Validity of the Cleft Aesthetic Rating Scale Does Not Improve with Inclusion of Fixed Scores for Atypical Outcomes.

OBJECTIVE: The Cleft Aesthetic Rating Scale (CARS) is a valid tool to assess the aesthetic outcome after unilateral cleft lip and palate (UCLP) repair. The goal of this study was to investigate whether the reliability of CARS increases by including fixed rates for atypical outcomes such as a smaller nostril, lower vermillion border or whistling deformity. DESIGN: 197 patients with UCLP who underwent cleft repair were included. Three cleft experts rated the post-operative photos using the original CARS, followed by a second assessment employing the modified CARS. SETTING: Medisch Centrum Leeuwarden, Universitair Medisch Centrum Groningen, Radboud Universitair Medisch Centrum and Amsterdam University Medical Center. PATIENTS: Photographs of 16- to 25-year-old patients with repaired UCLP. INTERVENTIONS: Two separate assessments using the original and modified CARS. MAIN OUTCOME MEASURES: The Intraclass Correlation Coefficient (ICC) was used to test inter-rater reliability of the original and modified version of the CARS. RESULTS: The reported ICC for the nose scored by means of the original and modified CARS were 0.68 (95% CI 0.62-0.74) and 0.66 (95% CI 0.59-0.72) respectively. The reported ICC for the lip assessed with the original and modified CARS were 0.53 (95% CI 0.33-0.67) and 0.57 (95% CI 0.34-0.72) respectively. CONCLUSIONS: No significant difference was found between the original and modified ICC of the nose and lip. The implementation of the fixed rates did not result in an increased reliability of the CARS. Therefore, we recommend the utilization of the original CARS.

A clinimetric assessment of the validity and reliability of 3D technology for scar surface area measurement.

INTRODUCTION: The quality of scars has become an important outcome of burn care. Objective scar assessment through scar surface area measurement enables quantification of scar formation and evaluation of treatment efficacy. 3D technology has proven valid and reliable but often remains cumbersome, expensive, and time-consuming. 3D technology with depth sensors on mobile devices has become available and might surpass these limitations. This study provides a clinimetric assessment of the validity and reliability of a 3D system with a depth sensor for scar surface area measurement. METHODS: A technology involving a depth sensor mounted on a mobile device was used. Images and analyses were made with a custom-made software application. A standardized one-keyframe image capturing procedure was followed. To assess validity, stickers with predefined dimensions (8.01 cm2 - 77.70 cm2) were imaged in a single observer setting on various body parts of healthy volunteers. To assess reliability, hypertrophic scars, keloids, and normotrophic scars were imaged and rated by two observers independently. Data are expressed as mean (+/-SD), Coefficient of Variation (CV), Intraclass Correlation Coefficients (ICC), and Limits of Agreements (LoA). RESULTS: Eighty stickers placed on 20 healthy volunteers showed validity with CV between 0.62%- 1.67% for observer A and 0.75%- 1.19% for observer B. For the reliability study, 69 scars on 36 patients were included. Mean scar surface area ranged from 0.83 cm2 to 155.59 cm2. Mean scar surface area measurement was 13.83 cm2 (SD 23.06) for observer A and 13.59 cm2 (SD 23.31) for observer B. Adjusted interobserver CV for trained observers is estimated as 5.59%, with corresponding LoA = 0 ± 0.15 x mean surface area. Interobserver ICCs were 0.99-1.00. CONCLUSION: This 3D technology with a depth sensor for measuring scar surface area provides valid and reliable data and thereby surpasses expensive and time-consuming 3D cameras.

The effect of explantation on systemic disease symptoms and quality of life in patients with breast implant illness: a prospective cohort study.

Silicone breast implants (SBIs) have been subject to scientific scrutiny since the 1960's because of their potential link with systemic disease symptoms. Breast implant illness (BII) is a cluster of over 56 (systemic) symptoms attributed by patients to their SBIs. BII remains an unofficial medical diagnosis, although its symptoms include but are not limited to the clinical manifestations of autoimmune/inflammatory syndrome induced by adjuvants (ASIA). The aim of this study was to prospectively analyse the effect of explantation on clinical manifestations of ASIA/BII symptoms, as well as to compare (breast-surgery specific) QoL in patients pre- and postoperatively while recording relevant perioperative/patient data. A prospective cohort study was conducted on 140 patients consulting a single surgeon for explantation of SBIs at a single clinic from 2019 to 2021 via their general practitioner, a medical specialist or self-referral. Of all patients, medical (implant) history, lifestyle factors and biometric data were obtained. Patients filled out a novel ASIA/BII symptom-survey termed the ASIA-scale, three domains of the SF-36 and the augmentation module of the BREAST-Q before and four months after the operation. A total of 109 patients completed both the pre- and postoperative survey with a mean follow-up duration of 205 days. There was a significant decrease in all individual symptom scores as well as ASIA-scale summary scores after explantation (p < .001). All SF-36 subdomains showed significant improvement postoperatively (p < .001). The BREAST-Q subdomain 'satisfaction with breasts' improved significantly after explantation (p = .036). No statistically significant association was found between any clinical parameters (such as age, capsulectomy, rupture etc.) and the recovery of symptom scores. This is the largest prospective cohort study on SBI explantation to date showing significant improvement of the most common systemic complaints in SBI patients as well as improvement of satisfaction with breasts and overall quality of life.

The Aetiopathogenesis of Late Inflammatory Reactions (LIRs) After Soft Tissue Filler Use: A Systematic Review of the Literature.

BACKGROUND: Late inflammatory reactions (LIRs) are the most challenging complications after filler use. The immune system plays a prominent role in its etiology, albeit to an unknown extent. Bacterial contamination in situ has been hypothesized to be causative for LIRs. How this relates to the immunological processes involved is unknown. This article aims to provide an overview of immunological and bacterial factors involved in development of LIRs. METHODS: We undertook a systematic literature review focused on immunological factors and microbiota in relation to LIRs after filler use. This systematic review was performed in accordance with the PRISMA guidelines. PubMed, EMBASE and the Cochrane databases were searched from inception up to August 2019. Included studies were assessed for the following variables: subject characteristics, number of patients, primary indication for filler injection, implant type/amount and injection site, type of complication, follow-up or injection duration, study methods, type of antibiotics or medical therapies and outcomes related to microbiota and immunological factors. RESULTS: Data on immunological factors and bacterial contamination were retrieved from 21 included studies. Notably, the presence of histocytes, giant cells and Staphylococcus epidermidis within biopsies were often associated with LIRs. CONCLUSION: This review provides a clear overview of the immunological factors associated with LIRs and provides a hypothetical immunological model for development of the disease. Furthermore, an overview of bacterial contamination and associations with LIRs has been provided. Follow-up research may result in clinical recommendations to prevent LIRs. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors- www.springer.com/00266. .

Hypertrophic and keloid scars fail to progress from the CD34- /α-smooth muscle actin (α-SMA)+ immature scar phenotype and show gradient differences in α-SMA and p16 expression.

BACKGROUND: Our understanding of the pathogenesis underlying keloid scar formation is still very limited, and the morphological distinction between hypertrophic and keloid scars remains difficult. OBJECTIVES: To test whether hypertrophic and keloid scars may reflect an inability to progress from immaturity to the desired mature normotrophic scar phenotype. METHODS: Using whole-biopsy imaging and an objectively quantifiable way to analyse immunoreactivity, we have compared the immunohistopathological profiles of young immature scars with mature normotrophic scars, hypertrophic scars, and keloids with their surrounding-normal-skin. RESULTS: Abnormal scars (hypertrophic scars and keloids) maintain the immature scar phenotype, characterized by a CD34- (tumour biomarker) and α-smooth muscle actin (α-SMA)+ (myofibroblast) dermal region. This is in contrast to normal skin, surrounding-normal-skin and mature normotrophic scars that were CD34+ / α-SMA- . Immature, hypertrophic and keloid scars showed abnormal epidermal differentiation (involucrin), but only hypertrophic scars and keloids showed increased epidermal thickness. Immature scars did show increased epidermal and dermal proliferation (Ki67), which was absent from abnormal scars, where mesenchymal hypercellularity (vimentin) and senescence (p16) were predominant. Keloidal collagen and α-SMA were previously considered to distinguish between hypertrophic scars and keloids. However, α-SMA staining was present in both abnormal scar types, while keloidal collagen was present mostly in keloids. There were no obvious signs of heterogeneity within keloid scars, and the surrounding-normal-skin resembled normal skin. CONCLUSIONS: Both abnormal scar types showed a unique CD34- /α-SMA+ /p16+ scar phenotype, but the differences between hypertrophic scars and keloids observed in this study were of a gradient rather than absolute nature. This suggests that scar progression to the mature normal scar phenotype is, for as yet unknown reasons, hindered in hypertrophic and keloid scars. What's already known about this topic? Hypertrophic and keloid scars both have sustained epidermal barrier dysfunction, suggesting the persistence of an immature scar phenotype. Morphological distinction between hypertrophic and keloid scars remains a topic of debate, although α-smooth muscle actin (α-SMA) and keloidal collagen have been considered distinguishing features of hypertrophic and keloid scars, respectively. It has been suggested that keloids are not simply homogeneous growths, as heterogeneity within keloid scars and possible involvement of the surrounding-normal-skin have been reported. What does this study add? An extensive whole-biopsy imaging and quantifiable immunohistochemical assessment of immature, mature normal, hypertrophic and keloid scars, including normal skin surrounding keloids. Hypertrophic and keloid scars maintain dermal characteristics of immature scars, rather than transitioning into the normal mature phenotype. Differences between hypertrophic and keloid scars were of a gradient rather than absolute nature, with keloids showing the more extreme phenotype. There was no obvious heterogeneity within keloids, and the normal skin surrounding keloids resembled normal skin. What is the translational message? Keloids remain primarily a clinical diagnosis. A raised scar with the CD34- /α-SMA+ /p16+ phenotype with strong immunoreactivity for p16 and significant amounts of keloidal collagen, together with a thickened and strongly abnormal involucrin-stained epidermis, would sway the diagnosis towards keloid scars. A hypertrophic scar seems more likely when the CD34- /α-SMA+ /p16+ phenotype shows very strong presence of α-SMA+ in large dermal nodules, with lesser p16 staining and absent or negligible keloidal collagen.

Toll-Like Receptors (TLRs) Expression in Contracted Capsules Compared to Uncontracted Capsules.

INTRODUCTION: The etiology of capsular contracture after surgical implantation of breast implants remains unclear, but an important role is seen for the immune system. Toll-like receptors are immune receptors recognizing both pathogen-associated molecular patterns and damage-associated molecular patterns. The former are present on bacteria such as Staphylococcus epidermidis (bacteria earlier associated with capsular contracture), and the latter are released after (mechanical) stress. The aim of this study was to investigate the expression of TLRs 1-10 in relation to capsular contracture. MATERIALS AND METHODS: Fifty consecutive breast capsules were collected during implant removal or replacement. The extent of capsular contracture was scored according to the Baker score. A sample specimen (0.5 cm3) was obtained from all tissues. cDNA was synthesized from isolated mRNA from the collected specimens. PCR analyses were conducted to test for cDNA presence and to quantify concentration. TLR1-10 expression was measured for each of the Baker scores separately and compared to all Baker scores. RESULTS: Expression of all TLRs in all Baker scores was seen. TLR2 and TLR6 were more often present in contracted samples (Baker 3 or 4) compared to uncontracted samples (Baker 1 or 2) [Baker 2 vs. 3 (p = 0.034) and Baker 2 vs. 3 (p = 0.003), respectively]. None of the TLRs displayed a significantly higher expression in contracted capsules compared to uncontracted capsules. CONCLUSION: This study shows that TLR2 and TLR6 are more often expressed in contracted capsules compared to non-contracted capsules however not in higher concentrations. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Poly Implant Prothèse silicone breast implants: implant dynamics and capsular contracture.

BACKGROUND: The Poly Implant Prothèse (PIP) implants were withdrawn from the market in 2010 due to the use of low-grade silicone, causing a high risk for implant rupture. The aim of this study was to investigate the implant dynamics of PIP breast implants, as well as to determine the rate and predictors of implant gel bleeding, rupture, and capsular contracture in PIP implants. METHODS: Eighty women with a total of 152 PIP implants who underwent a reoperation in 2012 were enrolled in this study. Physical investigation included assessing the Baker score and demographics were retrospectively traced in medical records. The pre- and post-operative volumes of the implants were calculated and their state was determined intraoperatively by the surgeon. RESULTS: The implants were removed after a mean implant duration of 11 ± 2.1 years. Gel bleed and implant rupture occurred in respectively 42 and 25% of the implants. Intact implants had post-operative volume increase as well as decrease. There was a correlation between gel bleeding and more post-operative implant volume increase (P ≤ 0.05). Capsular contracture had a protective effect against post-operative implant volume increase (P ≤ 0.05), while a post-operative implant volume increase provided a protective influence in developing capsular contracture (P ≤ 0.05). Additionally, implant rupture led to a higher risk of capsular contracture (P ≤ 0.05). CONCLUSIONS: We managed to illustrate that PIP implant shells were too permeable and that there is a correlation between gel bleeding and the increase of the post-operative implant volume. Implant rupture led to a higher risk for developing capsular contracture.Level of evidence: Level III, risk / prognostic study.

The Histological Composition of Capsular Contracture Focussed on the Inner Layer of the Capsule: An Intra-Donor Baker-I Versus Baker-IV Comparison.

BACKGROUND: Capsular contracture remains one of the major complications after breast implantation surgery. The extent of capsular contraction is scored using the Baker scale. The aim of this study was to compare intra-individual Baker-I with Baker-IV capsules, and in particular the prevalence and histological properties of the inner capsule layer. METHODS: Twenty capsules from ten patients were included after bilateral explantation surgery due to unilateral capsular contracture (Baker-IV) after cosmetic augmentation with textured implants. All capsules underwent (immune-)histochemical analysis: haematoxylin-eosin (morphology), CD68 (macrophages), cytokeratin (epithelial cells) and vimentin (fibroblasts), and were visually scored for cell density and the presence of an inner layer and measured for thickness. RESULTS: Baker-IV (n = 10) capsules were significantly thicker compared to Baker-I (n = 10) capsules (P = 0.004). An inner layer was present in 8 Baker-I capsules. All Baker-I capsules were vimentin and CD68-positive and cytokeratin-negative. Positive vimentin was seen throughout the inner layer, and CD-68 staining was observed adjacent to the intermediate capsule layer. In contrast, only 2 Baker-IV capsules had an inner layer, of which only 1 showed the same profile as Baker-I capsules (P = 0.016). No cytokeratin positivity was seen in any capsule. In Baker-IV capsules, outer layers showed more positivity for both vimentin and CD68. CONCLUSION: The inner layer is morphologically consistent with synovial metaplasia and is more prevalent in healthy, uncontracted Baker-I capsules. This inverse relation between the presence of the inner layer and higher Baker classification or pathological contracture could indicate a protective role of the inner layer against capsular contracture formation. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Investigating histological aspects of scars in children.

OBJECTIVE: Very little is known about histological aspects of paediatric scars and the possible role of the immune system during their formation. In this study, the histology thoracic scars caused by the placement of an implantable central venous access device in children who underwent treatment for cancer was assessed. METHOD: The amount and type of collagen, the collagen orientation, the type of elastic fibres, the vascularsation, and the count of neutrophils, macrophages, and lymphocytes were analysed. The severity of scarring was assessed using the Vancouver scar scale (VSS). To evaluate the role of the immune system on scar severity and histology, the scars of children suffering from acute lymphoblastic leukaemia (ALL) were compared with the scars of children suffering from other types of childhood cancer. RESULTS: Our results showed an extremely random orientation of the collagen fibres of the paediatric scars with a mean collagen orientation index of 0.22 (standard deviation (SD) 0.10, zero indicating a perfectly random orientation and a perfectly parallel orientation). A lower collagen orientation index was seen in scars with a lower VSS score (VSS score <3: 0.19 versus VSS score ≥3 0.29, p=0.037). A higher total VSS score, resembling a worse scar, was assessed to the scars in the non-ALL group compared with the children with ALL (mean ALL: 0.91 (0-3) versus mean non-ALL: 2.50 (0-6), p=0.037). CONCLUSION: To our knowledge, this is the first study investigating a wide array of histological aspects in paediatric scars. Compared with adult scars, an extremely random collagen orientation was found (0.22 in children versus 0.41 and 0.46 adult normotrophic and hypertrophic scars, respectively). A lower collagen orientation index was found in scars with a lower VSS score. In addition, less severe scarring was measured in children suffering from ALL compared with children suffering from other types of childhood cancer. This suggests that the immune system could play a role in the development of aberrant scarring and should be a target for future research.

Increased epidermal thickness and abnormal epidermal differentiation in keloid scars.

BACKGROUND: The pathogenesis underlying keloid formation is still poorly understood. Research has focused mostly on dermal abnormalities, while the epidermis has not yet been studied. OBJECTIVES: To identify differences within the epidermis of mature keloid scars compared with normal skin and mature normotrophic and hypertrophic scars. METHODS: Rete ridge formation and epidermal thickness were evaluated in tissue sections. Epidermal proliferation was assessed using immunohistochemistry (Ki67, keratins 6, 16 and 17) and with an in vitro proliferation assay. Epidermal differentiation was evaluated using immunohistochemistry (keratin 10, involucrin, loricrin, filaggrin, SPRR2, SKALP), reverse-transcriptase polymerase chain reaction (involucrin) and transmission electron microscopy (stratum corneum). RESULTS: All scars showed flattening of the epidermis. A trend of increasing epidermal thickness correlating to increasing scar abnormality was observed when comparing normal skin, normotrophic scars, hypertrophic scars and keloids. No difference in epidermal proliferation was observed. Only the early differentiation marker involucrin showed abnormal expression in scars. Involucrin was restricted to the granular layer in healthy skin, but showed panepidermal expression in keloids. Normotrophic scars expressed involucrin in the granular and upper spinous layers, while hypertrophic scars resembled normotrophic scars or keloids. Abnormal differentiation was associated with ultrastructural disorganization of the stratum corneum in keloids compared with normal skin. CONCLUSIONS: Keloids showed increased epidermal thickness compared with normal skin and normotrophic and hypertrophic scars. This was not due to hyperproliferation, but possibly caused by abnormal early terminal differentiation, which affects stratum corneum formation. Our findings indicate that the epidermis is associated with keloid pathogenesis and identify involucrin as a potential diagnostic marker for abnormal scarring.

Currently known risk factors for hypertrophic skin scarring: A review.

OBJECTIVE: The study aims to provide an overview of risk factors for hypertrophic scarring. BACKGROUND: Hypertrophic skin scarring remains a major concern in medicine and causes considerable morbidity. Despite extensive research on this topic, the precise mechanism of excessive scarring is still unknown. In addition, the current literature lacks an overview of the possible risk factors in the development of hypertrophic scars. METHODS: PubMed searches were performed on risk factors for hypertrophic scar (HTS) formation. RESULTS: Eleven studies suggesting nine factors associated with HTS formation were found. Studies concerning chemotherapy, age, stretch, infection, and smoking have a moderate to high strength of evidence, but some other factors have not been studied in a convincing manner or are still disputed. CONCLUSIONS: Risk factors for HTS formation are young age, bacterial colonization, and skin subjected to stretch. Chemotherapy, statins, and smoking seem to play a protective role in HTS formation.

Implementing Real-Time Video Consultation in Plastic Surgery.

BACKGROUND: The Dutch government, hospitals, and health insurance companies have agreed on concentrating all specialist care in a few expert centers. This should lead to lower healthcare costs, but might also cause less accessible healthcare for patients living at a considerable distance from expert centers. A way to overcome less accessible healthcare, while maintaining reduced costs of medical care, is by using telemedicine between physician and patient. METHODS: In a randomized controlled trial, follow-up consultation between the patient and physician via a secured real-time video connection 6 weeks after plastic surgery of the face was compared to traditional in-person consultation after the same time interval. After the consultation, patients received an invite to fill in an online survey, which consisted of questionnaires assessing patient satisfaction (PSQ-18, TSQ) and communication experiences (PEQ), as well as questions about the time spent on different aspects of the consultations. RESULTS: Thirty-one patients participated. Overall satisfaction was equal for both groups, but a significant difference in the dimensions 'general satisfaction' (online consultation group more satisfied) and 'accessibility and convenience' (online consultation group less satisfied) was found. Patients reported significantly lower satisfaction in patient-physician communication in online consultation than in traditional in-person consultations. Patients were satisfied with the online consultation, and were willing to use the system again. Patients in the online consultation group experienced significantly less waiting time, and spent less time in total for the appointment. CONCLUSIONS: Overall patients are equally satisfied with traditional consultation or real-time video consultation in plastic surgery. Online consultation is found to be a time-saving alternative to traditional consultation. However, online consultation is perceived by some patients as a negative influence on communication with the physician. Dedicated training for physicians in the use of online consultation is recommended to improve their online communicative skills. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Asher-McDade Aesthetic Index in Comparison With Two Scoring Systems in Nonsyndromic Complete Unilateral Cleft Lip and Palate Patients.

OBJECTIVE: To compare the Asher-McDade aesthetic index with 2 systems used to score the appearance of the nasolabial area in patients with a complete cleft lip and palate. DESIGN: Retrospective analysis of the results of complete unilateral cleft lip and palate patients. SETTING: Academic Center for Dentistry of Amsterdam and the VU University Medical Center. PATIENTS: Six-year-olds with complete unilateral cleft lip and palate. MAIN OUTCOME MEASURES: Cleft lip and palate patients assessed using the scoring system proposed by Prahl et al, a 5-point ordinal scale, and the scoring system proposed by Asher-McDade et al by 6 judges, 3 orthodontists, and 3 plastic surgeons. A calculation of intra- and interobserver reliability was made. A comparison was made of all the assessment methods using Kendalls' tau. RESULTS: Photographs of 55 children (38 boys and 17 girls) with complete unilateral cleft lip and palate were assessed. For the scoring system of Prahl et al, interobserver reliability varied from 0.43 to 0.53, for the 5-point scale between 0.45 and 0.57, and for the scoring system by Asher-McDade et al these varied between 0.52 and 0.66. Multiple significant correlations were found between the used scoring systems. CONCLUSION: It can be concluded that the Asher-McDade aesthetic index is still superior to the other scoring systems used in this study. However, all 3 scoring systems can reliably be used when 3 or more observers are used.

Comparison of two devices for the treatment of keloid scars with the use of intralesional cryotherapy: An experimental study.

BACKGROUND: Intralesional (IL) cryotherapy is a new technique for the treatment of keloid scars, in which the scar is frozen from inside. Two cryodevices are available, which were recently evaluated. Both devices showed promising results, but differed in clinical outcome. To explain these differences, more understanding of the working mechanism of both devices is required. OBJECTIVE: This experimental study was designed to investigate and compare the thermal behavior of an argon gas- and a liquid nitrogen-based device. Thermal behavior constitutes: (1) minimum tissue temperature (°C), (2) the freezing rate (°C/min). The thermal behavior was measured inside and on the outer surface of the scar. Both devices were tested ex vivo and in vivo. RESULTS: Ex vivo, when determining the maximum freezing capacity, the argon gas device showed a higher end temperature compared to the liquid nitrogen device (argon gas: -120°C, liquid nitrogen: -140°C) and a faster freezing rate (argon gas: -1300°C/min, liquid nitrogen: -145°C/min). In vivo, measured inside the keloid, the argon gas device showed a lower end temperature than the liquid nitrogen device (argon gas: -36.4°C, liquid nitrogen: -8.1°C) and a faster freezing rate (argon gas: -14.7°C/min, liquid nitrogen: -5°C/min). The outer surface of the scar reached temperatures below -20°C with both devices as measured with the thermal camera. CONCLUSION: In conclusion, the argon gas device displayed a lower end temperature and a faster freezing rate in vivo compared to the liquid nitrogen device. Although this resulted in lower recurrence rates for the argon gas device, more hypopigmentation was seen compared to the liquid nitrogen device following treatment. Finally, the low outer surface temperatures measured with both devices, suggest that some hypopigmentation following treatment is inevitable.

Comparison of two scoring systems in the assessment of nasolabial appearance in cleft lip and palate patients.

OBJECTIVE: The aim of this study was to determine the reliability of 2 scoring systems. DESIGN: This study used a retrospective analysis of the results of complete unilateral cleft lip and palate patients. SETTING: The study was conducted at the VU Medical Center and the Academic Center for Dentistry of Amsterdam. PATIENTS: Patients were complete unilateral cleft lip and palate patients at the age of 6 years. MAIN OUTCOME MEASURES: Assessment of the nose and lip together and separately with a numerical photographic reference scoring system and with a 5-point ordinal scale without the use of a reference photograph by 6 judges. Intraobserver and interobserver reliability was calculated; both ways of assessment were compared by using Kendall tau. RESULTS: Photographs were available of 55 children (6 years old, 38 boys and 17 girls) with a complete unilateral cleft lip and palate. The interobserver reliabilities of the lip and nose together were 0.53 and, for the nose and lip separately, 0.51 and 0.43, respectively with the use of the numerical scale. In the 5-point scale, these were 0.55 for the nose and lip together and 0.57 and 0.45 for the nose and lip separately, respectively. Furthermore, it was found that the lip dominates in the scorings of the lip and nose together (linear regression analysis). CONCLUSIONS: The 2 tested systems are equivalent in their reliability and outcome. The lip is dominating in the overall scorings. It is advocated to use the 5-point scale without the use of a reference photograph and to assess the lip and nose separately.

MRI screening for silicone breast implant rupture: accuracy, inter- and intraobserver variability using explantation results as reference standard.

OBJECTIVES: The recall of Poly Implant Prothèse (PIP) silicone breast implants in 2010 resulted in large numbers of asymptomatic women with implants who underwent magnetic resonance imaging (MRI) screening. This study's aim was to assess the accuracy and interobserver variability of MRI screening in the detection of rupture and extracapsular silicone leakage. METHODS: A prospective study included 107 women with 214 PIP implants who underwent explantation preceded by MRI. In 2013, two radiologists blinded for previous MRI findings or outcome at surgery, independently re-evaluated all MRI examinations. A structured protocol described the MRI findings. The ex vivo findings served as reference standard. RESULTS: In 208 of the 214 explanted prostheses, radiologists agreed independently about the condition of the implants. In five of the six cases they disagreed (2.6 %), but subsequently reached consensus. A sensitivity of 93 %, specificity of 93 %, positive predictive value of 77 % and negative predictive value of 98 % was found. The interobserver agreement was excellent (kappa value of 0.92). CONCLUSIONS: MRI has a high accuracy in diagnosing rupture in silicone breast implants. Considering the high kappa value of interobserver agreement, MRI appears to be a consistent diagnostic test. A simple, uniform classification, may improve communication between radiologist and plastic surgeon. KEY POINTS: MRI has a high accuracy in diagnosing rupture in silicone breast implants. MRI appears to be a consistent diagnostic test with excellent interobserver agreement. A simple, uniform classification system, improves communication between radiologist and plastic surgeon. The interobserver agreement on implant rupture is higher than on extracapsular leakage.

Minimal extracorporeal circulation (MECC) does not result in less hypertrophic scar formation as compared to conventional extracorporeal circulation (CECC) with dexamethasone.

INTRODUCTION: Cardiopulmonary bypass surgery is associated with a systemic inflammatory response through the interaction of air, blood and synthetic components in the bypass system and the physical trauma of surgery. An alternative cardiopulmonary bypass system, minimal extracorporeal circulation (MECC), has shown promising results in terms of reducing the inflammatory response. We hypothesized that this system may reduce pathological excessive scarring. To study this assumption, the effects of MECC and the effects of conventional extracorporeal circulation (CECC) with dexamethasone on skin scarring were compared in a standardized wound-healing model. METHODS AND RESULTS: Pre-sternal scars were evaluated prospectively at four and 12 months postoperatively. The height and width of the scars were measured, using a slide caliper and sonography. The scars were scored using the validated Patient and Observer Scar Assessment Scale. Additional risk factors for hypertrophic scar formation were identified by means of a questionnaire. During surgery, MECC was used in 45 patients and CECC/dexamethasone in 42 patients. Four months postoperatively, 22 patients of the MECC group (49%) and 18 patients in the CECC/dexamethasone group (43%) had developed hypertrophic scars. Twelve months postoperatively, the hypertrophic scars in four patients of the MECC group and in two patients of the CECC/dexamethasone group had become normotrophic. In 18 patients of the MECC group (38%) and 16 patients of the CECC group (41%) the scars remained hypertrophic at 12 months. These differences between the two groups were not statistically significant. CONCLUSION: MECC does not reduce hypertrophic scar formation compared with CECC with dexamethasone, but its use is more beneficial than the use of CECC/dexamethasone because of the circulatory and immunological advantages and because treatment with dexamethasone can be omitted.

Randomized clinical trial of donor-site wound dressings after split-skin grafting.

BACKGROUND: The aim was to study which dressing material was best for healing donor-site wounds (DSWs) after split-skin grafting as there is wide variation in existing methods, ranging from classical gauze dressings to modern silicone dressings. METHODS: This 14-centre, six-armed randomized clinical trial (stratified by centre) compared six wound dressing materials in adult patients with DSWs larger than 10 cm(2) . Primary outcomes were time to complete re-epithelialization and pain scores measured on a visual analogue scale (VAS) over 4 weeks. Secondary outcomes included itching (VAS, over 4 weeks), adverse events and scarring after 12 weeks rated using the Patient and Observer Scar Assessment Scale (POSAS). RESULTS: Between October 2009 and December 2011, 289 patients were randomized (of whom 288 were analysed) to either alginate (45), film (49), gauze (50), hydrocolloid (49), hydrofibre (47) or silicone (48) dressings. Time to complete re-epithelialization using hydrocolloid dressings was 7 days shorter than when any other dressing was used (median 16 versus 23 days; P < 0·001). Overall pain scores were low, and slightly lower with use of film dressings (P = 0·038). The infection rate among patients treated with gauze was twice as high as in those who had other dressings (18 versus 7·6 per cent; relative risk 2·38, 95 per cent confidence interval 1·14 to 4·99). Patients who had a film dressing were least satisfied with overall scar quality. CONCLUSION: This trial showed that use of hydrocolloid dressings led to the speediest healing of DSWs. Gauze dressing should be discontinued as they caused more infections. REGISTRATION NUMBER: NTR1849 (http://www.trialregister.nl).

Scoring systems of cleft-related facial deformities: a review of literature.

Objective : There is a need for an internationally agreed objective method of assessing cleft-related deformities in order to compare the results of individual surgeons and different surgical techniques or to determine the optimal timing for primary lip closure. To assess the current methods, an overview of the recent developments in postoperative scoring systems of cleft-related deformities was made. Methods : A Medline search from June 2003 through July 2011 was conducted, and references in the selected articles were checked. This search yielded 428 articles, and after application of the inclusion and exclusion criteria, 40 articles were included in this review. Results : Twenty-five studies used two-dimensional (2D) photographs for the assessment of cleft-related deformities. Fourteen of these studies used a subjective method for the assessment and 11 performed anthropometric measurements. Good reliability has been found for subjective assessments and measurements from 2D photographs. Fifteen studies assessed three-dimensional (3D) imaging. Conclusions : Although there is a wide variety in study design, 3D imaging seems most reliable in assessing cleft-related facial deformities. However, scoring on 2D photographs is easier to perform and more applicable in daily practice because all cleft patients are photographed through the course of their treatment.