Cost-effectiveness of replacing versus discarding the nail in children with nail bed injury.

Every year in the UK, around 10 000 children need to have operations to mend injuries to the bed of their fingernails. Currently, most children have their fingernail placed back on the injured nail bed after the operation. The NINJA trial found that children were slightly less likely to have an infection if the nail was thrown away rather than being put back, but the difference between groups was small and could have be due to chance. This study looked at whether replacing the nail is cost-effective compared with throwing it away. Using data from the NINJA trial, we compared costs, healthcare use, and quality of life and assessed the cost-effectiveness of replacing the nail. It was found that throwing the nail away after surgery would save the National Health Service (NHS) £75 (€85) per operation compared with placing the nail back on the nail bed. Changing clinical practice could save the NHS in England £720 000 (€819 000) per year.

Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial.

BACKGROUND: Surgery for nail bed injuries in children is common. One of the key surgical decisions is whether to replace the nail plate following nail bed repair. The aim of this RCT was to assess the clinical effectiveness and cost-effectiveness of nail bed repair with fingernail replacement/substitution compared with repair without fingernail replacement. METHODS: A two-arm 1 : 1 parallel-group open multicentre superiority RCT was performed across 20 secondary-care hospitals in the UK. The co-primary outcomes were surgical-site infection at around 7 days after surgery and cosmetic appearance summary score at a minimum of 4 months. RESULTS: Some 451 children presenting with a suspected nail bed injury were recruited between July 2018 and July 2019; 224 were allocated to the nail-discarded arm, and 227 to the nail-replaced arm. There was no difference in the number of surgical-site infections at around 7 days between the two interventions or in cosmetic appearance. The mean total healthcare cost over the 4 months after surgery was €84 (95 per cent c.i. 34 to 140) lower for the nail-discarded arm than the nail-replaced arm (P < 0.001). CONCLUSION: After nail bed repair, discarding the fingernail was associated with similar rates of infection and cosmesis ratings as replacement of the finger nail, but was cost saving. Registration number: ISRCTN44551796 (http://www.controlled-trials.com).

The Oxford Finger Nail Appearance Score - a new scoring system for fingernail deformity following paediatric finger tip trauma.

Fingernail deformity is common, yet current methods used to define cosmetic appearance following trauma are mainly descriptive. In order to quantify the cosmetic appearance of the fingernail, we developed the Oxford Fingernail Appearance Score using a three stage iterative process. The score has five cosmetic components marked as binary outcomes composed of nail shape, nail adherence, eponychial appearance, nail surface appearance and presence of a split. In the first stage, two assessors independently assessed 25 photographs of fingernails taken at a minimum of four months following paediatric nail bed repair and compared them to the corresponding contralateral uninjured finger. Following refinement in the score, ten different assessors scored a further 62 photographs of fingernails taken after paediatric nail bed repair. Assessors completed each of the five components, and the overall component score was calculated by statisticians post-hoc, taking the ideal appearance of each component as 1 ("identical to opposite" for nail shape, eponychium and surface, "complete" for adherence, "absent" for split) and all the non-ideal appearances as 0. Assessors effectively scored the photographs' integer values between 0 (least optimal appearance) and 5 (most optimal appearance). Refinements in the scoring system resulted in an improvement in a weighted kappa statistic of 0.36 (95% CI:0.09,0.68) in the initial score to 0.52 (95% CI: 0.42, 0.61). The Oxford Fingernail Appearance Score is a user-friendly and reliable scoring system which has application in a clinical trial setting.

Should the nail plate be replaced or discarded after nail bed repair in children? Nail bed INJury Analysis (NINJA) randomised controlled trial: a health economic and statistical analysis plan.

BACKGROUND: Nail bed trauma is one of the most common surgically treated paediatric hand injuries in the UK. Despite surgeons generally expressing a preference to replace the nail plate after repairing the nail bed, there is limited evidence to support this practice. We describe a statistical and health economic analysis plan (SHEAP) for the Nail bed INJury Analysis (NINJA) randomised controlled trial. METHODS/DESIGN: NINJA is a multicentre, pragmatic, superiority, parallel group randomised controlled trial of the treatment of nail bed injury in participants 16 years old or younger. The study aims to evaluate the efficacy and cost-effectiveness of replacing the nail plate compared to discarding it following the repair of a nail bed injury. Surgical site infection at 7-10 days post-randomisation and cosmetic appearance of the nail are the co-primary outcomes for NINJA. Surgical site infection at 7-10 days post-randomisation will be evaluated using a logistic regression model adjusting for site as the sole stratification factor and allowing for intra-site correlation. Cosmetic appearance will be assessed via the newly developed Oxford Finger Nail Appearance Score and will be evaluated by use of a Mann-Whitney U test. An ordinal logistic regression model will also be used to assess the Oxford Finger Nail Appearance Score, adjusting for site and allowing for intra-site correlation. Secondary outcomes are measured at 7-10 days and 4 months and include the EQ-5D-Y questionnaire, pain at first dressing change, cost-effectiveness, late surgical site infection, and participant/parent satisfaction with nail healing. Missing primary outcome data will be summarised by treatment arm and investigated through a sensitivity analysis. Full details of the planned methods of analysis and descriptive statistics are described in this paper. The NINJA study protocol has been published previously. DISCUSSION: The planned analysis strategy for the NINJA trial has been set out here to reduce the risk of reporting bias and data-driven analysis. Any deviations from the SHEAP described in this paper will be detailed and justified fully in the final report of the trial. TRIAL REGISTRATION: ISRCTN, ISRCTN44551796 . Registered on 23 April 2018.

NINJA trial: should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multicentre randomised control trial.

INTRODUCTION: Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with increased postoperative infection. We will investigate the impact of replacing or discarding the nail plate on infection, cosmetic appearance, pain and subsequent healthcare use. The Nail bed INJury Analysis trial (NINJA) aims to answer the question of whether the nail plate should be replaced or discarded after surgical nail bed repair in children. METHODS AND ANALYSIS: A two-arm parallel group open multicentre randomised control trial of replacing the nail plate or not, as part of a nail bed repair, will be undertaken in children presenting within 48 hours of a nail bed injury requiring surgical repair. The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery. Secondary outcomes are EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use. We will recruit a minimum of 416 patients (208 in each group) over 3 years. Children and their parents/carers will be reviewed in clinic around 7 days after their operation and will be assessed for surgical site infection or other problems. The children, or depending on age, their parents/carers, will also be asked to complete a questionnaire and send in photos of their fingernail at a minimum of 4 months postsurgery to assess cosmetic appearance. ETHICS AND DISSEMINATION: The South Central Research Ethics Committee approved this study on 4 June 2019 (18/SC/0024). A manuscript to a peer-reviewed journal will be submitted on completion of the trial as per National Institute for Health Research publication policy. The results of this trial will substantially inform clinical practice and provide evidence on whether the practice of replacing the nail plate should continue at the time of nail bed repair. TRIAL REGISTRATION NUMBER: ISRCTN44551796.

Unusual Craniofacial Distraction.

A retrospective Institutional Review Board-approved review was performed at the Institute of Reconstructive Plastic Surgery, NYU Langone Medical Center, of patients undergoing craniofacial distraction osteogenesis procedures using the rigid external distractor device between 2000 and 2010. Three particularly challenging cases were identified and are presented here.

Prospective randomized controlled trial: fibrin sealant reduces split skin graft donor-site pain.

BACKGROUND: Pain at split skin graft donor sites is common. Fibrin sealant has been demonstrated to reduce time to hemostasis at wound sites, and patients receiving this treatment were incidentally noted to report less pain. This study aimed to evaluate pain and incapacity in split skin graft donor sites treated with and without fibrin sealant. METHODS: Fifty patients requiring thigh donor-site split skin grafts were prospectively randomized to receive either a self-adhesive fabric dressing alone or fibrin sealant plus the self-adhesive fabric dressing as primary donor-site dressings. External secondary dressings were the same. Patients were blinded with regard to treatment group. Using visual analogue scales (scored 0 to 5), patients rated their donor-site pain and incapacity for 14 days postoperatively. Secondary endpoints were length of hospital stay and duration of requirement for dressings. RESULTS: Forty patients were included in the study analysis and completed self-reported pain and incapacity scores. Twenty received the fibrin sealant plus self-adhesive fabric dressing and 20 received the fabric dressing only (controls). Patients using the fibrin sealant plus the dressing reported significantly less pain (mean score, 0.42 versus 1.60, p < 0.001) and significantly less incapacity (mean score, 0.48 versus 1.71, p < 0.001). Patients allocated to the fibrin sealant group recorded shorter lengths of stay and faster time to discontinuation of dressing, though statistical significance was not achieved. CONCLUSION: Patients whose split skin graft donor sites were dressed with fibrin sealant plus self-adhesive fabric dressing experienced significantly less pain and incapacity than patients with self-adhesive fabric dressings alone, allowing a more rapid return to normal activity. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Correcting the typical Apert face: combining bipartition with monobloc distraction.

BACKGROUND: Bipartition distraction is a novel procedure combining frontofacial bipartition and monobloc distraction. Apert syndrome and other syndromic craniofacial dysostoses are often characterized by hypertelorism, with a negative canthal axis and counterrotated orbits. Central midface hypoplasia can result in a biconcave face in both midsagittal and axial planes. Bipartition distraction can correct these facial abnormalities. METHODS: Twenty patients (19 Apert syndrome patients and one Pfeiffer syndrome patient, aged 1.6 to 21 years) underwent bipartition distraction. Severity of appearance was graded preoperatively and postoperatively as mild, moderate, or severe. Functional problems were documented by a multidisciplinary team. Central and lateral midface skeletal advancement were measured. Follow-up ranged from 15 months to 7 years. RESULTS: Bipartition distraction consistently produced more central than lateral facial advancement. Mean central advancement was 13.2 ± 5.9 mm at sella-nasion and 11.7 ± 5.4 mm at sella-A point. Lateral advancement was 4.7 ± 2.8 mm. Unbending the face improved aesthetic appearance. Airway function, eye exposure, and elevated intracranial pressure were improved. Complications included six temporary cerebrospinal fluid leaks (four needing a lumbar drain), five patients with postoperative seizures, five patients requiring Rigid External Distraction frame repositioning, one palatal fistula, one velopharyngeal incompetence, five pin-site infections, one abscess under frontal bone, three cases of sepsis, nine patients with worsened strabismus, two patients with enophthalmos, one patient with partial visual field loss, and three patients who required reintubation because of aspiration. CONCLUSIONS: : Bipartition distraction is an effective procedure with which to differentially advance the central face in Apert syndrome. It improves both function and aesthetics. CLINICAL QUESTION/LEVEL OF EVIDENCE: : Therapeutic, IV.

Pfeiffer syndrome: analysis of a clinical series and development of a classification system.

Among the craniosynostosis syndromes, Pfeiffer syndrome is notable because of high mortality and the need for multiple surgical interventions. However, it is variable in severity. We propose a new classification of Pfeiffer Syndrome to define pathology and function. A retrospective review was conducted of 42 patients with Pfeiffer syndrome treated from 1975 to 2010, the largest series reported to date. The classification was based on a functional assessment of patients in terms of respiratory, ocular, otological, and neurological status. This classification was tested by scoring and stratifying patients as follows: type A (mild problems), B (moderate problems), or C (severe problems). Patients were scored both at the time of presentation and after all surgical interventions to assess change in functional outcome. The functional classification system was compared to another previously reported. Type A patients did not have any change in postoperative functional outcomes (mean preoperative score 1.6, mean postoperative score 1.6); type B patients showed functional improvement (mean preoperative score 4.1, mean postoperative score 3.4) but type C patients (mean preoperative score 7.7, mean postoperative score 4.8) demonstrated the greatest improvement in functional scores after surgical intervention. Suture pathology did not indicate the clinical severity of phenotype, a variance from a previously published classification. The proposed classification is useful to assess severity of phenotype: respiratory, ocular, otologic, and neurologic problems are key indicators of the need for treatment. The classification can provide a helpful guide in multidisciplinary treatment planning, in reporting outcomes, and in the sharing of data among craniofacial anomalies centers.

Purinergic signaling in healthy and diseased skin.

Adenosine 5'-triphosphate and adenosine receptors have been identified in adult and fetal keratinocytes, fibroblasts, melanocytes, mast cells, Langerhans cells, and Meissner's corpuscles, as well as in hair follicles, sweat glands, and smooth muscle and endothelial cells of skin vessels. Purinergic signaling is involved in skin pathology, including inflammation, wound healing, pain, psoriasis, scleroderma, warts, and skin cancer.

The evolution of mandibular distraction: device selection.

BACKGROUND: Mandibular distraction has evolved from the use of external to the use of intraoral and semiburied devices. The authors highlight the evolution of the semiburied technique. The authors evaluate advantages and limitations, and report perioperative events for external and semiburied techniques to establish the indications for selection of the different devices. METHODS: A retrospective review was conducted of patients undergoing mandibular distraction at the New York University Langone Medical Center from the authors' introduction of mandibular distraction in May of 1989 to June 30, 2009. Perioperative events were stratified into three groups: minor incidents, moderate incidents, and major incidents. RESULTS: A total of 211 mandibular distraction procedures were performed: 129 external procedures on native bone, 37 external procedures on grafted bone, and 45 semiburied procedures on native bone. Minor incidents were more common with the semiburied device (62 percent) compared with external devices on native (26 percent) and grafted (38 percent) bone. There were fewer moderate incidents with the semiburied device (18 percent) than with the external device on native (22 percent) and grafted (30 percent) bone. In contrast to the external technique, no major incidents were seen with semiburied distraction. CONCLUSIONS: The semiburied device reduces scarring and has the mechanical advantages of being applied directly to the bone, less vulnerable to dislodgment, and more favorable for a vertical vector. However, its use requires more bone stock and it has the disadvantage of requiring a second operation for removal. Semiburied distraction is safe, reliable, and indicated for lengthening of the hypoplastic mandible where there is adequate bone stock for its attachment.

Giant hemifacial plexiform neurofibroma arising from trigeminal ganglion.

We present a case of a massive hemifacial plexiform neurofibroma. The tumor arose from the right trigeminal ganglion in the middle cranial fossa, involving the 3 divisions of the trigeminal nerve. This affected the whole right side of the face. The principles of management are discussed.

Purinergic receptors are part of a signalling system for proliferation and differentiation in distinct cell lineages in human anagen hair follicles.

We investigated the expression of P2X(5), P2X(7), P2Y(1) and P2Y(2) receptor subtypes in adult human anagen hair follicles and in relation to markers of proliferation [proliferating cell nuclear antigen (PCNA) and Ki-67], keratinocyte differentiation (involucrin) and apoptosis (anticaspase-3). Using immunohistochemistry, we showed that P2X(5), P2Y(1) and P2Y(2) receptors were expressed in spatially distinct zones of the anagen hair follicle: P2Y(1) receptors in the outer root sheath and bulb, P2X(5) receptors in the inner and outer root sheaths and medulla and P2Y(2) receptors in living cells at the edge of the cortex/medulla. P2X(7) receptors were not expressed. Colocalisation experiments suggested different functional roles for these receptors: P2Y(1) receptors were associated with bulb and outer root sheath keratinocyte proliferation, P2X(5) receptors were associated with differentiation of cells of the medulla and inner root sheaths and P2Y(2) receptors were associated with early differentiated cells in the cortex/medulla that contribute to the formation of the hair shaft. The therapeutic potential of purinergic agonists and antagonists for controlling hair growth is discussed.

Choice of flap for the management of deep sternal wound infection--an anatomical classification.

BACKGROUND: Infection of a median sternotomy wound is a rare albeit potentially fatal complication because of the risk of mediastinitis and deep sternal wound infection. Current treatment of deep sternal wound infection comprises antibiotics, debridement and transposition of muscle or omental flaps to fill the anterior mediastinal dead space. METHODS: A retrospective analysis of the deep sternal wound infections treated in our unit over a nine-year period was performed. RESULTS: Out of the 11 903 consecutive coronary artery bypass graft procedures performed, 27 patients were referred to plastic surgery for management of deep sternal wound infection with flaps. Wounds were classified based on their location on the sternum as type A (upper (1/2)), B (lower (1/2)) or C (whole of sternum). Five patients had type A wounds, 12 type B wounds and 10 type C wounds. The mean age was 68 years and the M:F ratio was 20:7. We describe guidelines for the choice of flap for sternal wound reconstruction, according to the anatomical site of the wound dehiscence.

P2X(5) and P2X(7) receptors in human warts and CIN-612 organotypic raft cultures of human papillomavirus infected keratinocytes.

Purinergic receptors, which bind adenosine 5'-triphosphate (ATP), are expressed on human cutaneous keratinocytes and in squamous cell carcinomas. Studies on normal human epidermis and primary keratinocyte cultures have suggested that P2X(5) receptors are likely to be involved in keratinocyte differentiation and P2X(7) receptors are likely to be part of the machinery of end stage terminal differentiation/apoptosis of keratinocytes. P2X(7) receptor agonists can significantly reduce primary keratinocyte cell numbers in culture. Human papillomaviruses are increasingly recognised as important human carcinogens in the development of non-melanoma skin cancers. In our study, immunohistochemical analysis for P2X(5) and P2X(7) receptors was performed on paraffin sections of normal human skin, warts, raft cultures of normal human keratinocytes and raft cultures of CIN 612 cells, a model of keratinocytes infected with human papillomavirus type 31. In warts there was up-regulation of the expression of P2X(5) receptors. A similar pattern was seen in the CIN 612 raft cultures. Both P2X(5) and P2X(7) receptors were found in the nuclei of koilocytes, abnormal keratinocytes characteristic of human papillomavirus infection. P2X(5) and P2X(7) receptors may provide a new focus for therapeutic research into treatments for warts because these receptors can induce cell differentiation and cell death.

Expression of purinergic receptors in non-melanoma skin cancers and their functional roles in A431 cells.

We investigated the use of purinergic receptors as a new treatment modality for nonmelanoma skin cancers. Purinergic receptors, which bind adenosine 5'-tri-phosphate, are expressed on human cutaneous keratinocytes. Previous work in rat and human epidermis suggested functional roles for purinergic receptors in the regulation of proliferation, differentiation, and apoptosis. Immunohistochemical analysis of frozen sections in human basal cell carcinomas and squamous cell carcinomas for P2X5, P2X7, P2Y1, P2Y2, and P2Y4 receptors was performed, accompanied by detailed analysis of archive material of tumor subtypes in paraffin sections. Functional studies were performed using a human cutaneous squamous cell carcinoma cell line (A431), where purinergic receptor subtype agonists were applied to cells and changes in cell number were quantified via a colorimetric assay. Immunostaining in paraffin sections was essentially the same as that in frozen sections, although more detail of the subcellular composition was visible. P2X5 and P2Y2 receptors were heavily expressed in basal cell carcinomas and squamous cell carcinomas. P2X7 receptors were expressed in the necrotic center of nodular basal cell carcinomas and in apoptotic cells in superficial multifocal and infiltrative basal cell carcinomas, and squamous cell carcinomas. P2Y1 receptors were only expressed in the stroma surrounding tumors. P2Y4 receptors were found in basal cell carcinomas but not in squamous cell carcinomas. P2X5 receptors appear to be associated with differentiation. The P2X7 receptor agonist benzoylbenzoyl-adenosine 5'-triphosphate and high concentrations of adenosine 5'-triphosphate (1000-5000 microM) caused a significant reduction in A431 cell number (p<0.001), whereas the P2Y2 receptor agonist uridine 5'-triphosphate caused a significant amount of proliferation (p<0.001). We have demonstrated that non-melanoma skin cancers express functional purinergic receptors and that P2X7 receptor agonists significantly reduce cell numbers in vitro.