39 Clinical Trials for Various Conditions
Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with Early Recovery After Surgery (ERAS) protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE).
The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Neck morbidity after radiation therapy and surgery includes difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. In addition, the researchers will find out whether the study procedure is effective at reducing neck morbidity and improving quality of life after cancer treatment. The researchers will measure quality of life by having participants answer questionnaires.
Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.
Despite many recent advances in pain management, post-operative pain is widely considered to be poorly managed. Furthermore, the mainstay of current pain management is opioids, for which there is strong evidence of ill effects and long-term potential for addiction. There are many studies demonstrating that perineural regional anesthesia can be superior to intravenous opioid analgesia, and that the technique is safe. By using temporary implanted catheters, this method can now deliver prolonged analgesia, thus reducing the need for opioids in the postoperative period. Regional anesthesia is a proven technique and used daily by anesthesiologists, and it is also the first choice for hip and knee replacement surgery for orthopedic surgeons. Patients undergoing head and neck reconstruction with the use of free tissue transfer experience a significant amount of post-operative pain due to the complexity of the surgery, the presence of a head and neck surgical site as well as a secondary donor site, and existing co-morbidities, most commonly malignancy, that also cause significant pain. These patients often require opioids for pain control throughout the hospital stay, and are almost always discharged home with additional opioids. By utilizing regional anesthesia blocks at the donor sites, the investigators can potentially reduce post-operative pain while also reducing the use of opioids.
The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema. The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.
The aim of this randomized, double-blind controlled trial is to determine the efficacy of transdermal fentanyl for the management of early postoperative pain in women undergoing mastectomy followed by immediate TRAM or DIEP flap reconstruction. We will examine whether the use of the fentanyl patch as a bridge between epidural and oral analgesia will improve overall pain relief compared to placebo patch. We further propose to study whether the fentanyl patch is associated with improved ability to sleep, patient satisfaction, and functional capacity at one week, and whether it is associated with different side effects than standard therapy without the patch. Following informed consent, patients will undergo mastectomy and reconstruction, and receive epidural fentanyl for initial postoperative analgesia. Patients will be randomized to active (25 mcg/hr Duragesic) or placebo patches on postoperative day three, and the epidural will be weaned over the next 12 hours. Pain intensity scores and relief from pain will be assessed every day while in the hospital and oral and IV opioid use recorded. Patients will be discharged to home with a supply of 2 patches and oral medication, and will be asked to fill out a daily pain and medication log.
The main purpose of this study is to determine which type of medication, sufentanil or methadone, is better at controlling pain during and, more importantly, after surgery in patients undergoing a head and neck dissection with free flap or rotational tissue reconstruction. Prior to their operation, subjects will be randomized to receive either Sufentanil or Methadone. After surgery, research staff will obtain information about recovery and pain levels.
The purpose of this study is to determine whether a program to optimize patient physical fitness and nutrition ("prehabilitation") prior to and after plastic surgery involving the abdomen improves surgical outcomes. The investigators hope to determine how a multimodal peri-operative prehabilitation program can be most effective in engaging and motivating patients to physically and mentally get ready for an abdominally-based plastic surgery operation. The overall goal is to determine if this program will improve post-operative recovery after abdominally-based plastic surgery. The importance of this new knowledge is better understanding of ways that plastic surgeons can improve outcomes, engagement, and experience of patients undergoing abdominally-based plastic surgery operations. This would translate to increased healthcare value and better long-term outcomes.
The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.
The purpose of this study is to determine if a new non-invasive imaging technology, called Photoacoustic Computed Tomography (PACT), can be used in the pre-operative setting to better visualize the blood supply of reconstructive flaps used in Plastic Surgery.
Patients undergoing free flap reconstructive surgery at University of California, Davis Medical Center (UCDMC) will be assigned randomly into no intervention group (immediate post operative care in an ICU) or intervention group (immediate post operative care in a non-ICU specialty ward). The investigators hypothesize that there is no significant difference in the length of stay (LOS) or complication rate between head and neck free flaps patients managed immediately post-operatively in an ICU versus a non-ICU specialty ward. The primary objective is to compare the postoperative LOS between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward. The secondary objective is to compare differences in the rate of complications between head and neck free flap patients managed initially in an ICU versus a non-ICU specialty ward. Finally, the tertiary objective is to compare differences in resource utilization between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward.
The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction. This is a randomized clinical trial. Approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. Patients will be asked to complete a few questionnaires including a VAS scale, the Surgical Outcomes scale, the NOSE instrument, and the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ). This study was a pilot study designed to determine the feasibility of these procedures.
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.
This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).
Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.
This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.
The objective of this pilot study is to examine the efficacy of the ON\~Q Pain Relief System plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery. The primary outcome measure will be postoperative opioid analgesia requirements. Other outcomes will also be assessed, including pain scores, quality of recovery, and resource utilization.
The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.
This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. Free flaps are units of tissue transferred from one area of the body to another with an intact blood supply. pPCA uses magnetic resonance imaging (MRI) to create images of blood vessels inside the body. Using pPCA may help doctors develop better surgical plans for patients with breast cancer undergoing post-mastectomy reconstruction surgery with free flap methods.
The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.
The purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.
Patients will complete a survey before and after watching the WashU DIEP Flap Video at their pre-operative standard of care visit, and a third survey at their post-operative standard of care visit. These surveys will use questions from SILS, APAIS, PEMAT, and AIM/IAM to assess the patient's health literacy, demographics questions, and questions concerning patient understanding and anxiety surrounding the procedure. The purpose of the post-op survey will be to assess how well the video set expectations of the procedure and recovery process and will repeat questions asked pre-operatively. Survey responses will be analyzed to determine if there are beneficial trends and improvement in patient understanding and anxiety due to adjunct video usage. Primary Objective: The primary aim of the study is to determine if our animated video affects understanding and anxiety survey scores in patients undergoing DIEP breast reconstruction.
Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after reconstructive surgery. This desire has led the surgical community to investigate operative techniques for achieving this goal. However, few studies have examined the effectiveness of breast sensory restoration. Sensory nerves are nerves responsible for sensation from skin. When a sensory nerve is cut, sensation is lost to the area supplied by the nerve. In the case of Breast reconstruction this involves the nerves supplying the skin overlying breast(s). 'Neurotization' refers to regeneration of the nerve after it has been cut. This means that the cut nerve is being repaired in order to restore its function. In Neurotization this repair is carried out using a new "source". In this case, the investigators want to restore function of the nerves that supply the skin overlying the breast(s). The investigators will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new "source") that is being transferred and attaching it to a nerve in the chest wall. The Avance® Nerve graft is a nerve graft material that has been produced by Axogen, Inc. The graft is made by processing donated human nerves. This graft is used during neurotization to bridge the gap and join the nerve from the abdominal tissue to the nerve in the chest wall. The use of the graft helps the body to attach these 2 nerves and improves nerve repair. When neurotization is done without the nerve graft there is a possibility that the surgeon may require extra nerve material to join the 2 nerves. Traditionally, in this case the surgeon would have to obtain a separate donor nerve from another part of the patient's body. This technique carries the risk of complications to part of the body that the separate donor nerve was obtained from - loss of sensation, infection or neuroma formation (an abnormal growth of nerve tissue that can cause pain, burning or tingling sensation, numbness). The Avance nerve graft avoids the need for the additional donor nerve and the possible complications associated with it. The Avance® Nerve Graft is currently being used in some women during breast reconstruction surgery, however the effectiveness of this procedure in improving the restoration of sensation has not been proven. Women undergoing reconstruction of one breast and at the same time using the women's own tissue as part of standard clinical care, may join.
Women that require breast reconstruction and meet eligibility will be enrolled in this study. The study is being completed to determine the effect of caffeine in deep inferior epigastric perforator (DIEP) flap perfusion using the Vioptix tissue oximeter monitor and to determine if caffeine in the acute postoperative period affects overall flap complication or loss (complete loss from anastomotic issue). The researchers hypothesize that a single 8 ounce cup of regular coffee will not affect free flap perfusion as indicated by the Vioptix, and that it will not affect overall free flap survival at thirty days.
Mohs micrographic surgery (MMS) followed by skin reconstruction has been widely accepted for treatment of many skin cancers. To further characterize the trends in MMS and reconstruction for skin cancer, a retrospective analysis will be performed using the Optum© Clinformatics® DataMart de-identified commercial claims database from 2001-2016. The findings may provide critical data for future prospective studies in skin cancer treatments.
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.
This is a randomized study using a variety of techniques to compare and examine blood flow to the remaining skin after mastectomy. All treatments being used are considered standard of care and are not experimental. The objective is to compare the techniques and the incidence of perfusion related problems in patient's undergoing mastectomy with immediate breast reconstruction.
The purpose of this study is to determine if the integrated imaging goggle (Smart Goggles) is as good as or better than current technology used to assess tissue perfusion (the extent of blood flow to the tissue) in certain types of breast reconstruction procedures. The participants will be asked to participate in the study if they are scheduled to have a breast reconstruction procedure using a technique that involves transferring abdominal skin and tissues to the affected side of the chest. This technique is known as a breast reconstruction with a Deep Inferior Epigastric Artery Perforator (DIEP) flap. In this pilot study, the investigators are testing the feasibility of a new device, the Integrated Imaging Goggle system (also called "Smart Goggles") as a surgical aid to differentiate between tissue with adequate blood flow and tissue without adequate blood flow by comparing measurements of fluorescence in blood vessels with current technology, the SPY-Elite system. In this study, researchers will test how quickly and accurately the fluorescent dye used to identify adequate blood flow is detected by Smart Goggles compared to the SPY Elite system.
Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and neck reconstruction after head and neck cancer removal. The procedure involves removing some muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of this study is to determine the impact of ALT on ambulation and activities of daily living (ADLs)