The Significance of Patient Involvement in Research Design

Reference:  Jain A, et al. Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial. Br J Surg. March 2023 Date: May 7, 2024 Guest Skeptic: Dr. Brian Lee is a pediatric emergency medicine attending at the Children’s Hospital of Philadelphia and Assistant Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. Dr. Brian Lee Case: A 5-year-old girl comes to the emergency department (ED) after smashing her finger with a hammer. Her mother, who possesses a strong “do-it-yourself” attitude, was busy constructing a bookshelf for her daughter when the girl grabbed a hammer to help and promptly dropped it on her finger. On your exam, the girl is tearful and has a bloody index finger, and the fingernail is almost nearly avulsed. She is otherwise uninjured. Her mother tells you, “I remember this happening to me when I was younger, and they had to remove my fingernail. Is there any way to save the fingernail?” Background: Fingertip and nail bed injuries are some of the most common hand injuries in children. These can range from subungual hematomas to lacerations to partial amputations. Fingers and hands are important for performing daily activities, and we want to ensure that these injuries heal appropriately. That includes considerations for function and cosmesis. Some myths have been perpetuated throughout the years regarding finger injuries. For example, the teaching that if a subungual hematoma is >50% of the nail bed, then the nail should be removed because there is likely an underlying nailbed laceration that needs to be repaired. This is not true because we have learned that if the nail is otherwise intact, we can just trephinate it and be done.[1] Another practice that we’ve encountered in fingertip injuries where the nail is avulsed is replacing the nail during the repair. Reasons for that practice include protecting the repair, splitting the nail fold, and reducing infection. But there is not really high-level evidence to back up those claims, and some centers have even advocated for not replacing the nail given the challenges of adequately cleaning the native nail. [2] Suturing nailbeds and suturing avulsed fingernails back on tend to be a bloody mess. This might be the time for the “don’t just do something, stand there” approach [3]. Clinical Question: Is discarding the fingernail during nail bed repair superior to retaining it?  Reference:  Jain A, et al. Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial. Br J Surg. March 2023 Population: Children less than 16 years of age with nail bed injury to a single finger occurring within 48 hours of presentation believed to require surgical repair Exclusion: Infected injury, underlying nail disease, deformity to the injured finger, amputation, loss of nail bed requiring reconstruction, multiple nail bed injuries Intervention: Fingernail replacement after debridement and suturing of the nail bed or fingernail substitute like foil. Comparison: No fingernail replacement. Outcome: Primary Outcome: Co-primary outcomes of surgical site infection at 7-10 days and cosmetic appearance of the nail using the Oxford Fingernail Appearance Score (OFNAS) Secondary Outcomes: Quality of life based on the EuroQol Five Dimensions (EQ-5D-Y), pain at first dressing change, surgical site infection by 4 months, parent assessment of nail appearance at 4 months, cost difference Trial: Multicentre, pragmatic two-arm parallel-group superiority randomized controlled trial Authors’ Conclusions: “After nail bed repair, discarding the fingernail was associated with similar rates of infection and cosmesis ratings as replacement of the fingernail, but was cost saving.” Quality Checklist for Randomized Clinical Trials: