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Hematoma Postoperative clinical trials

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NCT ID: NCT05441592 Recruiting - Clinical trials for Hematoma Postoperative

A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

Start date: August 15, 2022
Phase: Phase 4
Study type: Interventional

This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.

NCT ID: NCT04947514 Completed - Clinical trials for Venous Thromboembolism

Use of Tranexamic Acid in Reduction Mammoplasty

TREX-ARM
Start date: October 29, 2021
Phase: Phase 4
Study type: Interventional

Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion, wound healing issues, and unfavorable surgical outcomes. Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. However, despite its consistently reported efficacy, low cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery. The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction mammoplasty. The investigators hope to contribute to the growing body of literature supporting tranexamic acid to reduce unwanted surgical bleeding.

NCT ID: NCT04918589 Not yet recruiting - Breast Cancer Clinical Trials

Tranexamic Acid for Alloplastic Breast Reconstruction

Start date: August 2022
Phase: Phase 3
Study type: Interventional

Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events. In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

NCT ID: NCT04918576 Not yet recruiting - Tranexamic Acid Clinical Trials

Topical Tranexamic Acid for Bilateral Breast Reduction Surgery

Start date: August 2022
Phase: Phase 3
Study type: Interventional

Hematoma is a common complication of bilateral breast reduction (BBR) surgery. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events. In this randomized control trial (RCT) evaluation TXA use in BBR, for which one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in BBR reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

NCT ID: NCT04559646 Completed - Clinical trials for Hematoma Postoperative

Application of the "Haemoblock" in Pacemaker Patients

Start date: January 1, 2021
Phase:
Study type: Observational

Pocket hematoma is a known complication of pacemaker (PM) implantation. Pocket hematoma is accompanied by a local discomfort associated with the infiltration of subcutaneous tissue. In some cases, this complication requires repeated surgical revisions, which increases the risk of infection, and increases the duration of a hospital stay. The search for ways to prevent bleeding from the PM pocket is of great practical interest. This question is especially acute in relation to patients who are constantly on anticoagulation and/or antiplatelet therapy. A number of authors propose to carry out complete or partial cancellation of these drugs for the period before surgery and in the early postoperative period. In our opinion, this approach in most cases carries a potential risk to the health of patients, especially in the case of patients who have previously undergone surgical correction of valve insufficiency and/or who have undergone percutaneous endovascular interventions. The use of local hemostatic drugs is one of the promising directions for increasing the efficiency of intraoperative hemostasis. The haemostatic solution "Haemoblock" has shown its hemostatic potential in general surgical practice. The possibilities of "Haemoblock" in the prevention of pocket hematoma have not been studied. The hemostatic effect of "Haemoblock" is achieved within 1-2 minutes due to the formation of a clot with blood plasma proteins, first of all with albumin. As a result of the action of the "Haemoblock", a strong polymethacrylate membrane is formed on the surface of the wound, which, among other things, has a bactericidal effect.

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: NCT04389398 Not yet recruiting - Clinical trials for Hematoma Postoperative

Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices

Start date: May 25, 2020
Phase: N/A
Study type: Interventional

As the number of implanted cardiovascular implanted electronic devices (CIEDs) increases, the incidence of their complications also grows. Pocket hematoma is an important complication of CIED implantation, which has been reported in 2.9-9.5% of CIEDs patients. Pocket hematoma can cause significant pain and interfere with proper wound healing, and it also increased the risk of infection and may prolong length of stay. Pocket compression is usually applied to compress bleeding vessels and reduce bleeding after implantation. A conventional compression method is to place a sandbag over the pocket, and then using adhesive tape to fix the sandbag. Due to adhesive tape is elastic and the tape may be pulled by patients' activity, sandbag easily migrated from the site. Therefore, nurse must readjust the position of sandbag, or even remove the adhesive tape and perform re-compress. Furthermore, adhesive tape can cause skin erosion. All of which not only result in patients' discomfort and dissatisfaction, but also increase the burden on nurses and wastes resources. We designed a pocket compression fixation belt. We assumed that using this fixation belt can ensure the compression effect while avoiding sand bag displacement, reducing skin erosion and decrease the workload of care.

NCT ID: NCT03738527 Recruiting - Breast Cancer Clinical Trials

SEroma Reduction pOst MAstectomy "SEROMA Study"

SEROMA
Start date: October 7, 2019
Phase: Phase 4
Study type: Interventional

This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. In other words, the investigators want to determine if applying TXA inside the surgical wound before it is closed helps reduce blood or serous fluid accumulation at the operative site. Dependent on the results of this study, a further larger trial may or may not take place. Post-operative seromas and hematomas are common complications of mastectomy surgery not only leading to infection, discomfort, wound dehiscence or emergency room visits; they also delay in some instances post-operative adjuvant radiotherapy. Establishing whether or not topical TXA is an effective strategy to decrease those complications can potentially impact positively the breast cancer treatment. To achieve this aim, this randomized pilot study will first determine whether a larger multicenter study if feasible. This study will replicate a formal randomized trial at a smaller scale in a single center in order to assess the recruitment and randomization process, as well as provide preliminary results for our research question.

NCT ID: NCT03535116 Recruiting - Clinical trials for Hematoma Postoperative

The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery

Start date: January 1, 2020
Phase: Phase 4
Study type: Interventional

It has been a longstanding teaching in plastic surgery that intra-operative ketorolac use for postoperative pain control increases hematoma and bleeding in breast reduction surgery. However, there is no literature that supports this teaching. Ketorolac is used routinely in free flap reconstruction including breast reconstruction as well as many other surgeries including hand surgery without increased risks of hematoma or bleeding. Ketorolac has been shown to give good postoperative pain control. The object of this study is to look at whether ketorolac increases the rate of hematoma/bleeding in breast reduction. If there is no increased risk of hematoma, then ketorolac can be used safely for postoperative pain control with an increased risk of hematoma/bleeding. Normally, without using ketorolac, the hematoma rates in a breast reduction are 1-2%.