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Abdominoplasty clinical trials

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NCT ID: NCT04207047 Active, not recruiting - Abdominoplasty Clinical Trials

Histologic Evaluation of Tissue Following Lutronic System Exposure

Start date: October 2, 2018
Phase: N/A
Study type: Interventional

Enrollment of up to 25 subjects; subjects enrolled may be greater than subjects receiving test spot exposure visits. No pre-treatment medication prior to test spot exposure. Up to 6 tattoo points will be applied to each side of the abdomen immediately before or after test spot exposures to map and locate exposed spots on the excised pannis. Tattoos in the area to be resected will be placed to outline the test spot exposure areas. Photographs of exposed sites may be taken at investigator's discretion.

NCT ID: NCT04182880 Completed - Abdominoplasty Clinical Trials

Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain

Start date: January 6, 2020
Phase: Phase 2
Study type: Interventional

Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty

NCT ID: NCT04085822 Completed - Abdominoplasty Clinical Trials

Histology of SMA-001 in the Abdomen

Start date: August 29, 2019
Phase: N/A
Study type: Interventional

Silk Medical Aesthetics' Inc. device, SMA-001, is currently under development as a dermal filler to fill wrinkles and folds. This study is designed to collect short-term visual, photographic, and histological and safety data on small aliquots of the product as part of device development. It is an open label study involving up to three investigational sites and a maximum enrollment of 10 subjects. Juvéderm Ultra Plus XC, an FDA-approved dermal filler will serve as a control device. Briefly, the investigational product and the control device will be injected into the abdomen of patients intending to undergo abdominoplasty at a later date. The patients will be followed for 30 days post injection through visual observation. At 30 days post injection, the injected gel and associated tissue will be removed via biopsy during the abdominoplasty surgery and histology slides created for analysis.

NCT ID: NCT03940885 Recruiting - Abdominoplasty Clinical Trials

Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Abdominoplasty is one of the most popular body-contouring procedures. Patients that undergo body-contouring abdominoplasty usually have important analgesic requirements. Given the substantial incision and soft-tissue undermining associated with this procedure, postoperative pain is a concern for patients and surgeons. Previous studies have typically incorporated multiple nerve blocks to improve analgesia after abdominoplasty. Different anesthetic techniques have been developed to overcome this problem such as Epidural anesthesia, Transversus abdominis plane block either open technique or ultrasound-guided, Paravertebral block and Erector Spinea plane block. Improving postoperative pain control in this kind of surgery leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. The ultrasound-guided erector spinae plane (ESP) block is a recent block described for various surgeries for postoperative analgesia. It is reported that it have an analgesic effect on somatic and visceral pain by affecting the ventral rami and rami communicantes that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia. The transversus abdominis plane (TAP) block is a technique of locoregional anesthesia that blocks the sensorial afferent nerves localized between the transversus abdominis muscle and the internal oblique muscle. In this study, the analgesic efficacy and duration of ultrasound (US) guided Erector spinea plane block and Transversus abdominis plane block when Lidocaine HCL is added as an adjuvant to bupivacaine will be compared.

NCT ID: NCT03770195 Withdrawn - Abdominoplasty Clinical Trials

Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

Start date: November 13, 2018
Phase:
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 Completed - 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 Botulinum Neurotoxin Serotype E (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 Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants 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 - 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: 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.