The effect of PuraBond® on postoperative pain following transoral resections of primary oral or oropharyngeal neoplastic mucosal lesions: A blinded randomised controlled study (PuraBond® PROOF)

BACKGROUND: RADA16 (PuraBond®) is a novel, synthetic agent that forms a transparent, self-assembling scaffold, mimicking human extracellular-matrix to promote haemostasis. We hypothesise this physical barrier provides effective analgesia for upper aerodigestive tract surgical wounds through nociception blockade during swallowing. This study evaluated PuraBond®'s efficacy on postoperative pain following transoral resection of oral/oropharyngeal mucosal lesions. METHODS: A prospective, blinded, single-centre, randomised controlled trial was conducted, comparing intraoperative PuraBond® application versus no topical agent. Patients undergoing transoral resection of dysplasia/malignancy of the oral cavity or oropharynx were recruited. Stratification factors included lesion site, electrosurgery versus laser technique, and concurrent neck dissection. The primary outcome measure was pain scores measured using a visual analogue scale over 30-days postoperatively. RESULTS: In total, 68 patients were recruited (70% oropharyngeal, 30% oral; PuraBond® n = 32, control n = 36) and analysed. Mean pain scores over the study period were 2.56 and 3.41 for PuraBond® and control groups respectively. The control arm had higher baseline adjusted pain scores at all timepoints, but none of these were individually statistically significant. Cumulative results however demonstrated a significantly greater increase in pain from preoperative baseline for the control group over the entire 30-day period (0.61, 95% CI 0.12-1.10, p = 0.016), with the most noticeable clinical difference during the initial week (0.77, 95% CI 0.18-1.36, p = 0.011). Although underpowered with regards to haemorrhage events, these were three-times lower with PuraBond® (p = 0.266). CONCLUSION: PuraBond® use following head and neck mucosal resections is a safe and potentially useful surgical adjunct in reducing postoperative pain. The opportunity exists, via adequately-powered studies, to assess whether the trend towards reduced haemorrhage is significant and reproducible. TRIAL REGISTRATION: NCT05773781(https://clinicaltrials.gov).