SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

INTRODUCTION: Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.

Prophylactic use of levofloxacin during medicinal leech therapy.

BACKGROUND: Medicinal leech therapy is effective in establishing venous outflow in congested flaps and replants. However, its use is also associated with infections, especially from Aeromonas species. To prevent this nosocomial infection, levofloxacin has been established as prophylaxis during leech therapy in our hospital. OBJECTIVES: To study the implementation rate of a guideline, to study the effect of levofloxacin on possible Aeromonas infections, and to evaluate the financial impact of this preventive measure. SETTING: A retrospective analysis on all patients treated with Hirudo medicinalis between July 2007 and March 2011 was performed at the Ghent University Hospital, Belgium. METHOD: A list of patients treated with leeches was retrieved from the pharmacy database. Patient characteristics, date of start and stop of leech therapy were collected. Data on routine diagnostic cultures during leech therapy, date and type of clinical sample, while cultivated micro-organism with antibiotic susceptibility were obtained from the laboratory database. MAIN OUTCOME MEASURE: percentage implementation rate of a guideline, presence of Aeromonas infections, financial impact of levofloxacin prophylaxis. RESULTS: Fifty-one patients were treated with leeches. Forty-six (90.2 %) patients were treated according the guideline. Fourteen out of 51 patients (27.5 %) were suspected for postoperative wound infections. From them, 60 clinical samples were sent for microbiological analysis. These included exudates (26.7 %), peroperative samples (5.0 %), puncture fluid (1.7 %), blood cultures (3.3 %) or smears from burns (63.3 %). No Aeromonas species were cultivated. Comparison between period before and after implementation of levofloxacin prophylaxis revealed that levofloxacin prevents colonization or infection with Aeromonas species in relation to leech therapy. The direct cost for levofloxacin prophylaxis in the current study was 2,570 euro. Based on data obtained in a previous study, we presume that a minimum cost-saving of 20,500 euro was realised during the current study period by implementation of antimicrobial prophylaxis. CONCLUSIONS: This study demonstrates successful implementation of a guideline for levofloxacin prophylaxis during leech therapy. Following its introduction, no Aeromonas species related to the use of leeches were isolated as compared to 8.5 % in the baseline period.

Penile reconstruction: is the radial forearm flap really the standard technique?

BACKGROUND: The ideal goals in penile reconstruction are well described, but the multitude of flaps used for phalloplasty only demonstrates that none of these techniques is considered ideal. Still, the radial forearm flap is the most frequently used flap and universally considered as the standard technique. METHODS: In this article, the authors describe the largest series to date of 287 radial forearm phalloplasties performed by the same surgical team. Many different outcome parameters have been described separately in previously published articles, but the main purpose of this review is to critically evaluate to what degree this supposed standard technique has been able to meet the ideal goals in penile reconstruction. RESULTS: Outcome parameters such as number of procedures, complications, aesthetic outcome, tactile and erogenous sensation, voiding, donor-site morbidity, scrotoplasty, and sexual intercourse are assessed. CONCLUSIONS: In the absence of prospective randomized studies, it is not possible to prove whether the radial forearm flap truly is the standard technique in penile reconstruction. However, this large study demonstrates that the radial forearm phalloplasty is a very reliable technique for the creation, mostly in two stages, of a normal-appearing penis and scrotum, always allowing the patient to void while standing and in most cases also to experience sexual satisfaction. The relative disadvantages of this technique are the rather high number of initial fistulas, the residual scar on the forearm, and the potential long-term urologic complications. Despite the lack of actual data to support this statement, the authors feel strongly that a multidisciplinary approach with close cooperation between the reconstructive/plastic surgeon and the urologist is an absolute requisite for obtaining the best possible results.

Scrotal reconstruction in female-to-male transsexuals: a novel scrotoplasty.

BACKGROUND: One of the goals of genital construction in female-to-male transsexuals is the creation of an aesthetically acceptable result, both for phallus and scrotum, leaving minimal morbidity and recreating function. In the last 15 years, transsexuals have become more demanding, and scrotoplasty has received more attention than before. Traditional flaps for scrotal reconstruction in a biological male do not really apply in transsexuals: the labia majora seem to achieve the best results; still, they may not provide enough tissue and can be located much too posteriorly. METHODS: Since November of 1993, more than 300 scrotal reconstructions (and radial forearm flap phalloplasties) have been performed in female-to-male transsexuals by the authors' gender team. Based on the authors' large experience, they modified previous techniques and developed a novel scrotoplasty consisting of a V-Y advancement of the major labia together with a rotation of these superiorly based labial flaps. Refinements (to achieve better sensation and shaping) are described. Twelve months after the original operation, one testicle implant and erection prosthesis procedures were performed. RESULTS: No major complications related to scrotoplasty occurred in the authors' series. Patients were all pleased at short- or long-term follow-up with their scrotum, located in its natural position in front of the legs. CONCLUSION: The authors' novel scrotoplasty can become the ultimate surgical technique to reconstruct the scrotum in female-to-male transsexual patients, further improving the final cosmetic result, with the possibility of enhanced erogenous sensitivity.

Chest-wall contouring surgery in female-to-male transsexuals: a new algorithm.

BACKGROUND: In female-to-male transsexuals, the first surgical procedure in their reassignment surgery consists of the subcutaneous mastectomy. The goals of subcutaneous mastectomy are removal of breast tissue, removal of excess skin, reduction and proper positioning of the nipple and areola, and ideally, minimization of chest-wall scars. The authors present the largest series to date of female-to-male transsexuals who have undergone subcutaneous mastectomy. METHODS: A total of 184 subcutaneous mastectomies were performed in 92 female-to-male transsexuals, using the following five techniques: semicircular, transareolar, concentric circular, extended concentric circular, and free nipple graft. The technique used depended on the breast size and envelope, the aspect and position of the nipple-areola complex, and the skin elasticity. To best meet the goals of creating a normal male thorax, the authors have developed an algorithm to aid in choosing the appropriate procedure. RESULTS: The overall postoperative complication rate was 12.5 percent (23 of 184 subcutaneous mastectomies), and in eight of these cases (4.3 percent), an additional operative intervention was required because of hematoma, infection, and/or wound dehiscence. Despite this low complication rate, additional procedures for improving aesthetic results were performed on 59 breasts (32.1 percent). The semicircular and concentric circular techniques produced the highest rating of the overall result by patient and surgeon, whereas the extended concentric circular technique produced the lowest rating. CONCLUSIONS: Skin excess and skin elasticity are the key factors in choosing the appropriate technique for subcutaneous mastectomy, which is reflected in the algorithm. Although the complication rate is low and patient satisfaction is high, secondary aesthetic corrections are often indicated.

A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction.

BACKGROUND: The ideal dermal filler should be nonpermanent but with a durable effect lasting between 1 and 2 years, which is not the case with the resorbable fillers that are currently available. Evolence30 is a new, porcine-derived collagen gel based on the Glymatrix cross-linking technology, which results in a more natural and longer-lasting collagen product. METHODS: In this first clinical trial of Evolence30 (30 mg/ml), the safety and efficacy of this new filler were tested and compared with those of Zyplast (bovine cross-linked) collagen, after treatment of nasolabial folds in 12 volunteers. Safety assessments included two hypersensitivity tests, physical examination of injections sites, punch biopsies for histopathology, adverse events, and blood sample analysis. The seven-grade, validated Modified Fitzpatrick Wrinkle Scale was used by three independent blinded assessors to evaluate efficacy. RESULTS: No treatment-related adverse events were reported. Only transient erythema was observed in both treated sides, and there were no abnormal laboratory findings. None of the sera contained immunoglobulin (Ig) M, IgA, or IgE antibodies against porcine collagen at any time during the study. Initially, Evolence30 and Zyplast improved wrinkle severity to a similar extent. However, in an average follow-up of 18 months, assessment by the blinded assessors showed that the treatment effect on the Evolence30-treated side was superior in 9 of the 11 participants who were treated (p = 0.022). CONCLUSIONS: Evolence30 is a new, porcine-derived collagen product based on the Glymatrix cross-linking technology that enables a safe and effective correction of the nasolabial folds. This correction lasts significantly longer than that with Zyplast.

Rehabilitation of burn injured patients following lightning and electrical trauma.

Electrical burn injuries are complicated because of damage to many structures including: blood vessels, muscles, nerves, tendons, bone and skin. Surgeons must confront many problems such as wound healing coverage, scarring, loss of nerve and tendons, progressive joint stiffness and amputation. The goals of burn therapists are to achieve wound healing, functional recovery, and good cosmetic results. Rehabilitation is both preventive and therapeutic and is a fundamental part of managing these patients. In this article, rehabilitation is discussed with emphasis on the following: pain management, wound coverage, positioning, splinting, and exercises (range-of-motion and ambulation). The treatment and prevention of hypertrophic scarring is evaluated. Finally, the use of engineering and assistive technologies for rehabilitation of the electrical burn injured patient is discussed. Successful management of electrical burn injured patients involves communication among the different burn specialists, such as surgeons, anesthesiologists, neurologists, nurses, and kinesitherapists; engineers from the garments/prostheses companies; psychologists; and the patient him/herself.

The "Gent" consensus on perforator flap terminology: preliminary definitions.

Due to its increasing popularity, more and more articles on the use of perforator flaps have been reported in the literature during the past few years. Because the area of perforator flaps is new and rapidly evolving, there are no definitions and standard rules on terminology and nomenclature, which creates confusion when surgeons try to communicate and compare surgical techniques. This article attempts to represent the opinion of a group of pioneers in the field of perforator flap surgery. This consensus was reached after a terminology consensus meeting held during the Fifth International Course on Perforator Flaps in Gent, Belgium, on September 29, 2001. It stipulates not only the definitions of perforator vessels and perforator flaps but also the correct nomenclature for different perforator flaps. The authors believe that this consensus is a foundation that will stimulate further discussion and encourage further refinements in the future.

The latero-central glandular pedicle technique for breast reduction.

The relatively high number of complications and disadvantages of the conventional techniques in breast reduction combined with our expertise in restoring sensation in breast reconstructive procedures, led to the development of a new technique that was crystallised from the traditional techniques and is able to overcome most of their disadvantages. The key issue of the technique is that the nipple is vascularised and innervated on a column of glandular tissue that remains in contact in its posterior part with the pectoralis muscle and its perforators and in its lateral aspect to the lateral pillar of breast tissue. Due to the ptosis that develops during the process of hypertrophy, this column will gain sufficient length to be turned upwards into the new position of the nipple. Resection of glandular tissue is performed cranially, medial and inferior to this column. Undermining of the skin is reduced to an absolute minimum and glandular resections are always performed in the shape of a wedge. In this way, undermining of the breast gland over the pectoralis muscle is avoided. The glandular pedicles are sutured together after loosely fitting the glandular cone with the nipple into its new position. The long term results of the first 68 cases were reviewed and compared to our experience with the superior dermal pedicle technique combined with the vertical scar as described by Lassus and later by Lejour. Due to increased vascularisation of the nipple-areolar complex (NAC), wound complications were markedly reduced with the new technique. Sensation in the NAC was preserved in almost all cases. There was a high satisfaction about the obtained aesthetical results in regard to shape and volume. Increased viability of the NAC, a reduced rate of wound complications and preservation of sensation in NAC are the main advantages of this technique. Additionally, flattening of the NAC is avoided by the support by glandular tissue behind the NAC that improves projection and hereby the aesthetic conic appearance of both breast and nipple.

Ball lightning burn.

Ball lightning is a rare physical phenomenon, which is not yet completely explained. It is similar to lightning but with different, peculiar characteristics. It can be considered a mix of fire and electricity, concentrated in a fireball with a diameter of 20-cm that most commonly appears suddenly, even in indoor conditions, during a thunderstorm. It moves quickly for several meters, can change direction, and ultimately disappears. During a great storm, a 28-year-old man and his 5-year-old daughter sustained burn wounds after ball lightning came from the outdoors through a chimney. These two patients demonstrated signs of fire and electrical injuries. The father, who lost consciousness, sustained superficial second-degree burn wounds bilaterally on the zygomatic area and deep second-degree burn wounds on his right hand (total body surface area, 4%). His daughter demonstrated superficial second-degree burn wounds on the left part of the face and deep second-degree and third-degree burn wounds (total body surface area, 30%) on the left neck, both upper arms, and the back. In this article, the authors report the first two cases of burn injuries resulting from ball lightning contact indoors. The literature on this rare phenomenon is reviewed to elucidate the nature of ball lightning. Emphasis is placed on the nature of injuries after ball lightning contact, the therapy used, and the long-term complications.

Minimal access cranial suspension lift: a modified S-lift.

There is a strong trend at hand toward less dramatic facial rejuvenation surgery. Most of the authors' patients want a cosmetic improvement but not at the cost of prolonged disfigurement or a high risk of complications. In 1999, a very simple but effective rhytidectomy technique, termed an S-lift, was described in the literature and was adopted by the authors. Its basic principle is the suspension of sagging facial features by a strong, permanent purse-string suture. The procedure is performed with the patient under local anesthesia. Significant modifications were applied to the incision, to the purse-string suture anchoring site, and to the direction and shape of the skin excision. The authors named the modified procedure the minimal access cranial suspension lift to specifically describe the concept of the technique. Through an inverted L-shaped preauricular incision with extension below the sideburn, a limited skin undermining is performed. Two strong, permanent purse-string sutures are woven into the superficial musculoaponeurotic system tissues in a vertical U and an oblique O shape, initiating from a strong anchorage in the deep temporal fascia at the level of the helical crus. Tying these sutures produces a very powerful vertical correction of descended facial features that acts mainly on the jowls and the upper neck. The procedure can be extended by continuing the dissection over the malar fat pad, placing a third vertical purse-string suture with strong action on the nasolabial groove, and vertically repositioning the midfacial volumes. During 20 months, pleasing results and a very low complication rate were obtained in 88 consecutive patients with a mean age of 551/2 years. In this article, the authors provide a detailed description of the anesthetic and surgical technique, a demonstration of the results in different patient age categories, and a discussion comparing the minimal access cranial suspension lift with other types of facial rejuvenation procedures.