Pascale Mutti Tacani

Histamine iontophoresis on the viability of random skin flap in rats

PURPOSE To evaluate the effects of the histamine iontophoresis on the random skin flap viability in rats. METHODS Sixty adult male Wistar rats were used. A cranially-based dorsal skin flap measuring 10 x 4 cm was raised and a plastic barrier was placed between the flap and its bed. After the surgical procedure, the animals were randomized into four groups (G1-G4) (n=15 each group) as follows: G1 (control)--sham electrical stimulation, G2 (electrical stimulation)--direct current electrical stimulation, G3 (histamine)--histamine and sham electrical stimulation, and G4 (histamine iontophoresis)--transdermal iontophoresis of histamine. In all groups the procedures were performed immediately after the surgery and on the two subsequent days. The percentage of flap necrosis was measured on the seventh postoperative day. RESULTS The mean and the respective standard deviation of the percentage of flap necrosis areas were as follows: G1 (control) - 47.87 +/- 9.13%, G2 - 51.49 +/- 8.19%, G3 - 46.33 +/- 8.32% and G4 - 30.82 +/- 11.25%. The G4 group presented a significantly smaller amount of flap necrosis when compared to the other groups (p<0.001). CONCLUSION The topical administration of the histamine by iontophoresis was effective to increase the viability of the random skin flaps in rats.

Mechanical stimulation improves survival in random-pattern skin flaps in rats.

This was a study on the effects of 3-MHz ultrasound at 16- and 100-Hz pulse repetition frequencies on angiogenesis and viability of random-pattern skin flaps in rats. A cranially-based dorsal skin flap was raised in 60 EPM-Wistar rats, which were randomly divided into four groups: control, sham, 16-Hz and 100-Hz groups. The mean percentage of necrosis was as follows: control, 42% ± 13%; sham, 18% ± 13%; 16-Hz group, 13% ± 10%; and 100-Hz group, 15% ± 7%, with significant differences between the control and the other groups (p < 0.001). The mean vascular density was as follows: control, 5% ± 2%; sham, 7% ± 2%; 16-Hz group, 21% ± 4%; and 100-Hz group, 24% ± 10%, with significant differences between control and ultrasound groups, and between the sham and ultrasound groups (p < 0.001). Both ultrasound treatments (16- and 100-Hz PRFs) induced angiogenesis, and sham and ultrasound treatments improved viability of random-pattern skin flaps in rats.

The effects of transcutaneous electrical nerve stimulation on tissue repair: A literature review

BACKGROUND Transcutaneous electrical nerve stimulation (TENS) consists of a generic application of low-frequency, pulsed electrical currents transmitted by electrodes through the skin surface. It is a therapeutic modality that is nonpharmacological, noninvasive, inexpensive, easy to use and widely applied in clinical practice. OBJECTIVE To narratively review the scientific evidence of the effects of TENS on tissue repair with respect to wound healing, skin flap viability and tendinous repair. METHODS The study was conducted using the MEDLINE, Lilacs and Scielo databases, without limit to the period of publication, and was completed in November 2011. Inclusion criteria were randomized or nonrandomized, controlled or noncontrolled clinical trials, and experimental trials involving rats subjected to TENS for tissue repair. RESULTS Thirty articles on tissue repair were found and, among these, 14 reported on wound healing, 14 reported on skin flaps and two analyzed tedinous repair. DISCUSSION It was suggested that TENS stimulates skin wound healing and tendon repair, as well as the viability of random skin flaps. Such effects may be due to the release of substance P and calcitonin gene-related peptide, which would increase blood flow and, consequently, hasten the events leading to tissue repair. CONCLUSIONS Based on the scientific evidence regarding the effects of TENS on tissue repair, the findings of the present literature review were inconclusive because data from the randomized controlled clinical trials were insufficient to confirm such effects.

Characterization of symptoms and edema distribution in premenstrual syndrome

Background Premenstrual syndrome is a group of symptoms linked to the menstrual cycle, and edema is among these symptoms. Physiotherapy is often sought by many patients for the treatment of edema; however, for an adequate prescription of physiotherapeutic procedures, the distribution of edema throughout the body has yet to be characterized. Objective To determine the most frequent symptoms and body regions that present with edema in women during the premenstrual period. Subjects and methods Sixty women with a mean age of 24.6±4.7 years were evaluated during their premenstrual (between days 21 and 28) and menstrual period (between days 1 and 3), and the collected data included body mass, height, biotype (body-fat distribution), face, breast, limb-circumference measurements, and limb-volume estimate, and an adapted version of the Premenstrual Symptoms Screening Tool was used. Statistical analysis was performed using Student’s t-test and the test for equality of two proportions (P≤0.05). Results Premenstrual syndrome was identified in 91.7% of the women, and the most frequent symptoms were irritability (73.33%) and physical symptoms, including swelling (65%), and anxiety (58.3%). Edema was detected in the following areas: facial, epigastric, mammary, umbilical, and pubic, the mid-third of the arms, distal forearm, in both thighs and in the mid-third of the legs determined by circumference measurements, and in both upper and lower limbs, according to the estimated volume. Conclusion In this study population, the most frequent symptoms were irritability, physical symptoms, and anxiety, with distribution of edema in the face, breast, abdomen, pubic area, distal upper limb, and proximal lower limb.

Medical devices registration by ANVISA (Agência Nacional de Vigilância Sanitária)

Dear Editor, The term “medical devices” covers a wide range of health or medical instruments used directly or indirectly in medicine, dentistry, physical therapy, and laboratory practice for the diagnosis, rehabilitation, therapy, and monitoring of human beings, as well as for aesthetic purposes. The National Health Surveillance Agency (Agencia Nacional de Vigilância Sanitaria – ANVISA)1 is responsible for the registration of medical devices in Brazil and assigns a unique 11-digit identification number to each device, according to specific resolutions. According to ANVISA,1 all medical devices are regulated by the Brazilian Ministry of Health, under Article 12 of Law No. 6360 of September 23, 1976, published in the Official Gazette of September 24, 1976. This Article regulates the manufacture, use, and sale of medical devices in Brazil. All medical devices have to be registered and/or listed with ANVISA. Listing is the first step in the registration process of all medical devices. This is a simple process that applies to medical devices classified according to the first paragraph of Article 25 of Law No. 6360 as Class I and Class II, which do not require registration under Resolution RDC ANVISA 24 of May, 1999. On the other hand, some medical devices require registration, even if classified as Class I or Class II, because of the potential risk involved, as indicated in Resolution RDC ANVISA 185 of October 22, 1999, and other complementary regulations also used in this process. The requirement for medical device registration and/or listing with ANVISA is determined by the classification of the device into four risk classes (I to IV) based on 18 classification rules. Classes I, II, III and IV represent low-, medium-, high- and very-high-risk devices, respectively. Thus, medical devices classified as Class I and Class II may or may not require registration depending on their use, because they pose a low risk to the patient. Class III and Class IV devices require listing and registration, and all the parameters and specifications of the device have to be given during the registration process. The classification rules for the registration of medical devices are based on the evaluation of risks arising from the application and use of the devices. Medical devices used in physical therapy are considered active devices, meaning that a power supply is required for their operation. These devices can be classified based on four rules, of which the most important one (Rule 9) refers to “active therapeutic devices intended to deliver energy to or exchange energy with the human body”, including electrophysical agents used in the clinical practice to facilitate wound healing, analgesia, edema reduction, and modulation of the inflammatory process. Most of the electrophysical instruments used in physical therapy for tissue repair are classified as Class II devices and only require to be listed. Examples of Class II devices include equipment used in ultraviolet phototherapy, ultrasound therapy, pulsed electromagnetic field therapy, electric stimulation therapy, laser therapy, and light-emitting diode therapy. Regardless of their therapeutic use and classification, all medical devices should necessarily be registered with the provision of clear specifications, and their safety for use in the clinical practice should be determined on the basis of clinical trials. Therefore, even devices for aesthetic treatments or those used by technicians, such as estheticians, should have reliable operating parameters, allowing them to be tested in scientific studies. The search for agents that can influence the wound-healing process by accelerating the different phases of wound healing and reducing healing time, and that can improve functional and aesthetic results, is still a challenge in the field of surgery. Experimental studies have indicated that the use of medical devices have a beneficial effect on the healing of skin wounds, contributing to the modulation of the inflammatory process,2,3 stimulation of angiogenesis,2,4 proliferation of fibroblasts2,3,5 and myofibroblasts,6–8 deposition of collagen,3 and proliferation of keratinocytes.9 From these studies, it was possible to advance to clinical trials and adjust the specifications of these devices for use in clinical practice. As an example, there is an electrophysical device available in the market, called the “high-frequency machine”, which has been used for many years for facial and body aesthetic treatments. The literature and manufacturers suggest that this device produces therapeutic effects similar to those obtained from the topical application of ozone, and is indicated for the healing of skin wounds, surgical wound dehiscence, and treatment of fungal lesions.10–15 However, scientifically rigorous studies are necessary to determine the veracity of these claims, because the reported performance of this device is based on unreliable studies, and to date no study on this device has been published in the peer-reviewed medical literature. According to ANVISA, the high-frequency machine is classified as a Class I device, meaning that it is a device for aesthetic treatments and is considered to pose a low risk to the patient. Therefore, the manufacturer is not required to register this device and disclose all technical specifications in order to standardize its applications, even though there may be risks and contraindications associated with its use. Thus, like other medical devices for therapeutic use, the registration and control of the specifications and parameters of such a device would be of considerable importance. Moreover, the registration of all medical devices should be mandatory. All these biophysical agents have specific indications and contraindications, have the potential to produce skin lesions, such as burns, and may negatively impact the health of patients with pacemakers, malignant tumors or thrombophlebitis, among other things. On the basis of the classification system (classes I to IV) for medical devices, ANVISA does not require scientific studies to be performed to determine the actual effects and risks of Class I and Class II devices. This trivializes their use and allows non-medically qualified practitioners to operate them. Therefore, the goal of this Letter to the Editor is to alert the community to the current system of risk categorization of medical devices used by ANVISA, which can result in losses and harm to the patient caused by the use of a device. In conclusion, we believe that it is important to call the attention of health officials to the need for standardization of the parameters and specifications of medical devices, so that their therapeutic use can follow guidelines developed on the basis of scientifically rigorous studies, providing increased safety to patients treated with such devices.

Drenagem linfática manual nos sintomas da síndrome pré-menstrual: estudo piloto

A sindrome pre-menstrual e um complexo de sintomas - dentre os quais o edema pre-menstrual - entre o 10o e o 14o dias que antecedem a menstruacao e cessam no inicio do fluxo menstrual. A tecnica de drenagem linfatica manual (DLM) drena o excesso de liquido acumulado, atua no edema e poderia aliviar esses sintomas. O objetivo deste estudo piloto foi verificar o efeito da DLM no alivio dos sintomas da sindrome pre-menstrual e a qualidade de vida relacionada a saude em quatro mulheres jovens. O estudo foi realizado ao longo de dois ciclos menstruais, ciclo 1 sem intervencao terapeutica, e o segundo ciclo, com aplicacao da tecnica de DLM. As participantes foram avaliadas, no inicio do ciclo 1 e final do ciclo 2, por anamnese, mensuracao de estatura e massa, estimativa da composicao corporal, diario de sintomas e quanto a qualidade de vida relacionada a saude, pelo WHOQoL-bref. Os resultados mostraram reducao significativa apenas do diâmetro de abdome superior nos niveis xifoide e umbilical; as medias total e individual dos sintomas do diario reduziram-se, porem sem significância, tal como ocorreu no aumento dos escores no WHOQoL-bref. A drenagem linfatica manual foi eficaz na diminuicao de um sintoma da sindrome pre-menstrual, o edema em regiao superior abdominal, e nao alterou a qualidade de vida dessas jovens.

Abordagem fisioterapêutica do linfedema bilateral de membros inferiores

INTRODUCTION: Lymphedema is the accumulation of protein interstitial fluid as a result of impaired lymphatic function, recommended the use of Complex Physical Therapy as a treatment. OBJECTIVE: To determine the effects of Complex Physical Therapy on the treatment and maintenance of bilateral lower limb lymphedema. METHODS: Seven patients, aged between 59 and 85 years, with bilateral lower limb lymphedema participated in this study. The study consisted of four periods: (1) Control period - first physiotherapeutic evaluation (the patients did not receive any treatment at this stage); (2) Treatment period (reduction stage) - second evaluation and physiotherapeutic treatment (complex physical therapy); (3) Maintenance period - third evaluation, patient discharge, and complex physical therapy; and (4) follow-up period - evaluation of the last stage. The time interval bewteen evaluations was 10-12 weeks. The leg volume was calculated using leg perimeter data and the formula for the volume of a truncated cone, and ankle swelling was measured using the figure-of-eight method. RESULTS: The mean ankle measurement and leg volume at the first, second, third and fourth evaluations were 62.32 cm and 6233 ml, 62.57 cm and 6308 ml, 56.75 cm and 5505 ml, and 57 cm and 5566 ml, respectively. Figure Eight measurements and leg volumes were significantly lower at the third and fourth evaluations than at the first and second evaluations (p < 0.001), showing a significant reduction in volume and stabilization of the lymphedema during the maintenace period. CONCLUSION: The complex physical therapy was efficient in the treatment and maintenance of bilateral lower limb lymphedema.

MASSA CORPORAL, IMAGEM CORPORAL E DESEJO POR TRATAMENTOS ESTÉTICOS NAS DIFERENTES FASES DO CICLO MENSTRUAL

Objective: analyze the body weight, body image and the desire for aesthetic treatments during the follicular and luteal phases of the menstrual cycle. Methods: this is a prospective longitudinal clinical trial, which forty women were followed for a complete menstrual cycle and evaluated by two times: Follicular Phase and Luteal Phase, for middle of the Body Shape Questionnaire (BSQ) and the Scale Figures Silhouettes and questioned about the desire for aesthetic treatments quantified by Visual Numeric Scale (VNS), during the months of january to may 2012, in the Physical Therapy of Sao Paulo City University. Results: there was an increase in body mass (p < 0.001) and the Scale Figures Silhouettes FF for FL (p = 0.058). Conclusions: increased body mass and impaired body image, however, there was no change in body image and the desire for aesthetic treatments in the different phases of the menstrual cycle.