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Seroma clinical trials

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NCT ID: NCT05391763 Recruiting - Seroma Clinical Trials

Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?

PROFAS
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.

NCT ID: NCT05280353 Recruiting - Clinical trials for Seroma Following Procedure

Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

GALA
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.

NCT ID: NCT05272904 Not yet recruiting - Seroma Clinical Trials

The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery

QUILT
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. Main objective of this randomized stepped wedge study is to assess the impact of large scale implementation of the quilting technique in patients undergoing mastectomy and/or axillary lymph node dissection. This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple and cost-effective technique to increase textbook outcome. Moreover, it is expected that patient comfort is enhanced by quilting.

NCT ID: NCT05178329 Not yet recruiting - Clinical trials for Seroma Complicating A Procedure

Lifting Effect on Recovery After Mastectomy

MUSKELI
Start date: September 2022
Phase: N/A
Study type: Interventional

Breast cancer surgery has evolved towards ever more breast conserving direction. Even thought the surgical regime has become easier for the patient, many instructions given to the patient after the operation base on instructions, which have been used when the performed operations have been more burdensome. Previously the patients have been instructed to lift only light objects after the operation, but according to the current knowledge, this instruction might be unnecessary. The meaning of this study is to compare two patient groups to each other. The other group is instructed to avoid lifting, and the other group is given instructions to lift light weights several times daily. In the study we compare will this have an effect on 1. incidence of upper limb lymphedema 2. seroma formation after surgery 3. quality of patients life after the surgery Inclusion criteria is patients underoing mastectomy but no axillary clearance on day-care basis. Patietns will be randomized in two groups, the other as an intervention group and other as an control group. The patients are asked to fill a questionnaire considering recovery from the operation and possible wound healing problems. The amount of seroma is recorded. The volume of upper limbs is measured before and after the surgery. The study is started in January 2022 and finished in December 2024.

NCT ID: NCT04818580 Terminated - Seroma Clinical Trials

Progressive Tension Sutures in Gender Affirming Mastectomy

Start date: March 25, 2021
Phase: N/A
Study type: Interventional

50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.

NCT ID: NCT04730674 Completed - Clinical trials for Post-mastectomty Seroma

Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

female patients with established diagnosis of post-mastectomy seroma following modified radical mastectomy, were treated by local injection of tetracycline after the seroma fluid was aspirated, then a crepe bandage was applied over the mastectomy area. Then after 5 days the patient were examined again for seroma re-collection or the presence of complications. The amount of seroma aspirated in each session.

NCT ID: NCT04666051 Completed - Seroma Clinical Trials

Fibrin Glue in Inguinal Lymphadenectomy

Start date: May 2015
Phase: N/A
Study type: Interventional

Seroma is one of the most common encountered morbidities after inguinal lymph node dissection (ILND). It can cause not only much nuisance to both patients and doctors but also its presence can lead to many complications. This study aimed at evaluation of the role and effect of using fibrin glue on seroma reduction in patients undergoing ILND. Thirty-two patient have undergone ILND for various causes. The patients were randomized into two groups; 16 ILND in each. In one group, fibrin glue sealant was applied with a dose of 2ml per 100 cm2 surface area then drain placement was performed. Whereas, in the control group, only drain placement was used. Preoperative, operative and postoperative data were recorded and analyzed.

NCT ID: NCT04554407 Active, not recruiting - Clinical trials for Hematoma Postoperative

Study to Evaluate the Performance of a Sustained Vacuum System

Start date: August 11, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.

NCT ID: NCT04496180 Not yet recruiting - Clinical trials for Surgical Site Infection

Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

CiPNT/SSI
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Post-operative wound complications in abdominal surgery have a major impact on patient outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not clear in the literature moreover concerning its potential economic benefits The hypothesis of this study is that CINPt has the potential to reduce Surgical Site Infections. Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.

NCT ID: NCT04471142 Not yet recruiting - Seroma Clinical Trials

Effectiveness of Compressive Bandage Use in Seroma Prevention

Start date: November 8, 2021
Phase: N/A
Study type: Interventional

INTRODUCTION: Seroma is the most common complication after surgical treatment for breast cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The therapeutic bandage has been inserted in clinical practice because it is similar to the elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain and local swelling, and may have benefits for prevention and treatment of seroma when applied compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and control groups by lot (270 envelopes, 135 patients per group). The intervention group, in addition to the use of the drain, will be submitted to the compression bandage on the day of hospital discharge and will be reevaluated on the seventh day. The control group will follow the institutional routine, using only the drain. The incidence and volume of the seroma, as well as the length of stay of the drain will be evaluated after 30 days through the medical record. Symptoms and skin changes resulting from the use of the bandage will be evaluated through a specific form. ANALYSIS: Descriptive analysis will be by measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds ratio (for categorical variables) and by mean difference (Student's t-test), considering a 95% confidence interval. To control the confounding variables, multiple logistic regression (categorical outcome) and multiple linear regression (continuous outcome) will be performed by the Stepwise Forward method, including variables with p <0.20.