Abstract Study Background The formation of scar adhesions represents a common long-term complication experienced by patients undergoing hand surgery. These complications result from the development of scar tissue between structures of the surgical site during the postoperative healing process. Fibrotic tissue organizing around nerves and tendons can significantly impair hand functionality. Peritendinous scar adhesions are responsible for severe limitations in hand mobility, stiffness, and reduced range of both active and passive flexion-extension movements. Perineural adhesions, on the other hand, can lead to symptoms consistent with nerve conduction disorders. The pain, joint stiffness, and functional limitations resulting from scar adhesion formation are also associated with progressive muscle atrophy due to ineffective contraction. An extensive body of literature investigates the methods developed over time to prevent and limit the formation of post-surgical scar adhesions in hand surgery. This study aims to evaluate the effectiveness of carboxymethylcellulose (CMC) and polyethylene oxide (PEO) medical device in preventing peritendinous and perineural adhesions in traumatic tendon and nerve injuries of the upper limb. Aim of the study Given the promising performance reported in the literature on the use of anti-adhesion medical device based on CMC and PEO, this study aims to retrospectively analyze the case series of the device usage at the Plastic Surgery Clinic of the Azienda Ospedale-Università of Padua to evaluate the long-term outcomes of anti-adhesion gel infiltration in terms of mobility preservation, sensitivity, and pain reduction in patients undergoing lysis of peritendinous (tenolysis), periarticular (arthrolysis), and perineural (neurolysis) adhesions following traumatic events. Materials and Methods All patients (n = 27) who, since the introduction of the medical device into clinical practice (starting from 2015) in the Plastic Surgery Unit, underwent anti-adhesion medical device infiltration during post-traumatic revision surgery were selected. The follow-up of these patients was retrospectively studied with particular attention to the persistence of mobility limitations and symptoms related to nerve conduction alteration. Patients operated on at the Clinic were re-evaluated in April-May 2024 through a follow-up visit, during which residual disability and persistent pain symptoms were analyzed (using VAS, qDASH, and DN4 questionnaires). Results The analysis yielded positive results, showing that the use of the anti-adhesion medical device in post-traumatic revision surgery significantly contributes to the resolution of painful symptoms (mean decrease of 0.7 points). The reduction of symptoms compatible with neuropathic pain regressed in 40% of patients who reported it. Finally, disability reduction was around 20 points on the qDASH, highlighting the good efficacy of the studied device. Conclusions The use of the anti-adhesion medical device based on CMC and PEO showed a significant reduction in hand disability and pain symptoms in patients with outcomes of tendon and nerve structure traumas of the hand. This device, therefore, appears to be a promising resource for the prevention and/or treatment of scar adhesions in the hand, in conjunction with other measures studied in the literature to reduce the formation of such adhesions. Although this medical device has been approved for clinical use in over 50 countries since 2020, randomized and controlled studies to evaluate the long-term efficacy of CMC and PEO medical device infiltration compared to the current gold standard have not yet been concluded.
Abstract Presupposti dello studio La formazione di aderenze cicatriziali rappresenta una complicanza a lungo termine comune nei pazienti sottoposti a interventi di chirurgia della mano. Queste aderenze, che si sviluppano durante il processo di guarigione post-operatoria, consistono in tessuto fibrotico che si organizza attorno a nervi e tendini, compromettendo la funzionalità della mano. Le aderenze peri-tendinee limitano severamente la mobilità della mano, causando rigidità e riduzione dei movimenti di flesso-estensione attivi e passivi. Le aderenze peri-nervose possono generare disturbi della conduzione nervosa. Il dolore, la rigidità articolare e le limitazioni funzionali associati alle aderenze cicatriziali portano infine a una progressiva atrofia muscolare. Numerosi studi in letteratura hanno esplorato modalità per prevenire e limitare la formazione di aderenze cicatriziali post-chirurgiche nella chirurgia della mano. Questo studio valuta l'efficacia di un dispositivo medico a base di carbossi-metil-cellulosa (CMC) e ossido di polietilene (PEO) nella prevenzione delle aderenze peri-tendinee e peri-nervose in esiti traumatici dell'arto superiore. Scopo dello studio Considerate le promettenti performance del dispositivo medico anti-aderenziale a base di CMC e PEO, il presente studio analizza retrospettivamente l'uso del dispositivo presso la Clinica di Chirurgia Plastica dell'Azienda Ospedale-Università di Padova. Si valutano a lungo termine gli outcome in termini di preservazione della mobilità, sensibilità e riduzione del dolore in pazienti sottoposti a lisi delle aderenze peri-tendinee (tenolisi), peri-articolari (artrolisi) e peri-nervose (neurolisi) a seguito di eventi traumatici. Materiali e metodi Sono stati selezionati 27 pazienti sottoposti a infiltrazione del dispositivo anti-aderenziale Dynavisc dal 2015. Il follow-up retrospettivo di questi pazienti ha esaminato la persistenza di limitazioni della mobilità e della sintomatologia riconducibile ad alterazioni della conduzione nervosa. I pazienti sono stati rivalutati nell'aprile-maggio 2024 tramite visita di controllo, analizzando la disabilità residua e la persistenza del dolore con i questionari VAS, qDASH e DN4. Risultati L'analisi ha mostrato risultati positivi, evidenziando che l'uso del dispositivo anti-aderenziale contribuisce significativamente alla riduzione del dolore (-0.7 punti di media). La sintomatologia compatibile con dolore neuropatico è regredita nel 40% dei pazienti. La riduzione della disabilità si attesta intorno ai 20 punti del qDASH, indicando una buona efficacia del dispositivo studiato. Conclusioni L'utilizzo del dispositivo medico anti-aderenziale a base di CMC e PEO ha mostrato una significativa riduzione della disabilità della mano e della sintomatologia dolorosa in pazienti con esiti di traumatismi delle strutture tendinee e nervose della mano. Questo dispositivo rappresenta una promettente risorsa per la prevenzione e/o il trattamento delle aderenze cicatriziali nella mano, in associazione ad altre misure di riduzione delle aderenze studiate in letteratura. Sebbene tale dispositivo medico sia approvato per l'uso clinico in oltre 50 Paesi dal 2020, studi randomizzati e controllati per valutarne l'efficacia a lungo termine rispetto al gold standard in atto non sono ancora stati conclusi.
Il ruolo di Carbossi-Metil-Cellulosa e Ossido di Polietilene nel trattamento dei postumi traumatici tendinei e nervosi dell'arto superiore.
BATTISTELLI, NICCOLÒ
2023/2024
Abstract
Abstract Study Background The formation of scar adhesions represents a common long-term complication experienced by patients undergoing hand surgery. These complications result from the development of scar tissue between structures of the surgical site during the postoperative healing process. Fibrotic tissue organizing around nerves and tendons can significantly impair hand functionality. Peritendinous scar adhesions are responsible for severe limitations in hand mobility, stiffness, and reduced range of both active and passive flexion-extension movements. Perineural adhesions, on the other hand, can lead to symptoms consistent with nerve conduction disorders. The pain, joint stiffness, and functional limitations resulting from scar adhesion formation are also associated with progressive muscle atrophy due to ineffective contraction. An extensive body of literature investigates the methods developed over time to prevent and limit the formation of post-surgical scar adhesions in hand surgery. This study aims to evaluate the effectiveness of carboxymethylcellulose (CMC) and polyethylene oxide (PEO) medical device in preventing peritendinous and perineural adhesions in traumatic tendon and nerve injuries of the upper limb. Aim of the study Given the promising performance reported in the literature on the use of anti-adhesion medical device based on CMC and PEO, this study aims to retrospectively analyze the case series of the device usage at the Plastic Surgery Clinic of the Azienda Ospedale-Università of Padua to evaluate the long-term outcomes of anti-adhesion gel infiltration in terms of mobility preservation, sensitivity, and pain reduction in patients undergoing lysis of peritendinous (tenolysis), periarticular (arthrolysis), and perineural (neurolysis) adhesions following traumatic events. Materials and Methods All patients (n = 27) who, since the introduction of the medical device into clinical practice (starting from 2015) in the Plastic Surgery Unit, underwent anti-adhesion medical device infiltration during post-traumatic revision surgery were selected. The follow-up of these patients was retrospectively studied with particular attention to the persistence of mobility limitations and symptoms related to nerve conduction alteration. Patients operated on at the Clinic were re-evaluated in April-May 2024 through a follow-up visit, during which residual disability and persistent pain symptoms were analyzed (using VAS, qDASH, and DN4 questionnaires). Results The analysis yielded positive results, showing that the use of the anti-adhesion medical device in post-traumatic revision surgery significantly contributes to the resolution of painful symptoms (mean decrease of 0.7 points). The reduction of symptoms compatible with neuropathic pain regressed in 40% of patients who reported it. Finally, disability reduction was around 20 points on the qDASH, highlighting the good efficacy of the studied device. Conclusions The use of the anti-adhesion medical device based on CMC and PEO showed a significant reduction in hand disability and pain symptoms in patients with outcomes of tendon and nerve structure traumas of the hand. This device, therefore, appears to be a promising resource for the prevention and/or treatment of scar adhesions in the hand, in conjunction with other measures studied in the literature to reduce the formation of such adhesions. Although this medical device has been approved for clinical use in over 50 countries since 2020, randomized and controlled studies to evaluate the long-term efficacy of CMC and PEO medical device infiltration compared to the current gold standard have not yet been concluded.| File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/65841