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Seroma clinical trials

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NCT ID: NCT03512639 Completed - Seroma Clinical Trials

Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy

HOM
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Arnica montana and Bellis perennis for Prevention of Seroma Following Mastectomy.

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: NCT03433937 Terminated - Quality of Life Clinical Trials

Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.

NCT ID: NCT03344575 Completed - Laparoscopy Clinical Trials

Peritoneal Bridging in Laparoscopic Ventral Hernia Repair

BriClo
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Laparoscopic ventral hernia repair (VHR) is usually performed by reducing the contents in the hernia sac from the abdominal cavity and then covering the defect from the inside with a mesh, i.e. Intraperitoneal Onlay Mesh (IPOM). This means that the hernia sac is left in situ anterior to the mesh. This may, however, predispose for the development of fluid in the hernia sac, i.e. seroma. The risk of seroma development may be reduced if a the defect is closed before the mesh is applied. Closing the defect may, however, cause tension and pain from the abdominal wall. Instead of closing the defect, the part of the peritoneum constituting the hernia sac may be used for closing the defect. In this case, the peritoneum is dissected from the edges of the hernia sac and then used as a flap that is fixated to the edges of the hernia sac on the opposite side. In order to evaluate whether peritoneal bridging reduces the seroma development following ventral hernia repair, we are undertaking a double-blind randomized controlled trial comparing conventional closure of the hernia defect with peritoneal bridging. The goal is to randomize 50 patients undergoing laparoscopic ventral hernia to conventional closure or closure of the defect with peritoneal bridging. Clinical follow-up is performed one month and one year after surgery. At both occasions, the patient is requested to fill in the Ventral Hernia Pain Questionnaire (VHPQ) and an investigation is done in order to assess the presence of seromas, recurrences or other local complications. One year after surgery, computer tomography is performed. The main purpose of the computer tomography is to quantify the presence of seromas. The study is intended as phase 2 study with the aim of evaluating peritoneal bridging as an alternative to conventional defect closure. If the study shows that bridging does not lead to substantial seroma development, future studies with greater statistical power and other outcome measures will be undertaken.

NCT ID: NCT03305757 Completed - Breast Cancer Clinical Trials

Seroma Reduction After Mastectomy

SAM
Start date: June 1, 2014
Phase: Phase 4
Study type: Interventional

Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction. No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.

NCT ID: NCT03190876 Recruiting - Clinical trials for Complication of Surgical Procedure

Seroma Prevention After Body Contouring Procedures

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.

NCT ID: NCT03167944 Recruiting - Seroma Clinical Trials

Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.

NCT ID: NCT03166384 Completed - Clinical trials for Seroma as Procedural Complication

ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery

ELBCE
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

There was no study about application of electrosurgical bipolar sealing device for mastectomy in Korean population, because Korean national insurance did not cover use of the advanced sealing device until last year. Sample size of the previous studies was too small to draw a solid conclusion. Therefore, this study was designed prospectively to evaluate whether application of bipolar energy device for mastectomy could provide clinical benefit in terms of reducing seroma formation.

NCT ID: NCT02967627 Not yet recruiting - Clinical trials for Surgical Site Infection

VAC Dressings for Colorectal Resections

VACCRR
Start date: November 2016
Phase: N/A
Study type: Interventional

Surgical Site Infections (SSIs) and wound complications are common occurrences following colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has developing evidence for improving wound complication rates in certain populations. However, there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We propose a study in which patients are randomized into one of two treatment arms: 1) incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30 days for diagnosis of infection or wound complication. We will compare primary outcomes in each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction and Number Needed to Treat

NCT ID: NCT02668588 Completed - Seroma Clinical Trials

Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

Start date: October 22, 2015
Phase: Phase 2
Study type: Interventional

This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND). Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.