BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial.

INTRODUCTION: Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). METHODS AND ANALYSIS: This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. TRIAL STATUS: Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021. TRIAL REGISTRATION NUMBER: NCT02339779.

Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial.

INTRODUCTION: Early breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective. METHODS AND ANALYSIS: A multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media. TRIAL REGISTRATION NUMBER: NCT02790021; Pre-results.

Clinical effects of transparent facial pressure masks: A literature review.

BACKGROUND: Severe facial hypertrophic scars are known to severely impact emotional well-being. Pressure therapy by means of transparent face masks has been used for almost 40 years, but evidence about the clinical effects remains sparse. OBJECTIVES: To provide a summary on the efficacy of transparent face masks in the treatment of facial hypertrophic scars. METHODS: A literature search was conducted in PubMed, MEDLINE, and Cochrane databases through 1 January 2018. Articles describing the clinical effects of facial pressure therapy for remodeling the face after trauma or surgery with a validated tool were included. This review included studies of participants treated with facial hypertrophic scars, both minors and adults. RESULTS: Three articles involving 33 patients were selected for inclusion. Two studies described statistically significant improvement in facial scars measured by durometer, ultrasound, and the Patient and Observer Scar Assessment Scale (POSAS). CONCLUSIONS: Facial pressure masks have been shown to deliver significant improvement in facial scars, measured by both subjective and objective tools. However, only three studies could be included in this literature review. Also, because of considerable limitations of the studies, it remains difficult to draw substantial conclusions about the efficacy of transparent face masks. CLINICAL RELEVANCE: This literature review provides a summary of the current evidence on the subjectively and objectively measured clinical effects of transparent face masks in the treatment of facial scars, highlighting the need for further research on this topic.

Manual fabrication of a specialized transparent facial pressure mask: A technical note.

BACKGROUND AND AIM: The objective of this study was to describe the manual fabrication of a transparent facial pressure mask for treating facial deformities. The mask combines the use of a silicone inner liner and mechanical pressure in the facial region. TECHNIQUE: A negative mold is formed by covering the face with plaster. Manipulation of soft tissue is a crucial part in this process. After hardening and removal of the negative mold, the positive mold is formed and dried. Next a rolled silicone sheet is placed over the positive mold in a vacuum environment. Subsequently, the silicones are vulcanized. Then the rigid outside of the mask is created. The silicone inner liner and outside shell are then affixed. DISCUSSION: This described technique results in accurate facemasks with precise fitting. During therapy, the mask is adjusted multiple times to keep excellent fit, as remodeling of scars and deformities takes place. CLINICAL RELEVANCE: Facemasks are a reputable therapeutic modality to reduce excessive facial scarring. They require excellent fitting to give pleasing results. To provide a better understanding of facemask therapy, this study describes the manual fabrication technique.

Duration of Scar Maturation: Retrospective Analyses of 361 Hypertrophic Scars Over 5 Years.

OBJECTIVE: Maturation remains the least understood phase of wound healing; estimates of maturation time are broad and inaccurate. A more precise estimation of maturation time could influence scar therapy and give insight to the wound healing cascade. The objective of this study was to assess the mean time between onset and complete maturation of hypertrophic scars. METHODS: This retrospective study was performed in an outpatient clinic of the Maastricht University Medical Center exclusively focused on scar treatment; 361 patients with a hypertrophic scar were included between September 2010 and December 2015. MAIN OUTCOME MEASURES: Date of onset and date of complete maturation were documented in patients' medical files. Patients were divided into three patient groups: <30 years, 30-55 years, and >55 years. Different scar causes and scar therapies were analyzed in relation to maturation time. MAIN RESULTS: These results reveal statistically significant differences (P < .05) in mean maturation time between the <30 (35.76 months) and >55 patients (22.53 months) and between >55 and 30-55 year old patients (34.64 months). Significant differences in mean maturation time were also found between scars treated with pressure therapy (23.20 months) and combination therapy (30.59 months), silicone therapy (35.51 months), injection therapy (46.43 months), and other therapies (41.31 months). No significant differences in maturation time were found relative to scar cause. CONCLUSIONS: This study shows that hypertrophic scars take significantly more time to completely maturate than previously believed, and older patients show the fastest healing. Further, scars treated with pressure therapy maturate fastest.

Autologous Fat Transfer as a Treatment for Peripheral Neuropathic Pain without Apparent Cause.

Neuropathic pain has a far-reaching effect on the daily lives of patients. Recently, autologous fat transfer (AFT) has demonstrated promising results in patients with painful scars or after neuroma excision. However, there is a subgroup of patients who do not show any apparent cause for the pain. We hypothesized that in these patients, AFT alone in the area around the affected nerve might lead to beneficial results. Patients with clearly demarcated neuropathic pain and who had exhausted all other treatment options were referred by a pain specialist. Fourteen patients who met the inclusion criteria received AFT in the area of the affected nerve. Pain scored on the visual analog scale, patient satisfaction, and quality of sleep were recorded before and after surgery. To investigate long-term effects, a second follow-up was planned at least 1 year later. Patient satisfaction was 93% after the first follow-up and 86% after more than 1 year. The mean VAS score was 7.4 before surgery and significantly decreased to 3.8 after autologous fat grafting (P < 0.0001) and 4.3 (P = 0.0017) at long-term follow-up. The quality of sleep improved in 50% of the patients, whereas the remainder indicated no difference. No complications were registered. The results show that AFT alone, even over a longer period of time and in patients refractory to multiple treatment modalities, can be useful to treat peripheral neuropathic pain without apparent cause. For definitive evidence, a larger prospective study is warranted.

Validity and Reliability of Three-Dimensional Imaging for Measuring Breast Cancer-Related Lymphedema in the Upper Limb: A Cross-Sectional Study.

Background: In the past, measurement of upper limb lymphedema was done by water displacement (WD), which is frequently cited as the gold standard. For various reasons, however, the use of WD is restricted in clinical settings. A more precise and easy-to-use method would be favorable. The high precision of three-dimensional (3D) imaging in comparison to WD has already been reported for healthy subjects. The aim of this study is to determine the validity and reliability of 3D imaging by comparing it to the WD method in women with unilateral upper limb lymphedema. Methods and Results: Thirty-nine women with unilateral breast cancer-related lymphedema (BCRL) were included, of which 37 completed two volume measurement techniques (3D and WD) on the BCRL and contralateral healthy arm. Slightly larger volumes were measured by the WD method in healthy arms (+9.8 mL; p = 0.058) and also in BCRL arms (+18.5 mL; p < 0.001). All measurements were performed twice by the same researcher to evaluate reliability. There was no significant difference between the two measurements for healthy arms (p = 0.323) or BCRL arms (p = 0.807) in 3D imaging. Bland-Altman plots showed a high limit of agreement between the single measurements. 3D imaging had a high intrarater reliability (Intraclass Correlation Coefficient = 0.999). Conclusion: Results show that 3D imaging is an innovative method for measuring upper limb volume in BCRL patients. Even though image processing is time consuming, 3D imaging combines high reproducibility with high precision. By software automation, this technique could easily be integrated into clinical routine. It is for this reason that we would recommend implementing the Vectra 3D imaging technique for measurement of BCRL.

Quality of Life Questionnaires in Breast Cancer-Related Lymphedema Patients: Review of the Literature.

PURPOSE: Lymphedema of the arm is one of the most common and underestimated side effects of breast cancer treatment. It is known to negatively affect the quality of life (QoL) in breast cancer survivors. However, there are multiple questionnaires used to measure QoL in lymphedema patients. The current study aimed to determine the most complete and accurate questionnaire. METHODS: A systematic literature search in Cochrane Library database CENTRAL, MEDLINE, and EMBASE was conducted in August 2016 by two independent researchers. The strategy used for the search was: (("Lymphedema"[Mesh]) AND ("Quality of life"[Mesh])). All QoL questionnaires for patients with breast cancer-related lymphedema (BCRL) were included. An overview of the assessed QoL domains and arm symptom-specific questions was made, to assess the most complete and accurate questionnaire. RESULTS: A total of 142 studies were identified, of which 49 met the inclusion criteria and 15 different questionnaires were extracted. The Lymphedema Quality of Life Inventory (LyQLI), assesses all QoL domains, except for the possibility of wearing the clothes of choice, and assess all specific arm symptoms. The Lymphedema Functioning, Disability, and Health (Lymph-ICF) Questionnaire assesses all QoL domains, except for sexual functioning, and does assess all specific arm symptoms. CONCLUSION: According to the results obtained, the LyQLI and Lymph-ICF questionnaires were the two most complete and accurate questionnaires to assess QoL in patients with BCRL, because these questionnaires assess the largest number of QoL domains and specific arm symptoms.

A new treatment for reliable functional and esthetic outcome after local facial flap reconstruction: a transparent polycarbonate facial mask with silicone sheeting.

BACKGROUND: Facial flap surgery predominantly leads to good functional results. However, in some cases, it can cause unsatisfactory esthetic results. They include persistent erythema, pincushioning, and development of hypertrophic scars. Conservative, reliable treatment for facial flaps is lacking. Pressure and silicone therapy have proven to result in significant improvement in scar erythema, pliability, and thickness in postburn hypertrophic scars. By combining these therapies in a facial mask, the esthetic outcome of facial flaps could be improved. In this retrospective study, the efficacy of a unique transparent face mask containing silicone sheets on the esthetic outcome of postsurgical facial flaps is assessed. METHODS: Twenty-one patients were assigned to facial pressure mask therapy after they underwent facial flap surgery between July 2012 and September 2015. Patients were treated for a mean duration of 46 weeks. The effects of pressure mask therapy were examined by means of the Patient and Observer Scar Assessment Scale (POSAS). RESULTS: All POSAS components showed a reduction between start and end of therapy, while itchiness, pigmentation, pliability, thickness, and relief of the flap improved significantly (P < 0.05). Mean total and patient score showed significant reduction between start and end of therapy. CONCLUSIONS: This study shows that a facial pressure mask layered with silicone results in noticeable flap improvement with a long-lasting result. Level of Evidence: Level III, therapeutic study.

Outcomes of vascularized versus non-vascularized lymph node transplant in animal models for lymphedema. Review of the literature.

Lymph node transfer has been performed to treat lymphedema for several years. The goal of this procedure is to provide a bridge between the lymphatic system distal and proximal to the lymph node dissection. There is a lack of consensus about the necessity of an additional vascular anastomosis for the transplanted lymph nodes. A systematic literature search in Cochrane Library database CENTRAL, MEDLINE, and EMBASE of animal studies using lymph node transplantation with and without additional vascularization was performed in March 2016. The strategy used for the search was: (("Models, Animal"[Mesh]) AND (("Lymphedema"[Mesh]) OR "Lymph Nodes"[Mesh]) OR "Lymph Node Excision"[Mesh])) AND ((vascularized lymph node transfer) OR ((non-vascularized lymph node transfer) OR lymph node graft)). The primary outcomes were: survival of transplanted lymph node and lymphatic vessel regeneration. Sixteen studies were included. Vascularization and the use of growth factors were significantly associated with lymph node survival. Lymphatic vessels regeneration was independent from vascularization. According to the results of the current study, additional vascular anastomosis might improve the transplanted lymph node survival. Further studies in both experimental and clinical setting are needed in order to support it. J. Surg. Oncol. 2017;115:32-36. © 2016 Wiley Periodicals, Inc.

Mechanism of Action, Efficacy, and Adverse Events of Calcium Antagonists in Hypertrophic Scars and Keloids: A Systematic Review.

BACKGROUND: Pathological scars often cause major cosmetic and functional consequences, which make effective treatment important. Intralesional therapies are widely used, with corticosteroid injection considered to be first choice. An emerging and promising treatment option is the calcium antagonist verapamil. OBJECTIVE: To provide a comprehensive evidence-based review of current evidence on mechanism of action, efficacy, and adverse events of calcium antagonists in treatment of hypertrophic scars and keloids. METHODS AND MATERIALS: A Cochrane Library and PubMed search was performed for the literature pertaining to treatment with calcium antagonists in pathological scars. Articles were categorized into two groups: mechanism of action or efficacy and adverse events. RESULTS: Six in vitro studies were included in the first subgroup. Calcium antagonists have been found to reduce extra cellular matrix production, induce procollagenase synthesis, and inhibit interleukin-6, vascular endothelial growth factor, and proliferation of fibroblasts. Eight studies with a median level of evidence of 3.5 (range: 2-4) were included in the second category. A good efficacy with no major side effects was reported for calcium antagonists. CONCLUSION: Important methodological shortcomings of the available literature were identified. Interesting results have been reported, but further large scale, high-quality studies are needed to optimally evaluate efficacy of treatment with calcium antagonists.