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Breast Implantation clinical trials

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NCT ID: NCT03477565 Not yet recruiting - Breast Cancer Clinical Trials

Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery

BREASTAPE
Start date: April 3, 2018
Phase: N/A
Study type: Interventional

Over the last two decades in the field of oncology, the prevention, diagnosis, treatment and rehabilitation have reached a remarkable development, improving healing rates and reducing the number of deaths from cancer. The most frequent cancer in the female population is the breast one, which consequences can become disabling. In recent years, surgeons need to find more effective and less invasive treatments. Nowadays, despite the achievements, oncological surgery can cause side effects that cannot allow the return to normal life. Some of these problems are represented by the formation of edema and seroma, which can be handled by the physiotherapist through the manual lymphatic drainage and the application of an elastic tape. The elastic tape is used a lot in clinical practice, despite it lacks supportive evidence. The primary aim of the study is to verify the effectiveness of Kinesio Tex Tape in reducing edema and seroma formation following complex reconstructive breast surgery. The secondary goals are the evaluation of the quality of the scar, of the perception of pain, of the degree of satisfaction and disability. It is a controlled, monocentric, national, comparative, randomized, single-blind study. The sample size is 60 patients who undergo complex reconstructive breast surgery. Patients are divided into two groups: the experimental one (receiving standard treatment and Kinesio Tex Tape application) and a group of control (just receiving standard treatment). To evaluate edema and seroma, ultrasound is used; ultrasounds will be on the 1st, 15th and 30th postoperative days (T0, T1 and T2); Vancouver Scar Scale is used to define the quality of the scar (T0 and T2); to measure the subjective perception of pain and to evaluate the degree of patient satisfaction, two VAS scales are administered (the VAS scale for pain is administered at T0, T1 and T2, while the VAS scale for satisfaction is given at T1 and T2); Finally, to assess the degree of disability, the DASH Questionnaire is used (T0, T1 and T2).

NCT ID: NCT02551939 Completed - Breast Implantation Clinical Trials

Breast Fat Grafting Augmentation in Chinese Women

Start date: October 2013
Phase: N/A
Study type: Interventional

A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and well-being of patients during the preoperative and 1 year post operation.

NCT ID: NCT02438332 Completed - Breast Implantation Clinical Trials

Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

RANBI-I
Start date: December 2014
Phase: N/A
Study type: Observational

This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.

NCT ID: NCT02132572 Completed - Breast Implantation Clinical Trials

Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants

RANBI
Start date: March 2014
Phase: N/A
Study type: Observational

Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

NCT ID: NCT01244698 Completed - Bacterial Infection Clinical Trials

Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

Start date: November 2010
Phase: Phase 4
Study type: Interventional

Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.