Summary of project/progress /findings:

Objective - to assess the clinical and cost effectiveness of paediatric nail bed repair with fingernail replacement compared to repair without fingernail replacement.

Design - 2-arm parallel group open multicentre superiority randomised controlled trial.

Setting - 20 secondary care hospitals in the United Kingdom.

Participants - 451 children aged below 18 years presenting with a suspected nail bed injury between July 2018 to July 2019, 224 patients allocated to the nail discarded arm, and 227 to the nail replaced arm.

Interventions – participants randomized to either nail bed repair and replacement of fingernail or nail bed repair and fingernail discarded.

Main outcome measures - the co-primary outcomes were surgical site infection at around 7 days following surgery and cosmetic appearance summary score at a minimum of 4 months.

Results – no difference in surgical site infection at around 7 days or cosmetic appearance. The mean total healthcare cost over the four months following surgery was £75 lower for the nail discarded arm than the nail replaced arm (95% confidence interval £30, £124; p<0.001).

Conclusions – Following nail bed repair, discarding the fingernail does not change infection rates or cosmesis, but is less costly

What is the relevance/value of this research to hand surgery:

Provides evidence to stop the practice of replacing the nail following nail bed surgery

If final report, please provide bullet point list of conclusions/important findings

• No difference in infection or cosmetic appearance with either replacing the nail or not following nail bed repair.
• Less costly to discard the nail following repair of nail bed

Please list presentations based on work performed in this study

• C Cooper, J Cook, A Grieg, M Gardiner, R Pinder, A.Jain, D Beard. Patient and public involvement into the design of a Paediatric surgical trial: The NINJA study. 38th Annual Meeting of the Society for Clinical Trials / 4^th International Clinical Trials Methodology Conference. May 7 - 10, 2017 Liverpool, United Kingdom.

Please list publications based on work performed in this study

Abhilash Jain^1 2, Aina V H Greig ³, Amy Jones ¹, Cushla Cooper ¹, Loretta Davies ¹, Akiko Greshon ¹, Heidi Fletcher ¹, Adam Sierakowski ⁴, Melina Dritsaki ¹, Thi Thu An Nguyen ¹, May Ee Png ¹, Jamie R Stokes ⁵, Helen Dakin ⁶, Jonathan A Cook ¹, David J Beard ¹, Matthew D Gardiner ^1 7; NINJA Collaborative .Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial. Br J Surg. 2023 Mar 30;110(4):432-438. (impact factor 8.6)

A Jain, J Stokes, MD Gardiner, A Jones, J Cook, D Beard, C Cooper, A Sierakowski, B Shirkey, S Dupré , RZ Adami, B Baker, M Fleet, D Miles, R Nicholas, A Nicola, A Plonczak, A Sleiwah, G Williams, AVH Greig. The Oxford Finger Nail Appearance Score - a new scoring system for finger nail deformity. JPRAS 2021 Jan;74(1):94-100.

J Stokes, M E Png, A Jain, A V H Greig, B A Shirkey, M Dritsaki, J A Cook. Nail bed INJury Analysis (NINJA): statistical and health economic analysis plan for a randomised controlled trial investigating if the nail plate should be replaced or discarded after nail bed repair in children. Trials. 2020 Oct 7;21(1):833.

A Jain, A Jones, MD Gardiner, C Cooper, A Sierakowski, M Dritsaki, ME Png, J Stokes, B Shirkey, J Cook, D Beard, A Greig. The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial. BMJ Open 2019 Dec 4;9(12):e031552.

Greig, M.D. Gardiner, A. Sierakowski, C. Zweifel, R. Pinder, D. Furniss, J.A. Cook, D. Beard, N. Farrar, C.D. Cooper, A. Jain. Feasibility study to inform a randomized clinical trial of replacing or discarding the nail plate after nail bed repair in children. Br J Surg. 2017 Nov;104(12):1634-1639 (impact factor 5.899)

Please state what additional research this study has/is leading to

NINJA represents a definitive RCT that has provided evidence to support discarding the nail following nail bed repair in children. This trial has demonstrated that large scale trials in paediatric hand trauma are feasible and acceptable to NHS surgeons and patients. Demographic data we have collected during this trial have confirmed that this surgery is common and represents a significant burden on NHS resource and theatre time with the majority of operations performed under general anaesthetic (90%). The range of trauma suggests that the commonest injuries to the nail bed are simple (62%) or stellate (8%) lacerations with overall low infection rates and excellent cosmetic outcomes. There is data to suggest that children may not require formal surgery to explore and repair the nail bed and in our study 2% of children were found not to have had a nail bed injury at the time of surgery suggesting that they underwent an unnecessary operation. Further work should investigate whether surgery is indeed beneficial and results in better outcome than simple dressings. A large scale RCT funded by the NIHR HTA program would be reasonable to answer this question. The benefit to patients and healthcare system are significant in terms of outcome and cost.

Please list any further funding or grant applications (with outcome), which have resulted from the award of this grant

NIHR Research for Patient Benefit (RfPB) Programme: PB-PG-1215-20041

Nail bed Injury Analysis Trial. Chief Investigator

(November 2016)                                                                                £348,637

How has this grant awards helped your career development?

• YES