Efficacy of a Novel Intraoperative Engineered Sharps Injury Prevention Device: Pilot Usability and Efficacy Trial
Notice bibliographique
Résumé
Background The American College of Surgeons reports 88,320 intraoperative needlestick injuries (NSIs) per year, resulting in US $376 to US $2456 in costs per NSI. Engineered sharps injury prevention (ESIP) devices protect against NSIs. To our knowledge, no study has been published to date to demonstrate clinical effectiveness of an intraoperative ESIP device. Operative Armour is a wearable arm cuff that can be donned during surgical closure to allow surgeons to keep a suture pack and sharps protection container on their forearm. Objective We characterize Operative Armour’s ESIP device effectiveness in a tertiary hospital, hypothesizing that this device will decrease NSI risk by decreasing behaviors associated with NSIs: needle passing and handling. Methods A prospective case-control study was conducted with institutional review board quality improvement designation in which authors observed skin closures of plastic surgery procedures. To ensure accuracy, one surgeon was observed at a time. Control surgeries were purely observational; intervention cases involved surgeon use of the device during skin closure. Outcomes of interest included needle passing, needle handling, lost needles, and loaded waiting needles. Results Surgeons were observed in 50 control and 50 intervention cases. Operative Armour eliminated needle passing during skin closure. One NSI occurred in one control case; no NSIs were observed in intervention cases (P=.36). The mean number of loaded and unprotected waiting needles was also significantly decreased in the intervention group from 2.3 to 0.2 (P<.001). Furthermore, a multivariable linear regression established that Operative Armour significantly decreased the number of needle adjustments by hand per stitch observed (F4, 21.68=3.72; P=.01). In fact, needle adjustments by hand decreased overall (1 adjustment per 10 stitches vs 1 adjustment per 5 stitches, P=.004), and adjustments occurred half as frequently with use of Operative Armour in free flap reconstruction (1 adjustment per 10 stitches vs 1 adjustment per 5 stitches, P=.03) and a quarter as frequently in other breast reconstruction cases such as mastopexy (1 adjustment per 20 stitches vs 1 adjustment per 5 stitches, P=.002). Conclusions Operative Armour effectively functions as an ESIP device by decreasing intraoperative needle passing and handling. Although sample size prohibits demonstrating a decrease in NSIs during observed cases, by decreasing behaviors that drive NSI risk, we anticipate an associated decrease in NSIs with use of the device.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».