[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07388823":3,"trial-entities:NCT07388823":112,"trial-summary:NCT07388823":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":46,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":74,"locations":78,"central_contacts":93,"overall_officials":99,"references":100,"see_also_links":111},"NCT07388823","82680","Nailbed Repair for Patients With Nailbed Injuries","Nail Bed Repair RCT","RECRUITING","2030-10-31","2026-07","2026-07-20","2026-06-01","Stanford University","OTHER",false,"This study compares the outcomes of fixing nail bed injuries with nail bed repair versus irrigation and dressing alone. The main question this study aims to answer is \"Does nail bed repair after nail bed injury lead to better outcomes?\"","This study compares two treatment methods for patients with nail bed injuries. The first method is irrigation and dressing. The second method is nail bed repair. Patients will be randomized into one of the two groups and outcomes will be documented in both groups.",[19,20,21],"Nail Bed Injury","Nail Laceration","Nail Plate Disruption",[],"INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},100,"ESTIMATED",[31,36],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Nail Bed Repair","1. Block involved digit with 3cc 1% lidocaine injected subcutaneously over volar and dorsal metacarpophalangeal joint\n2. Apply tourniquet to base of finger if desired\n3. Remove nail using freer\u002Fhemostats\n4. Irrigate wound with at least 500cc normal saline\n5. Repair nail bed laceration with 5-0 chromic or monocryl suture\n6. Stent eponychium with native nail or fashion substitute from foil suture packet and secure with 2 sutures\n7. Dress finger with bacitracin, xeroform, and 2\" kling wrap\n8. Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed)\n9. Repair any other lacerations as needed",[35],"Nail bed repair",{"type":14,"name":37,"description":38,"armGroupLabels":39},"Nail bed dressing","1. If there is a subungual hematoma \\>50% of the nail, trephinate the nail plate using an 18G needle\n2. Irrigate wound with at least 500cc normal saline\n3. Dress finger with bacitracin, xeroform, and 2\" kling wrap\n4. Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed)\n5. Repair any other lacerations as needed",[40],"No nail bed repair (Irrigation and Dressing)",[42],{"measure":43,"description":44,"timeFrame":45},"Oxford Nail Score","The Oxford Nail Score assess five cosmetic components marked as binary outcomes composed of nail shape, nail adherence, eponychial appearance, nail surface appearance and presence of a split. The final score is 0-5, where 0 is \"least optimal appearance\" and 5 is \"most optimal appearance.\"","From time of treatment, outcomes will be measured at 1-2 weeks, 6 months, 1 year, and 2 years",[47,51,54,58],{"measure":48,"description":49,"timeFrame":50},"Subjective Cosmesis","Patients will self-score their cosmesis on a 5-point Likert scale, from \"excellent\" to \"very poor\"","1-2 weeks, 6 months, 1 year, 2 years",{"measure":52,"description":53,"timeFrame":50},"NRS Pain score","Patients will rate their nailbed on a 0-10 scale, where 0 is no pain and 10 is the worst pain imaginable.",{"measure":55,"description":56,"timeFrame":57},"Nail regrowth","Nail regrowth will be documented on a binary scale (yes or no) by an evaulator via photo.","1-2 weeks, 6 weeks, 1 year, 2 years",{"measure":59,"description":60,"timeFrame":50},"Evidence of infection","Evidence of infection will be evaluated on a binary scale (yes or no) by an evaluator via photo.","ALL","2 Years",null,{"inclusion":65,"exclusion":69,"raw_text":73},[66,67,68],"patients 2+ years of age","presenting with disruption of nail plate or laceration adjacent to nail which appears that it may extend into the nail matrix OR subungual hematoma \\>50% of nail","presenting within 3 days of acute injury",[70,71,72],"missing (e.g. avulsed) nail bed or segment of nail bed,","prior injury to affected nail","need for surgical treatment of injury (e.g. underlying operative fracture)","Inclusion Criteria:\n\n* patients 2+ years of age\n* presenting with disruption of nail plate or laceration adjacent to nail which appears that it may extend into the nail matrix OR subungual hematoma \\>50% of nail\n* presenting within 3 days of acute injury\n\nExclusion Criteria:\n\n* missing (e.g. avulsed) nail bed or segment of nail bed,\n* prior injury to affected nail\n* need for surgical treatment of injury (e.g. underlying operative fracture)",[75,76,77],"CHILD","ADULT","OLDER_ADULT",[79],{"facility":13,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":90},"Palo Alto","California","94305","United States",[85,88],{"name":86,"role":87},"Anna Luan, MD","PRINCIPAL_INVESTIGATOR",{"name":89,"role":87},"Rachel Roller, MD",{"lat":91,"lon":92},37.44188,-122.14302,[94],{"name":95,"role":96,"phone":97,"email":98},"Sara Kemper","CONTACT","650 725 7897","sara.kemper@stanford.edu",[],[101,105,108],{"pmid":102,"type":103,"citation":104},"6715836","BACKGROUND","Zook EG, Guy RJ, Russell RC. A study of nail bed injuries: causes, treatment, and prognosis. J Hand Surg Am. 1984 Mar;9(2):247-52. doi: 10.1016\u002Fs0363-5023(84)80153-7.",{"pmid":106,"type":103,"citation":107},"5335262","Ashbell TS, Kleinert HE, Putcha SM, Kutz JE. The deformed finger nail, a frequent result of failure to repair nail bed injuries. J Trauma. 1967 Mar;7(2):177-90. doi: 10.1097\u002F00005373-196703000-00001. No abstract available.",{"pmid":109,"type":103,"citation":110},"35513322","Rao V, Akiki RK, Crozier JW, Bhatt RA, Schmidt ST, Kalliainen LK. Rethinking the Need for Nail Plate Removal: A Comparison of the Risks Between Standard Nail Bed Repair and Nonoperative Management. Ann Plast Surg. 2022 May 1;88(3 Suppl 3):S209-S213. doi: 10.1097\u002FSAP.0000000000003197.",[],{"nct_id":4,"conditions":113,"biomarkers":115},[19,114,21],"Nail bed laceration",[],{"nct_id":4,"found":117,"summary":118,"prompt_version":128},true,{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This study compares two treatment methods. Patients will be randomly assigned to one of the two groups.","completed","Nailbed Repair for Nailbed Injuries","This study is looking at two ways to treat nail bed injuries: either by repairing the nail bed directly, or by simply cleaning and dressing the injury. The main goal is to see if repairing the nail bed leads to better outcomes. You might be able to join if you are at least 2 years old, have a disrupted nail plate, a cut near your nail that might go into the nail matrix (the part that grows the nail), or a large bruise under your nail (subungual hematoma) covering more than half of it. You also need to have had the injury within the last 3 days. We don't know yet if the study is actively looking for participants.","Outcomes will be measured at 1-2 weeks, 6 months, 1 year, and 2 years after treatment.",119,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]