The process to obtain reimbursement for enzymatic debridement in clinically deep burns.

INTRODUCTION: Burn eschar removal by enzymatic debridement with NexoBrid® (EDNX) results in a maximum preservation of all viable tissue, which is the main advantage over traditional tangential excision. The authors participated in a marketing authorization holder process to obtain reimbursement from the national health authorities in Belgium. MATERIAL AND METHODS: The reimbursement process consisted of three phases, as specified by the reimbursement regulations required by the Belgian National Institute for Health and Disability Insurance (NIHDI). RESULTS: Forty-one patients with clinically deep 2nd and 3rd degree burns, treated with EDNX in two Belgian burn centers, were included in the registry for the first phase of the reimbursement process. The total success rate of the EDNX treatment was 95.1% (39/41). Over half of the burn wounds treated with NexoBrid® (55.2%) did not require any additional surgical debridement or skin grafting. To obtain definitive reimbursement, an extra 16 patients were included. In this population, 51.4% did not require any surgical intervention. The total success rate of the EDNX debridement in this group was 100%. Based on an estimated market share of 12% and around 75 patients in the third year after final reimbursement, a market access consultant calculated that NexoBrid® will realize yearly savings for the Belgian Healthcare budget of at least €30.000. CONCLUSION: Based on the results of this Belgian registry study in combination with the yearly healthcare budget savings, the NIHDI granted a final reimbursement for EDNX treatment in adults, endorsed by the Minister of Health on November 5th, 2019.

Helpful hints in deciding what and when to operate after enzymatic debridement.

INTRODUCTION: In recent years, it has become clear that the burn eschar in deep burns can be selectively removed using the enzymatically debriding agent NexoBrid® (EDNX). In deep partial-thickness burns, such selective debridement preserves all non-injured dermis, which is sometimes sufficient for spontaneous re-epithelization. Nevertheless, it can be extremely challenging to determine exactly what and when to operate after an EDNX procedure. In this manuscript, we sought to investigate the clinical aspect of the enzymatically debrided wound bed of laser Doppler imaging (LDI)-confirmed deep dermal and full-thickness burns after NexoBrid® application. This to evaluate the residual wound healing capacity and implement specific indications for surgical therapy after enzymatic debridement. MATERIAL AND METHODS: Mainly LDI-blue areas, determined between 48 h and 5d after burn and afterwards treated with EDNX were selected. Six practical and three expert EDNX users evaluated the high-quality digital images of the wound beds immediately post NexoBrid® removal and after a 2 h wet-to-dry (WTD) dressing period. RESULTS: One hundred and two mainly LDI-blue areas in 32 patients were analyzed. Regarding the early decision-making, there were no significant differences in the wound bed evaluations, wound healing assessment and treatment decision of all 9 EDNX users post EDNX removal versus post WTD. Moreover, there was a good to excellent consensus between the practical and expert EDNX users in the individual wound bed evaluations. Even in the evaluation of a newly developed wound bed color code, with 7 different colors/patterns to choose from, the consensus was 80%. There was also an 84% consensus on the decision whether or not to operate. All mainly LDI-blue areas with incomplete enzymatic debridement, determined during clinical investigation by expert EDNX users, required surgery. Additionally, the expert investigators demonstrated that the following wound bed characteristics were independent predictors of the need for surgical treatment: visible fat lobules (p = 0.028), translucent fat lobules (p < 0.001), dermal step-off in the wound bed (p < 0.001), visible blood vessels (p < 0.001) and coagulated blood vessels (p = 0.023). Also, higher color code ranges on our own developed wound bed classification were significantly related to a surgical intervention (p = 0.006). When including the LDI flux values, the perfusion units were significantly different (p < 0.001) between the exclusively LDI-blue areas treated conservatively (mean 145.7) and the areas ultimately treated with autografts (mean 119.5). CONCLUSION: To the best of our knowledge, this study is the first to address the clinical wound bed evaluation of LDI-confirmed deep burns after NexoBrid® application. Based on our results, it is recommended to evaluate the wound bed twice: immediately after removing NexoBrid® to assess the viability of the wound bed and after the WTD period to reach a more complete decision. During these evaluations, wound bed characteristics such as incomplete debridement, visible and/or translucent fat lobules, visible and/or coagulated blood vessels and a dermal step-off in the wound bed combined with a higher range (4-5) in the newly developed wound bed color code should lead to an early and reliable decision for skin grafting. For burn centers using LDI, mean flux values below 119.5PU - in addition to the above-mentioned wound bed evaluation - are a clear indicator for surgical therapy.

Donor Site Morbidity after Lumbar Artery Perforator Flap Breast Reconstruction.

BACKGROUND: The lumbar artery perforator flap is a second-choice flap in autologous breast reconstruction whenever a deep inferior epigastric artery perforator (DIEP) flap is not possible. Ideal candidates are pear-shaped women who do not have enough bulk on the abdomen or thighs. Patient-reported "satisfaction with breasts" is excellent but we were curious about the donor site morbidity. METHODS: We performed a retrospective study of all lumbar flap breast reconstructions performed between 2010 and 2019. Patients were invited by e-mail and telephone to take part in a BREAST-Q survey. RESULTS: One hundred fifty-four flaps were performed in 110 patients. Sixty-three patients filled out the BREAST-Q questionnaire. The most frequently observed donor site complications are seroma (35.1%), dehiscence (8.4%), and hematoma (3.2%). Correction of the donor site scar was performed in 31.8% of patients, lipofilling of the donor flank in 5.2%, and liposuction of the contralateral flank in 18.3% of patients. Body mass index (BMI) was the only significant risk factor for donor site complications. Patient-reported "satisfaction with donor site appearance" was good but significantly lower for primary reconstructions compared with secondary and tertiary procedures. Flap weight significantly influences patient-reported "physical wellbeing of the donor site." Ninety-seven percent of patients would recommend the surgery to someone in a similar position and would do it all over. CONCLUSION: The lumbar artery perforator flap is a good alternative for breast reconstruction in selected patients. The donor site issues consist mainly of seromas, prolonged discomfort, and a scar that might be noticeable to others, but patient-reported satisfaction is very high.

Fifteen-Year Experience with the Ghent Technique of Penile Inversion Vaginoplasty.

BACKGROUND: Demand for male-to-female gender-affirmation surgery is rising. Creation of a vaginal vault and a feminine vulva remains challenging, especially in circumcised patients. The authors present the 15-year results of the technique developed by the senior author (S.M.). METHODS: A retrospective case review was performed of all penile inversion vaginoplasties carried out by the senior author between 2003 and 2017. Age, hormonal therapy time, body mass index, smoking, diabetes, circumcision, and the need for full-thickness skin grafts to lengthen the vaginal vault were investigated as potential risk factors for postoperative complications. RESULTS: A total of 384 penile inversion vaginoplasties were retained, with 85.7 percent of patients requiring a full-thickness skin graft to lengthen the vaginal vault. Rectum perforation occurred in six patients (1.6 percent). Early revisions were necessary in 8.4 percent of patients and late revision surgery was performed in 37.1 percent of cases. There was no independent risk factor for early complications. Diabetes was an independent risk factor for late revision surgery. After vaginoplasty, 97.2 percent of patients reported being able to engage in penetrative intercourse, and 83.4 percent of patients reported having orgasms. CONCLUSIONS: Vaginoplasty is possible in all trans women, with most patients being able to engage in penetrative intercourse and reach an orgasm. To reach the desired depth of 14 cm, the neovaginal vault is usually lined with full-thickness skin grafts from the scrotum and/or abdomen. Diabetes was the only independent risk factor for revision surgery. Rectal tears are a rare complication and can usually be managed conservatively. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

A Novel Technique for Preventive Lymphovenous Anastomosis: Anastomosing a Ligated Lymphatic Vessel.

BACKGROUND: Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities. These procedures require experienced supramicrosurgeons and can be time consuming, which might be the reasons why prophylactic LVA has not yet been widely implemented in the treatment of cancer. Due to the small diameter of lymphatic vessels, it remains challenging to identify the lumen, and therefore, anastomoses are prone to back wall stitching. Different inventive procedures have been described making use of stents or monofilament sutures. METHODS: In this article, we describe a newly developed and straightforward technique for LVA in 4 patients who underwent an axilla dissection and 1 patient who underwent a dissection of the groin lymph nodes. This latter approach makes use of clipping of the lymphatic vessel during lymph node dissection, and remains ligated during anastomosis. The candidate vein was the V. thoracodorsalis for the axilla and the V. circumflexa superficialis for the groin. We describe the feasibility, average duration, and complications. RESULTS: Performing an end-to-side anastomosis on a clipped lymphatic vessel minimizes the problem of back wall stitching as well as the trouble of finding the lumen due to collapsing of the vessel. The turgor of the lymphatic vessel is maintained and makes anastomosing easy. Average time for LVA was 33.4 minutes and 1 minor complication was seen. CONCLUSION: We believe that this approach might be of value in popularizing LVA in the treatment or prevention of different conditions such as breast cancer-related lymphedema.

Nipple reconstruction in autologous breast reconstruction after areola-sparing mastectomy.

INTRODUCTION: The number of patients requesting prophylactic mastectomy with immediate reconstruction is rising. The oncological safety of techniques preserving the nipple and/or areola complex is still controversial. Nevertheless, nipple-sparing mastectomy (NSM) and areola-sparing mastectomy (ASM) are becoming increasingly popular. After ASM, traditional nipple reconstruction techniques can be a disappointment and can lead to a deep groove around the new nipple. We describe a technique to overcome these issues and analyzed how three types of mastectomy (skin-sparing mastectomy or SSM, ASM, and NSM) compare to one another by looking into the number of wound infections, extra procedures for the loss of projection, nipple necrosis, and BREAST-Q scores. METHODS: We retrospectively analyzed 467 breast reconstructions performed in 351 patients between 2011 and 2017 at the University Hospital of Gent. Patients were asked to fill out the BREAST-Q questionnaire and patient-reported outcomes were analyzed and correlated to demographic information. RESULTS: Patients undergoing a nipple reconstruction after ASM are experiencing similar rates of wound problems, extra surgical procedures for the loss of projection and necrosis, compared to women with a history of SSM. When considering the "satisfaction with breast" and "satisfaction with outcome" modules of the BREAST-Q, we noted that nipple-sparing mastectomy (NSM) patients report lower scores than SSM and ASM patients and ASM patients seem to report a higher "satisfaction with nipple," than the other two treatment groups. CONCLUSION: An ASM is a valuable alternative to a nipple-sparing mastectomy and leads to a good esthetic result and patient satisfaction.

Evidence Based Burn Depth Assessment Using Laser-Based Technologies: Where Do We Stand?

Early clinical assessment of burn depth and associated healing potential (HP) remains extremely challenging, even for experienced surgeons. Inaccurate diagnosis often leads to prolonged healing times and unnecessary surgical procedures, resulting in incremental costs, and unfavorable outcomes. Laser Doppler imaging (LDI) is currently the most objective and accurate diagnostic tool to measure blood flow and its associated HP, the main predictor for a patient's long-term functional and aesthetic outcome. A systematic review was performed on non-invasive, laser-based methods for burn depth assessment using skin microcirculation measurements to determine time to healing: Laser Doppler flowmetry (LDF), LDI and laser speckle contrast imaging (LSCI). Important drawbacks of single point LDF measurements are direct contact with numerous small points on the wound bed and the need to carry out serial measurements over several days. LDI is a fast, "non-contact," single measurement tool allowing to scan large burned areas with a 96% accuracy. LDI reduces the number of surgeries, improves the functional and aesthetic outcome and is cost-effective. There is only limited evidence for the use of LSCI in burn depth assessment. LSCI still needs technical improvements and scientific validation, before it can be approved for reliable burn assessment. LDI has proven to be invaluable in determining the optimal treatment of a burn patient. For unclear reasons, LDI is still not routinely used in burn centers worldwide. Additional research is required to identify potential "barriers" for universal implementation of this evidence-based burn depth assessment tool.

Comparing the Lumbar and SGAP Flaps to the DIEP Flap Using the BREAST-Q.

BACKGROUND: The deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. When the abdomen is not available, alternative donor sites can be found at the buttock, the lumbar region, or the thighs. These flaps are referred to as second-choice flaps. This study compares the superior gluteal artery perforator (SGAP) flap and the lumbar artery perforator (LAP) flap to the DIEP flap using patient-reported outcomes. METHODS: A retrospective study was performed reviewing the records of 417 women who underwent a free flap breast reconstruction with either a DIEP, an LAP, or an SGAP flap, between 2006 and 2018. Patients were asked to fill out the BREAST-Q questionnaire, and patient-reported outcomes were analyzed and correlated to the demographic information. RESULTS: The response rate was 54.5 percent, with 50 LAP, 153 DIEP, and 25 SGAP flap patients participating. When questioned about their satisfaction with breasts and satisfaction with outcome, all three procedures were rated similarly high. When comparing the physical well-being of the donor site and appearance of the donor site, LAP flap patients reported significantly lower scores than DIEP and SGAP flap patients. CONCLUSIONS: Patients who undergo LAP or SGAP flap breast reconstruction seem similarly satisfied with the appearance and outcome of their free flap breast reconstruction compared with DIEP flap patients. The donor-site morbidity and its impact on the patient's well-being in SGAP and LAP flap patients have been underestimated. Despite more donor-site discomfort, the LAP and SGAP flaps are feasible alternatives whenever the DIEP flap is not possible.

Injuries associated with electronic nicotine delivery systems: A systematic review.

BACKGROUND: Since its introduction on the market in 2007, the number of reports on injuries caused by the overheating, ignition, or explosion of electronic nicotine delivery systems (ENDSs) has increased significantly. These injuries appear to have different causes, the most important one being lithium-ion battery overheating to the point of ignition or explosion. METHODS: A literature search for all relevant studies concerning ENDS-related traumatic injuries of all kinds was conducted, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses protocol. The search started with the first introduction of ENDSs in 2007 and ended February 2020. Articles included were reports on patients who sustained flame, chemical, or traumatic injuries of the skin, soft tissue, and/or bone, related to the use of ENDSs. RESULTS: This systematic review includes 180 patients from 41 case series and reports, published between 2016 and 2020. The mean age was 30.8 years (range, 17-59 years) with an overall male predominance (168 of 180 patients, 93%). In most injuries, multiple anatomical sites were affected, with the thigh/lower limb being the most commonly injured area (77%) followed by the upper limb/hand (43%). Eighty-two patients (51%) required a surgical treatment, 70 patients (43%) were managed conservatively with dressings or ointments, and 9 patients (6%) underwent enzymatic debridement. Thirty-five percent of all patients underwent skin grafting. CONCLUSION: Injuries from overheating, ignition, or explosion of ENDSs are an emerging, underreported, and underresearched issue. There is a need for increased regulation of ENDSs and improved surveillance of related injuries. Both health care providers and consumers should be made aware of the risks and be advised about how to safely handle these devices. In contrast to other articles, this systematic review includes all types of injuries related to ENDS overheating, ignition, and explosion. To our knowledge, this is the most extensive systematic review performed to date. LEVEL OF EVIDENCE: Review article, level III.

Enzymatic debridement as an effective treatment for combined flame and chemical burns caused by e-cigarettes.

Since its introduction on the market in 2007, the number of reports on injuries caused by the ignition or explosion of electronic nicotine delivery systems (ENDS) has increased significantly. Two male patients have been treated at our burn center, the for ENDS-related injuries. Their batteries came into contact with metal objects stored in their pants pockets, resulting in a short circuit and finally ignition. In both patients, the combined flame and chemical burn wounds were initially irrigated with water upon arrival at the emergency department, leading to increased levels of pain. In our burn center, the wounds were extensively cleansed which led to a subsequent drop in NRS-scores. Laser Doppler Imaging showed a clear indication for surgery as both patients suffered a partial-thickness burn, with one patient having a patch of full-thickness burn as well. We swiftly performed an enzymatic debridement in both patients, followed by conservative wound management. Although enzymatic debridement is not generally recommended in the treatment of chemical burns, we successfully made use of this treatment option. Different authors advocate the use of mineral oils to irrigate or cover alkali burns, as contact between the chemical compounds and water can set off an exothermic reaction, leading to further injury. We believe that a hypertonic rinsing solution could be recommended as well in an emergency setting and we want to stress the importance of rapid removal of the chemical compounds in suspected chemical burns as well as swift debridement.

Lumbar Flap versus the Gold Standard: Comparison to the DIEP Flap.

BACKGROUND: The lumbar artery perforator flap is an excellent free flap for breast reconstruction whenever the deep inferior epigastric perforator (DIEP) flap is not an option. The main indication is a lack of abdominal bulk, often seen in young BRCA-positive women seeking prophylactic amputation and immediate reconstruction. METHODS: Between October of 2010 and July of 2016, a total of 661 free flap breast reconstructions were performed. The authors retrospectively analyzed patient demographics, perioperative parameters, and secondary corrections. RESULTS: Seventy-six lumbar artery perforator flaps were retained and compared with a cohort of 560 DIEP flaps. The average body mass index for lumbar patients was 23.8 kg/m, with a mean age at operation of 46.3 years. Average body mass index for DIEP patients was 25.2 kg/m, with a mean age at operation of 48.8 years old. Lumbar artery perforator flap weight was 504 g (range, 77 to 1216 g) on average versus 530 g (range, 108 to 1968 g) for the DIEP flaps. The amount of corrective procedures performed was very similar in both cohorts: 13 percent of the lumbar artery perforator and 12 percent of the DIEP patients underwent no procedures, 62 percent in both groups underwent one procedure, and 25 percent versus 27 percent underwent two or more procedures. Lipofilling was performed in 48 percent of lumbar artery perforator flaps compared with 57 percent of the DIEP flaps (p = 0.14). Mean volume injected was 98.0 cc and 125.1 cc for lumbar artery perforator and DIEP flaps, respectively (p = 0.071). CONCLUSIONS: The lumbar flap is a good alternative whenever a DIEP flap is not possible. Bilateral autologous reconstruction is possible even in very thin patients, and secondary corrections are comparable to those for the DIEP.

Author Correction: 20 Years of DIEAP Flap Breast Reconstruction: A Big Data Analysis.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Male-to-female gender affirmation surgery: breast reconstruction with Ergonomix round prostheses.

People with gender dysphoria are becoming more prevalent and more universally accepted. Social, hormonal, and surgical gender transition are able to substantially improve their quality of life. Various gender affirmation surgery (GAS) options are available to address gender dysphoria in the male-to-female (MtF) population, including facial and chest feminization, body contouring,  and genital surgery. While hormone replacement therapy may result in some degree of breast development, it is often insufficient to effectively result in an adequate female-like breast contour. The creation of a female chest is generally the first surgical step in the transition. The primary aim of this manuscript is to describe the surgical technique with ergonomix round prostheses used at our high-volume GAS center and to point out how anatomical differences between trans-female and cis-female patients impact surgery. Furthermore, we provide an overview of the demographic data and postoperative outcomes.

20 Years of DIEAP Flap Breast Reconstruction: A Big Data Analysis.

With every hospital admission, a vast amount of data is collected from every patient. Big data can help in data mining and processing of this volume of data. The goal of this study is to investigate the potential of big data analyses by analyzing clinically relevant data from the immediate postoperative phase using big data mining techniques. A second aim is to understand the importance of different postoperative parameters. We analyzed all data generated during the admission of 739 women undergoing a free DIEAP flap breast reconstruction. The patients' complete midcare nursing report, laboratory data, operative reports and drug schedule were examined (7,405,359 data points). The duration of anesthesia does not predict the need for revision. Low Red Blood cell Counts (3.53 × 106/µL versus 3.79 × 106/µL, p < 0.001) and a low MAP (MAP = 73.37 versus 76.62; p < 0.001) postoperatively are correlated with significantly more revisions. Different drugs (asthma/COPD medication, Butyrophenones) can also play a significant role in the success of the free flap. In a world that is becoming more data driven, there is a clear need for electronic medical records which are easy to use for the practitioner, nursing staff, and the researcher. Very large datasets can be used, and big data analysis allows a relatively easy and fast interpretation all this information.