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.

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.

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.

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.