond® use, including hypocalcaemia following thyroidectomy (n = 3), internal carotid artery injury (n = 1), Cerebrospinal fluid rhinorrhoea (n = 1), chyle leak after laryngectomy (n = 2), odynophagia (n = 2), marginal mandibular nerve weakness (n = 1) and wound dehiscence (n = 2). The overall complication rate in the cohort was 3.3 per cent (n = 20). Haemostatic outcomes and complications are listed in Table 1.
Haemostatic outcomes and complications
Table 1 Long description
The table summarizes haemostatic outcomes and complications, reporting counts with percentages and confidence intervals where available. Intra-operative haemostasis was achieved in 599 cases (99.8%), and only 1 case (0.2%) required an additional intervention. Immediate haemostasis-related complications were rare at 1 case (0.17%). Delayed complications occurring between post-operative days 4 and 15 were reported in 7 cases (1.2%), including seroma after thyroidectomy (2 cases, 0.3%), secondary haemorrhage after tonsillectomy (2 cases, 0.3%), secondary bleeding after transoral robotic surgery (1 case, 0.2%), nasal adhesions (1 case, 0.2%), and superficial haematoma (1 case, 0.2%). Complications unrelated to haemostasis occurred in 12 cases (2.0%). The overall complication rate was 20 cases (3.3%), indicating that most patients had successful haemostasis with relatively few complications.
CI = confidence interval; POD = post-operative day.
Discussion
This observational registry represents the largest single-institution experience with PuraBond® in ENT surgery reported to date, documenting outcomes across 600 consecutive patients and diverse ENT subspecialties. The findings demonstrate PuraBond’s broad applicability across multiple anatomical sites and patient populations, including high-risk individuals with bleeding disorders and those maintained on anticoagulation therapy.
In this observational series, intra-operative haemostasis was documented in 99.8 per cent of cases in which PuraBond® was used as part of the haemostatic approach. While the observational design limits causal inference, the consistent performance across diverse procedures supports its role as an effective adjunct. The immediate complication rate of 0.2 per cent compares favourably to typical ENT surgery rates (>1 per cent). These findings provide preliminary evidence justifying future randomised controlled trials to quantify PuraBond’s specific haemostatic contribution versus standard techniques.
The safety profile of PuraBond® in this series was favourable, with minimal complications directly attributable to the agent. The immediate haemostasis-related complication rate was 0.17 per cent (1/600), consisting of a single small post-operative haematoma that resolved conservatively. No allergic reactions, inflammatory responses, or serious adverse events related to PuraBond® were observed in this cohort.
PuraBond’s non-expanding property is an advantage in confined anatomical spaces. The use of PuraBond® has shown effectiveness in orbital, laryngeal and robotic procedures due to its non-expanding nature and transparent appearance. These properties are crucial in the orbit, a closed and delicate space where maintaining stable intra-orbital pressure is essential within the bony socket to avoid complications that could affect vision. In both, laryngeal and robotic procedures, PuraBond’s clear and transparent composition enables precise application without obscuring the surgical field or airway, while also supporting optimal healing and preserving the vocal and swallowing function. The transparent nature of PuraBond® allows for clear visualisation of the surgical field, which is particularly valuable in endoscopic procedures where visual clarity is paramount. This property distinguishes it from opaque haemostatic materials that may obscure anatomical landmarks.
Forty-seven patients in this series were receiving antiplatelet or anticoagulant therapy, with four patients continuing medication peri-operatively due to high thrombotic risk. While these findings suggest that PuraBond® may be safely used in anticoagulated patients, the small sample size (n = 4 continuing therapy) precludes definitive conclusions. Although larger prospective studies are needed, the ability to achieve haemostasis in this high-risk subgroup is clinically relevant given the increasing prevalence of patients on antithrombotic therapy presenting for elective surgery.
Complication rates in specific procedures
Tonsillectomy
Two of 37 patients (5.4 per cent) who underwent tonsillectomy with PuraBond® experienced secondary haemorrhage on post-operative days 9 and 11. Secondary post-tonsillectomy haemorrhage typically occurs 7–14 days after surgery due to eschar separation and sloughing, a process unrelated to intra-operative haemostasis. Published secondary haemorrhage rates after tonsillectomy range from 0.28 per cent to 20 per cent, with most studies reporting rates of 2–5 per cent.Reference Liu, Anderson, Willging, Myer, Shott and Bratcher7 Our observed rate of 5.4 per cent falls within this expected range. Importantly, PuraBond® was successfully used to control secondary bleeding in five additional patients, demonstrating its utility as a rescue haemostatic agent.
Thyroidectomy
Post-thyroidectomy haematoma, a potentially life-threatening complication, occurred in 0.8 per cent (1/129) of cases, which is within the expected range of 0.7–6.5 per cent reported in large series.Reference Jeppesen, Moos, Holm, Pedersen, Skjøt-Arkil and Nielsen8 The seroma incidence was 1.5 per cent (2/129), which falls at the lower end of the reported range in the literature of 1.3–7 per cent.Reference Ramouz, Rasihashemi, Daghigh, Faraji, Rouhani and Mohebbi9
Nasal adhesions
One patient (0.2 per cent of 236 rhinology/skull base procedures) developed nasal synechiae. Published rates of nasal adhesions after endoscopic sinus surgery range from 10 to 40 per cent, with variation depending on the extent of surgery, post-operative care protocols and duration of follow-up.Reference Gall and Witterick10
TORS procedures
Among 47 TORS procedures, one patient (2.1 per cent) experienced secondary tongue base bleeding on post-operative day 8. The first study published in 2022, evaluating the role of PuraBond® in TORS for oropharyngeal cancer, included 12 patients (13 procedures due to one second look and re-resection case).Reference Gupta, Garas, Idle, Germain and De11 No patients developed primary or secondary post-operative haemorrhage, and there were no re-attendances within 30 days with no patient requiring feeding tube insertion or tracheostomy.
PuraBond® is routinely available within our NHS operating theatres and is procured through standard NHS supply and tendering processes, in the same manner as other haemostatic agents. The supply of PuraBond® for all 600 patients in this registry was funded entirely through normal NHS hospital procurement; no product was provided or subsidised by the manufacturer for the purposes of this study. A formal cost-effectiveness analysis was beyond the scope of this observational registry. Future randomised controlled trials may incorporate health economic analyses comparing PuraBond® with standard haemostatic alternatives to inform evidence-based commissioning decisions
Study strengths
Strengths of this study include being the first UK ENT registry of PuraBond® usage with a large sample size (n = 600), inclusion of diverse patient populations with multiple comorbidities and bleeding risk factors, representation of multiple ENT subspecialties and a real-world clinical practice setting. The inclusion of high-risk patients (47 on antithrombotic agents, 159 with cardiovascular disease, 13 with haematologic disorders) enhances the generalisability of findings and provides safety data in populations typically underrepresented in clinical trials.
Study limitations
Limitations include a lack of a control group, small subspecialty samples limiting subgroup analyses, an observational design and non-randomised surgeon-directed application. Emergency attendances outside the University Hospitals Birmingham NHS Foundation Trust network (eg: local hospitals) are not captured in institutional records; however, no mention of external admissions were identified during review of available clinical documentation. Haemostatic success was defined pragmatically without systematic recording of objective metrics (time to haemostasis, quantified blood loss). However, such observational registries provide essential groundwork documenting real-world feasibility and safety before undertaking controlled trials.
What is already known on this subject:
• Effective haemostasis is critical in ENT surgery due to narrow operative corridors and proximity to vital structures.
• Self-assembling peptide haemostats have shown promise in small-scale studies.
• There is limited large-scale data on PuraBond® use in otolaryngology.
What this study adds: -
• Largest single-institution ENT observational registry in the UK evaluating PuraBond® use to date (600 patients).
• Safety and applicability data across diverse patient populations, including those on anticoagulation therapy.
• Observational outcomes across multiple ENT subspecialties (head and neck, rhinology, skull base, laryngology, facial plastics and orbital surgery) highlight safe usability as an adjunct hemostatic agent but controlled comparative trials to establish definitive efficacy are needed.
• This study establishes foundational evidence of PuraBond's safety and reliability as a haemostatic agent in ENT surgery, providing the groundwork for future controlled trials.
Conclusion
This 600-patient registry represents the largest single-institution experience with self-assembling peptide haemostats in ENT surgery. Adequate intra-operative haemostasis was achieved in 99.8 per cent of cases across diverse procedures and high-risk populations, with an immediate complication rate of 0.2 per cent and no serious adverse events. Its non-immunogenic and ready-to-use profile, compatibility with electrocautery devices and transparent, non-expanding characteristics contribute to its clinical utility. These findings support continued clinical use and provide groundwork for prospective randomised controlled trials incorporating standardised endpoints, active comparators and health economic analyses.
Acknowledgements
The authors gratefully acknowledge the invaluable assistance of the Health Informatics team at University Hospitals Birmingham NHS Foundation Trust (UHB). Their dedicated efforts in data retrieval significantly enhanced the accuracy of our data collection process. Artificial intelligence (AI) tools were used solely to assist with language editing and improvement of readability. No AI tools were used for data analysis, interpretation, or generation of scientific content. All content was reviewed and verified by the authors
Financial support
The senior author (S.K.A.) received an unrestricted educational grant from 3D Matrix, the manufacturer of PuraBond®, to fund a Research Fellow working across multiple ENT research projects at University Hospitals Birmingham NHS Foundation Trust. This grant did not directly fund this study. The supply of PuraBond® for all 600 patients in this registry was funded entirely through routine NHS hospital procurement; no product was provided or subsidised by the manufacturer for the purposes of this study.
Competing interests
The senior author (S.K.A.) has received an unrestricted educational grant from 3D Matrix (manufacturer of PuraBond®) to support a Research Fellow. All other authors declare no competing interests. The manufacturer had no role in study design, data collection, analysis, interpretation, or the decision to submit for publication.
