Effect of Keloid Properties on Treatment Efficacy, a Systematic Review.

BACKGROUND: The efficacy of keloid treatment in randomized studies is highly variable. However, no systematic review has been performed to evaluate the effect of different keloid properties on treatment efficacy. OBJECTIVE: To identify clinically relevant keloid properties that may influence treatment efficacy. MATERIALS AND METHODS: An electronic database search was conducted. Two reviewers independently selected randomized controlled trials (RCTs) and performed a methodologic quality assessment using the Cochrane risk-of-bias 2.0 tool. RESULTS: One thousand five hundred twenty studies were screened, and 16 RCTs, involving 1,113 patients, were included. The authors found lower efficacy in older keloids ( n = 3), keloids located on the chest, extremities, pinna, and shoulder ( n = 3), larger keloids ( n = 2), lower baseline Vancouver Scar Scale score ( n = 1), and keloids with history of recurrence ( n = 1). Overall, most studies had a high risk of bias. CONCLUSION: Only a minority of studies specifically addressed keloid properties, which makes comparisons between studies challenging. The authors' results suggest that keloid location, duration prior to treatment, size, history of recurrence, and severity are clinically relevant keloid properties that affect treatment efficacy. Further studies are crucial to corroborate the authors' findings, establish a clinically relevant keloid classification, and ultimately develop an evidence-based treatment algorithm that takes these properties into account.

The JAK-STAT pathway in keloid pathogenesis: a systematic review with qualitative synthesis.

Keloid tissues contain inflammatory cells and upregulated pro-inflammatory cytokines. The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway mediate cellular responses to these cytokines. We performed a systematic review on the role of the JAK-STAT pathway in keloid pathogenesis and the evidence for JAK-STAT inhibitors in keloid treatment. The search combined the terms (1) keloid and (2) JAK or TYK or STAT and included MeSH terms and synonyms. Two reviewers screened the articles and assessed the full texts on eligibility. Data were collected on the tested drugs and molecules, the type of cells and tissues used in the experiments, and study findings on the association between the JAK-STAT pathway and keloid cells and tissues. A total of twenty preclinical studies were included. Eleven preclinical studies proved that STAT3 expression and phosphorylation are enhanced in keloid tissue and keloid fibroblasts. Thirteen different JAK and/or STAT inhibitors were investigated. Tested drugs inhibited keloid progression as demonstrated by different processes, including reduced collagen production, cell proliferation and migration, increased cell cycle arrest and apoptosis, enhanced antioxidant responses, decreased (paracrine) signalling, and decreased profibrotic gene expression. No clinical studies have been published to date. Preclinical studies indicate a role for the JAK-STAT pathway in keloid pathogenesis and a potential role for JAK-STAT inhibitors in keloid treatment. The effect of these drugs should be further investigated on relevant biomarkers in a human keloid skin model, preferably including immune cells besides keloid fibroblasts and keratinocytes and in clinical studies.

Gluteal Fasciocutaneous Flap Reconstruction After Salvage Surgery for Pelvic Sepsis.

BACKGROUND: Chronic pelvic sepsis mostly originates from complicated pelvic surgery and failed interventions. This is a challenging condition that often requires extensive salvage surgery consisting of complete debridement with source control and filling of the dead space with well-vascularized tissue. OBJECTIVE: This study aimed to describe the outcomes of gluteal fasciocutaneous flaps for the treatment of secondary pelvic sepsis. DESIGN: Retrospective single-center cohort study. SETTINGS: Tertiary referral center. PATIENTS: Patients who underwent salvage surgery for secondary pelvic sepsis between 2012 and 2020 using a gluteal flap were included in this study. MAIN OUTCOME MEASURES: Percentage of complete wound healing. RESULTS: In total, 27 patients were included, of whom 22 underwent index rectal resection for cancer and 21 had undergone (chemo)radiotherapy. A median of 3 (interquartile range, 1-5) surgical and 1 (interquartile range, 1-4) radiological interventions preceded salvage surgery during a median period of 62 (interquartile range, 20-124) months. Salvage surgery included partial sacrectomy in 20 patients. The gluteal flap consisted of a V-Y flap in 16 patients, superior gluteal artery perforator flap in 8 patients, and a gluteal turnover flap in 3 patients. Median hospital stay was 9 (interquartile range, 6-18) days. During a median follow-up of 18 (interquartile range, 6-34) months, wound complications occurred in 41%, with a reintervention rate of 30%. The median time to wound healing was 69 (interquartile range, 33-154) days, with a complete healing rate of 89% at the end of follow-up. LIMITATIONS: Retrospective design and heterogeneous patient population. CONCLUSIONS: In patients undergoing major salvage surgery for chronic pelvic sepsis, the use of gluteal fasciocutaneous flaps is a promising solution because of the high success rate, limited risks, and relatively simple technique. See Video Abstract at http://links.lww.com/DCR/C160 . RECONSTRUCCIN CON COLGAJO FASCIOCUTNEO GLTEO DESPUS DE UNA CIRUGA DE RESCATE POR SEPSIS PLVICA: ANTECEDENTES:La sepsis pélvica crónica esta causada principalmente por cirugías pélvicas complicadas e intervenciones fallidas. Esta es una condición desafiante que a menudo requiere una cirugía de rescate extensa que consiste en un desbridamiento completo controlando el orígen infeccioso y rellenando el espacio muerto con tejido bien vascularizado, como por ejemplo un colgajo de tejido autólogo. La pared abdominal (colgajo de recto abdominal) o la pierna (colgajo de gracilis) se utilizan principalmente como sitios donantes para esta indicación, mientras que los colgajos glúteos pueden ser alternativas atractivas.OBJETIVO:Describir los resultados de los colgajos fasciocutáneos glúteos en el tratamiento de la sepsis pélvica secundaria.DISEÑO:Estudio de cohortes retrospectivo en un solo centro.AJUSTES:Centro de referencia terciario.PACIENTES:Todos aquellos que se sometieron a cirugía de rescate por sepsis pélvica secundaria entre 2012 y 2020 utilizando un colgajo fasciocutáneo glúteo.PRINCIPALES MEDIDAS DE RESULTADO:El porcentaje de cicatrización completa de la herida.RESULTADOS:En total, se incluyeron 27 pacientes, de los cuales 22 fueron sometidos a resección rectal por cáncer indicada y 21 pacientes que habían recibido (quimio)radioterapia. Una mediana de tres (RIC 1-5) intervenciones quirúrgicas y una (RIC 1-4) intervenciones radiológicas precedieron a la cirugía de rescate durante una mediana de 62 (RIC 20-124) meses.La cirugía de rescate incluyó una resección parcial del sacro en 20 pacientes. El colgajo fasciocutáneo glúteo consistió en la confección de un colgajo en V-Y en 16 pacientes, un colgajo incluyendo la perforante de la arteria glútea superior en 8 y un colgajo de rotación de músculo glúteo en 3 pacientes.La mediana de estancia hospitalaria fue de nueve (RIC 6-18) días. Durante una mediana de seguimiento de 18 (IQR 6-34) meses, se produjeron complicaciones de la herida en el 41%, con una tasa de reintervención del 30%.La mediana de tiempo hasta la cicatrización de la herida fue de 69 (IQR 33-154) días con una tasa de cicatrización completa del 89 % al final del seguimiento cicatricial.LIMITACIONES:Diseño retrospectivo y población heterogénea de pacientes.CONCLUSIONES:En pacientes sometidos a cirugía mayor de rescate por sepsis pélvica crónica, el uso de colgajos fasciocutáneos glúteos es una solución prometedora debido a la alta tasa de éxito, los riesgos limitados y la técnica relativamente simple. Video Resumen en http://links.lww.com/DCR/C160 . (Traducción-Dr. Xavier Delgadillo ).

Intralesional Corticosteroid Administration in the Treatment of Keloids: A Scoping Review on Injection Methods.

BACKGROUND: Intralesional corticosteroid administration (ICA) is a first-line treatment for keloids. However, its clinical results are still highly variable and often suboptimal. Treatment results may strongly be influenced by various operator-dependent factors. The aim of this study was to map the details of ICA in keloids described in randomized controlled trials (RCTs), hence presenting the scientific practice of a first-line treatment for keloids in the best available evidence. SUMMARY: A systematic search was performed on PubMed, Ovid MEDLINE, Ovid EMBASE, and CENTRAL. Eligible studies were RCTs including patients with keloids treated with intralesional corticosteroids. Treatment and study design-related data were charted on a predefined form. Thirty-eight RCTs were included for data extraction. Triamcinolone acetonide was used in 37 (97.4%) studies. Dosing per cm2 could only be compared among ten (26%) studies and varied from 1 to 20 mg. The maximum dose per session varied from 20 to 80 mg. Local anesthetics were administered in seven (20%) RCTs. Treatment intervals varied from weekly to monthly, with 4 weeks most frequently (50%) used. Needle size was reported in eleven (29%) studies and varied from 26 to 30-gauge. Syringe size was specified in four (11%) studies, being 1 mL. The injection level was described in eleven (29%) studies. Blanching as endpoint was reported in ten (26%) studies. Outcome measures varied widely, from height, surface area, or volume, to Vancouver Scar Scale, Patient and Observer Scar Assessment Scale, pain and itch scores, patient satisfaction, and different efficacy rates. Only six studies had a follow-up of ≥6 months. Recurrence was identified in two studies with 18 weeks and 1 year of follow-up. Adverse events were reported in 23 (61%) studies.

Current Practice in Keloid Treatment: a Survey of Dutch Dermatologists and Plastic Surgeons.

BACKGROUND: Several therapeutic options are available for the treatment of keloids, but it remains unclear which treatment options are most commonly used by practitioners. OBJECTIVE: To explore the prevailing treatment for different keloid phenotypes among dermatologists and plastic surgeons in the Netherlands. METHODS: Members of the Dutch society for Plastic surgery and the Dutch society for Dermatology and Venereology were asked to participate. Questions elaborated on the treatment for a small and a large keloid on the mandibula and multiple keloids on the chest. RESULTS: One hundred forty-three responses were obtained. Heterogeneity in treatment was extremely high for the small, large, and multiple keloids with 27, 35, and 33 various first choices, respectively. Intralesional corticosteroids were most often chosen for all 3 different keloid phenotypes. These were mostly (61%) administered as monotherapy for the small keloid and mostly combined with other treatments for the large keloid (19%) and multiple keloids (43%). Surgery was chosen regularly (22%) for the large keloid, mostly combined with intralesional corticosteroids (10%) or brachytherapy (8.4%). CONCLUSION: Keloid treatment is very heterogeneous among dermatologists and plastic surgeons, even in a relatively small country as the Netherlands. Moreover, the treatment choice depends on the keloid phenotype.

Evaluating International Diagnostic, Screening, and Monitoring Practices for Craniofacial Microsomia and Microtia: A Survey Study.

To (1) appraise current international classification and clinical management strategies for craniofacial microsomia (CFM) and microtia, and (2) to assess agreement with the European Reference Network "European Guideline Craniofacial Microsomia" recommendations on screening and monitoring.This was a cross-sectional online survey study. The survey consisted of 44 questions on demographics, diagnostics and classification, obstructive sleep apnea, feeding difficulties, speech and language development, hearing, ocular abnormalities, visual development, orthodontic screening, genetic counselling, psychological wellbeing, and extracraniofacial anomalies.Respondents were participants of 3 international cleft and craniofacial conferences, members of the American Cleft Palate and Craniofacial Association and members of the International Society for Auricular Reconstruction. Respondents were requested to complete 1 questionnaire per multidisciplinary team.Fifty-seven responses were received from 30 countries (response rate ∼3%).The International Consortium for Health Outcomes Measurement diagnostic criteria were used by 86% of respondents, though 65% considered isolated microtia a mild form of CFM. The Orbit, Mandible, Ear, Facial Nerve and Soft Tissue classification system was used by 74% of respondents. Agreement with standardized screening and monitoring recommendations was between 61% and 97%. A majority of respondents agreed with screening for extracraniofacial anomalies (63%-68%) and with genetic counselling (81%).This survey did not reveal consistent agreement on the diagnostic criteria for CFM. Respondents mostly supported management recommendations, but frequently disagreed with the standardization of care. Future studies could focus on working towards international consensus on diagnostic criteria, and exploring internationally feasible management strategies.

Use of Patient-Reported Outcome Measures in the Surgical Treatment of Hidradenitis Suppurativa: A Systematic Review.

BACKGROUND: Surgery is considered to be the best treatment for recurrent hidradenitis suppurativa (HS). Although it is necessary to assess the effect on health-related quality of life (HR-QoL), patient-reported outcome measures (PROMs) are scarce and heterogeneously used in the literature about the surgical treatment of HS. OBJECTIVE: The aim of this study was to provide a review of the complete literature for different PROMs used in the surgical treatment of HS and to assess their methodological qualities. METHODS: A systematic literature search of PubMed, Medline, Cochrane, CINAHL, and Embase with an assessment following the COnsensus-based standards for the Selection of health status Measurement INstrument criteria. RESULTS: The search identified 218 articles, with the inclusion of 6 studies for analysis. Identified PROMs were as follows: the Dermatology Life Quality Index (DLQI), the Derriford Appearance Scale-24 (DAS-24), and the Work Productivity and Activity Impairment (WPAI). These non-disease-specific PROMs seem to have poor results concerning development and content validation. CONCLUSION: The DLQI, WPAI, and DAS-24 are generic PROMs with poor methodological qualities for PROM development and content validation. Hidradenitis suppurativa-specific instruments are not used in available studies because they have been developed recently and, therefore, partially validated. More research is needed to further investigate methodological qualities of HS-specific instruments.

A systematic review evaluating the influence of incisional Negative Pressure Wound Therapy on scarring.

Pathological scars can result in functional impairment, disfigurement, a psychological burden, itch, and even chronic pain. We conducted a systematic review to investigate the influence of incisional Negative Pressure Wound Therapy (iNPWT) on scarring. PubMed, EMBASE and CINAHL were searched for preclinical and clinical comparative studies that investigated the influence of iNPWT on scarring-related outcomes. Individual studies were assessed using the OHAT Risk of Bias Rating Tool for Human and Animal studies. The body of evidence was rated using OHAT methodology. Six preclinical studies and nine clinical studies (377 patients) were identified. Preclinical studies suggested that iNPWT reduced lateral tension on incisions, increased wound strength, and reduced scar width upon histological assessment. Two clinical studies reported improved patient-reported scar satisfaction as measured with the PSAS (1 year after surgery), POSAS, and a VAS (both 42, 90, and 180 days after surgery). Five clinical studies reported improved observer-reported scar satisfaction as measured with the VSS, SBSES, OSAS, MSS, VAS, and POSAS (7, 15, 30, 42, 90, 180, and 365 days after surgery). Three clinical studies did not detect significant differences at any point in time (POSAS, VAS, and NRS). Because of imprecision concerns, a moderate level of evidence was identified using OHAT methodology. Preclinical as well as clinical evidence indicates a beneficial influence of iNPWT on scarring. Moderate level evidence indicates that iNPWT decreases scar width and improves patient and observer-reported scar satisfaction.

Recurrence Rates Following Reconstruction Strategies After Wide Excision of Hidradenitis Suppurativa: A Systematic Review and Meta-analysis.

BACKGROUND: Wide excision (WE) is generally considered to be the most common treatment for recurrent hidradenitis suppurativa. When performed, excision is followed by decisions regarding best options for management of the surgical defect. Different reconstructive strategies (RSs) have been used, with varying rates of recurrence. OBJECTIVE: To provide an up-to-date systematic review of the complete literature for different RS after WE and their recurrence rates. METHODS: A systematic literature search of the complete available literature and a meta-analysis of proportions were performed on the included studies. RESULTS: Of a total of 1,813 retrieved articles, 79 were included in the analysis. Most were retrospective analyses, with only one randomized controlled trial (RCT) and 7 prospective analyses. The RS described were divided into primary closure (PC), secondary intention healing (SIH), skin graft (SG), and fasciocutaneous flaps (FCF). The average estimated recurrence for PC was 22.0% (95% confidence interval [CI], 8.0%-40.0%), for SIH 11.0% (95% CI, 5.0%-20.0%), for SG 2.0% (95% CI, 0.0%-5.0%), and for FCF 2.0% (95% CI, 1.0%-5.0%) (p < .001). Hidradenitis suppurativa below the umbilicus was significantly associated with overall recurrence (p = .006). Quality of evidence was poor, and the reporting of results was mostly heterogeneous. CONCLUSION: After WE, PC has the highest recurrence rates, whereas SG and FCF have the lowest rates. There is a need for more RCTs and guidelines, to be able to report uniformly on treatment outcomes.

A Systematic review and meta-analysis of sensate versus non-sensate flaps for the prevention of pressure ulcer recurrence among individuals with spinal cord disease.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: To identify, critically appraise, and synthesize research findings on non-sensate versus sensate flaps among individuals with spinal cord disease and pelvic pressure ulcers, with pressure ulcer recurrence as primary outcome. METHODS: PubMed, EMBASE, and Cochrane CENTRAL were screened for relevant studies. Data on surgical characteristics, ulcer recurrence, and sensory outcomes were retrieved and tabulated. Risk of bias was assessed with MINORS. The level of evidence was evaluated with GRADE. Meta-analysis was performed when possible. RESULTS: Meta-analysis of 1794 non-sensate locoregional reconstructions indicated a recurrence rate of 34% within several years (95% CI, 27-42). Twenty-one articles provided data on 75 sensate reconstructions, performed in 74 individuals. Meta-analysis of the sensate reconstructions indicated a recurrence rate of 1% (95% CI, 0-8). Sensate reconstructions were not associated with an increase of wound complications (19%; 95% CI, 7-40) compared with non-sensate ones (34%; 95% CI, 27-42). A very low level of evidence was determined with use of GRADE. CONCLUSION: Although of a very low-level, the present evidence suggests that restoration of sensory innervation may be an effective intervention for the prevention of pressure ulcer recurrence among individuals with spinal cord disease. A prospective RCT is needed to confirm or refute the results of this systematic review.

A Multicenter Analysis of Wide Excision and Reconstruction for Severe Anogenital Hidradenitis Suppurativa.

BACKGROUND: An appropriate reconstruction strategy after wide excision for severe cases of anogenital hidradenitis suppurativa (aHS) is important to optimize outcomes, but there is no consensus on which reconstruction strategy should be preferred. OBJECTIVE: Evaluate which reconstruction strategy after wide excision in patients with severe aHS is associated with the best outcomes in terms of recurrence rate, complications and patient-reported outcomes on range of motion, pain, appearance, sexual health and satisfaction. METHODS: Multicenter retrospective analysis between 2009 and 2019 of wide excision and reconstruction by primary closure, secondary intention healing, split-thickness skin grafts or fasciocutaneous flaps (FCF). The recurrence rate was the primary endpoint of multivariable logistic regressions to determine variables with an independent effect on recurrence. RESULTS: A total of 93 patients were included. The overall recurrence rate was 62% after a median follow-up of 43 months, without statistical significance between reconstruction strategies (P = 0.737). The number of interventions during follow-up was an independent risk factor for recurrence (odds ratio, 2.55; confidence interval, 1.24-5.25; P = 0.011). Complications (37%) were more severe after FCF (P = 0.007). The mean score regarding patient-reported outcomes was 14.9 ± 2.8, of 24, with best appearance after FCF (P = 0.042). CONCLUSIONS: These long-term follow-up data on severe aHS demonstrate a high recurrence rate after wide excision and reconstruction. Patients should be informed that treatment consists of long-term medicinal and surgical interventions with high recurrence rates, and surgeons may choose their own preferred reconstruction methods. Furthermore, more attention should be paid to the sexual health of patients with aHS.

Dorsal approach with tailored partial sacrectomy and gluteal V-Y fasciocutaneous advancement flap for the management of recurrent pelvic sepsis; case report.

BACKGROUND: Pelvic sepsis after surgery for rectal cancer is a severe complication, mostly originating from anastomotic leakage. Complex salvage surgery, during which an omentoplasty is often used for filling of the pelvic cavity, is seldomly required. If this fails, a symptomatic recurrent presacral abscess with a risk of progressive inflammation can develop. Such patients have often undergone multiple surgeries and have disturbed abdominal wall integrity, adhesion formation, and presence of one or two stoma(s). Subsequent salvage surgery via the conventional anterior abdominal approach is therefore less suitable. We describe three cases with a chronic presacral sinus and failure of first salvage surgery. All three patients underwent a prone only approach with tailored sacrectomy. This novel approach provided direct access to the pelvic abscess with optimal exposure for complete and safe debridement. A unilateral or bilateral gluteal V-Y fasciocutaneous advancement flap was created to completely fill the cavity with well vascularized tissue. CASE PRESENTATIONS: Three male patients of 80, 66 and 51 years of age initially underwent low anterior resection with neo-adjuvant radiotherapy for rectal cancer. The first patients underwent intersphincteric resection of the anastomosis with omentoplasty 128 months after index surgery, and second salvage surgery 2 months later. The second patient underwent abdominoperineal resection with omentoplasty for locally recurrent rectal cancer, cystoprostatectomy with revision of the omentoplasty for pelvic sepsis 100 months after index surgery, and second salvage surgery 16 months later. In the third patient, the anastomosis was dismantled with subsequent intersphincteric proctectomy and omentoplasty 20 months after index surgery, and second salvage surgery was performed 93 months later. Second salvage surgery in all three patients was indicated because of symptomatic recurrent pelvic sepsis. Second salvage surgery consisted of sacrectomy, complete debridement of the presacral area, and filling with a gluteal advancement flap. This resulted in favorable postoperative recovery with ultimate healing of the pelvic cavity. CONCLUSION: The dorsal approach with tailored sacrectomy and gluteal V-Y advancement flap is a valuable option in highly selected patients to treat recurrent pelvic sepsis after multiple prior transabdominal interventions for chronic presacral sinus.

Meta-analysis, Meta-regression, and GRADE Assessment of Randomized and Nonrandomized Studies of Incisional Negative Pressure Wound Therapy Versus Control Dressings for the Prevention of Postoperative Wound Complications.

OBJECTIVE: The aim of this study was to evaluate the efficacy of iNPWT for the prevention of postoperative wound complications such as SSI. SUMMARY OF BACKGROUND DATA: The 2016 WHO recommendation on the use of iNPWT for the prevention of SSI is based on low-level evidence, and many trials have been published since. Preclinical evidence suggests that iNPWT may also prevent wound dehiscence, skin necrosis, seroma, and hematoma. METHODS: PubMed, EMBASE, CINAHL, and CENTRAL were searched for randomized and nonrandomized studies that compared iNPWT with control dressings. The evidence was assessed using the Cochrane Risk of Bias Tool, the Newcastle-Ottawa scale, and GRADE. Meta-analyses were performed using random-effects models. RESULTS: High level evidence indicated that iNPWT reduced SSI [28 RCTs, n = 4398, relative risk (RR) 0.61, 95% confidence interval [CI]: 0.49-0.76, P < 0.0001, I = 27%] with a number needed to treat of 19. Low level evidence indicated that iNPWT reduced wound dehiscence (16 RCTs, n = 3058, RR 0.78, 95% CI: 0.64-0.94). Very low-level evidence indicated that iNPWT also reduced skin necrosis (RR 0.49, 95% CI: 0.33-0.74), seroma (RR 0.43, 95% CI: 0.32-0.59), and length of stay (pooled mean difference -2.01, 95% CI: -2.99 to 1.14). CONCLUSIONS: High-level evidence indicates that incisional iNPWT reduces the risk of SSI with limited heterogeneity. Low to very low-level evidence indicates that iNPWT also reduces the risk of wound dehiscence, skin necrosis, and seroma.

Recurrence Rates Following Excision of Hidradenitis Suppurativa: A Systematic Review and Meta-analysis.

BACKGROUND: Surgery is considered to be the best treatment for recurrent hidradenitis suppurativa (HS). Varying recurrence rates have been reported in the literature. OBJECTIVE: To provide an up-to-date systematic review of the complete literature for different excision strategies and their recurrence rates in HS. METHODS: A systematic literature search of the complete available literature and a meta-analysis of proportions were performed on the included studies. RESULTS: Of a total of 1,593 retrieved articles, 125 were included in the analysis. Most of these studies were retrospective with 8 prospective analyses and one randomized controlled trial (RCT). The techniques described were divided into partial excision (PE) and wide excision (WE), described in 33 and 97 included studies, respectively. The average estimated recurrences were 26.0% (95% confidence interval [CI], 16.0%-37.0%) for PE and 5.0% (95% CI, 3.0%-9.0%) for WE (p < .01). Female sex (p = .016) and HS caudal of the umbilicus (p = .001) were significantly associated with the overall recurrence rate. Quality of evidence was poor, and the reporting of results was mostly heterogeneous. CONCLUSION: This systematic review showed higher recurrence rates when it was not intended to resect affected HS tissue with a radical margin. There is a need for more RCT's and uniformly reported treatment outcomes.

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study).

BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.

Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage breast reconstruction (BRIOS): primary outcome of a randomised, controlled trial.

BACKGROUND: There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR. METHODS: This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446. FINDINGS: Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19). INTERPRETATION: Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.

Mobile ultra-clean unidirectional airflow screen reduces air contamination in a simulated setting for intra-vitreal injection.

The aim of this study is to determine whether the use of a mobile ultra-clean laminar airflow screen reduces the air-borne particle counts in the setting of a simulated procedure of an intra-vitreal injection. A mobile ultra-clean unidirectional airflow (UDF) screen was tested in a simulated procedure for intra-vitreal injections in a treatment room without mechanical ventilation. One UDF was passed over the instrument tray and the surgical area. The concentration of particles was measured in the background, over the instrument table, and next to the ocular area. The degree of protection was calculated at the instrument table and at the surgical site. Use of the UDF mobile screen reduced the mean particle concentration (particles > 0.3 microns) on the instrument table by a factor of at least 100.000 (p < 0.05), and over the patient's eye by at least a factor of 436 (p < 0.05), which in clinical practice translates into significantly reduced air contamination. Mobile UDF screen reduces the mean particle concentration substantially. The mobile UDF screen may therefore allow for a safer procedural environment for ambulatory care procedures such as intra-vitreal injections in treatment rooms.

Shared Decision-Making in Cosmetic Medicine and Aesthetic Surgery.

Shared decision-making (SDM) invokes the bidirectional communication between physicians and patients required to involve the patient's preference in the eventual treatment choice. This paper will explain what SDM is, why it is important, and how it is performed in clinical practice. It is an essential part of evidence-based medicine, as it helps determine whether the available evidence on the possible benefits and harms of treatment options match the patient's characteristics and preferences. Cosmetic medicine and aesthetic surgery seem to be obvious fields of medicine in which SDM should be applied to achieve high-quality care.

Professional opinion on oral cleft during pregnancy: a comparison between Israel and The Netherlands.

OBJECTIVE: The aim of this study was to assess the opinion of obstetric care providers who perform prenatal ultrasounds to screen for anomalies and who advise women about their options, including termination of pregnancy, when an oral cleft is detected. We compared providers' opinions about pregnancy termination for isolated oral cleft in The Netherlands, where the number of terminations is low, and in Israel, where the number is high. METHODS: Online questionnaires were used. The questions assessed the providers' views regarding the estimated burden of treatment, the functioning ability, and the level of happiness of children with an oral cleft and their parents. Additionally, we assessed providers' opinions on pregnancy termination for isolated oral cleft. RESULTS: In The Netherlands, more professionals considered oral cleft a disability (rate differences 17.8%, 95% confidence interval: 0.5-33.1%) than in Israel. In the Netherlands, 10.6% of respondents (compared with 11.1% in Israel) thought that an isolated cleft was a reason for terminations of pregnancy (TOP) (rate differences 0.6%, 95% confidence interval: -12% to 10.9%). CONCLUSIONS: Prenatal care providers in The Netherlands and Israel do not differ in their opinions about the severity of oral cleft and the acceptability of TOP for an isolated oral cleft. This study shows that prenatal care providers' attitudes do therefore not explain the dramatic difference between these countries in the number of TOP for isolated oral cleft.