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Abdominoplasty clinical trials

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NCT ID: NCT03770195 Withdrawn - Abdominoplasty Clinical Trials

Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

Start date: November 13, 2018
Study type: Observational [Patient Registry]

The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.

NCT ID: NCT03467724 Recruiting - Breast Augmentation Clinical Trials

Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift

Start date: January 23, 2018
Phase: N/A
Study type: Interventional

Split-body/face evaluator-blind study of the safety and performance of fractional RF for the treatment of surgical scars following breast augmentation, abdominoplasty or face lift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following face lift surgery. Subjects will receive a total of three treatments of their surgical scars at one-month intervals on one side of the body or face only. Subjects will be followed up at one, two, three and ten months after their last treatment. Outcomes will be compared to the non-treated side.

NCT ID: NCT03429556 Terminated - Abdominoplasty Clinical Trials

Study to Evaluate EB-001 in Reducing Musculoskeletal Pain in Abdominoplasty

Start date: May 8, 2018
Phase: Phase 2
Study type: Interventional

To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Rectus Abdominus (RA) in subjects undergoing abdominoplasty.

NCT ID: NCT03246971 Completed - Acute Pain Clinical Trials

Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Start date: August 24, 2017
Phase: Phase 2
Study type: Interventional

This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.

NCT ID: NCT03190876 Recruiting - Seroma Clinical Trials

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: NCT03143959 Completed - Clinical trials for Urinary Incontinence

Functional Improvement With Abdominoplasty

Start date: September 1, 2014
Phase: N/A
Study type: Observational

The study investigates the impact of abdominoplasty in the post partum population on the symptoms of back pain and urinary incontinence. Patients presenting for abdominoplasty fill out validated questionnaires for both back pain (Oswestry Disability Index) and urinary incontinence (ICIQ-UI short form). They complete the same questionnaires 6 weeks and 6 months post op. The prospectively gathered data gives an insight into the incidence of functional symptoms in this post partum group preop as well as the degree of improvement gained postop. This is a multicenter trial with 9 surgeons submitting patients to the study, which ran for 19 months.

NCT ID: NCT02949778 Completed - Pain, Postoperative Clinical Trials

Quadratus Lumborum Block for Abdominoplasty

Start date: November 7, 2016
Phase: Phase 4
Study type: Interventional

Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. The aim of study is to investigate the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.

NCT ID: NCT02930447 Not yet recruiting - Abdominoplasty Clinical Trials

Evaluation of the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty

Start date: January 2018
Phase: N/A
Study type: Interventional

Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in plastic surgery. However, only pilot studies and retrospective uncontrolled trials have reported the potential benefits of autologous glue treatment up to now. Therefore, a larger, blinded, randomized and placebo-controlled clinical trial would be useful to determine whether platelet-rich plasma is safe and effective in abdominoplasty procedures. Currently, there are pharmacological options such as artificial fibrin glues composed of homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a risk of transmissible diseases and may induce allergic reactions. Therefore, autologous glues, which are fully made of blood components from the patient itself (autologous fibrinogen contained in PRP and autologous thrombin) represents a safe alternative to artificial biological glues. Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an autologous activated thrombin serum, on the other hand, in a safe and rapid manner. RegenKit®-Surgery is a CE-marked class IIb medical device. This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared with RegenKit®-Surgery when used in reconstructive abdominoplasty.

NCT ID: NCT02302222 Terminated - Abdominoplasty Clinical Trials

The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing

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

The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as compared to SOC dressing, and to significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC surgical incision dressing.

NCT ID: NCT02140385 Withdrawn - Abdominoplasty Clinical Trials

Role of Preservation of Scarpa's Fascia in Abdominoplasty

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether leaving a thicker layer -which preserves the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases the damage to the lymphatic system. In order to investigate the effect of leaving a thinner or slightly thicker layer intact during a tummy tuck, patients who are already planning to undergo the surgery, and who agree to participate, will be randomly assigned to two groups in a manner similar to flipping a coin. The first group will have their abdominoplasty performed with a thinner layer of abdominal wall left in place while the second group will have the surgery with a slightly thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of care, and the aesthetic outcomes will not be negatively impacted by either of the options. Before and after the surgery, a procedure called lymphoscintigraphy will be performed. Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is injected and then detected by a special camera. The pictures provided by the lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will help investigators to know what method of performing the tummy tuck leaves the lymphatic system most intact. In addition, photographs of each patient's abdomen will be taken using a special camera that allows investigators to put the photographs in the computer and compile a 3-dimensional image. Investigators will be able to look at the volume changes from swelling after the surgery using these pictures. Finally, an ultrasound will be used to help identify any seromas, or fluid collections, that may form after the surgery. The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid draining lymphatic system and whether or not that effects recovery after the procedure.