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Mammaplasty clinical trials

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NCT ID: NCT03069885 Enrolling by invitation - Clinical trials for Breast Neoplasm Female

iNPWT in Immediate Breast Reconstruction

Start date: November 20, 2017
Phase: N/A
Study type: Interventional

Due to the Danish breast cancer-screening programme and the increased use of genetic counselling, Danish women are being diagnosed with breast cancer, or a high lifetime risk of developing breast cancer, at a younger age than previously. An increasing proportion of these women pursue an immediate breast reconstruction, where the breast is removed and reconstructed in a single surgical procedure. As some of these women will need to undergo adjuvant cancer therapy after their breast surgery, fast recovery is essential in order for the adjuvant therapy not to be delayed. With the development of new surgical techniques, the complication rate to the immediate breast reconstructions has improved. However, wound-healing issues remain one of the most common complications to the surgery with the possibility of delaying the adjuvant therapy and diminish the aesthetic result. Incisional negative pressure wound therapy (iNPWT), is a new approach for surgical site closure. Recently, iNPWT has shown promising results in lowering post-operative complications, including wound-healing issues, in other surgical settings. However, iNPWT has still not been studied in an immediate breast reconstructive setting. The current randomized controlled clinical study will investigate if an iNPWT system, is able to provide women seeking an immediate breast reconstruction with faster healing and superior aesthetic results compared to the conventional post-operative wound dressings used today. The investigators plan to include 60 women, randomized in a 1:1 ratio between iNPWT or conventional wound dressing. The primary outcome measure is the time until removal of the surgical drains, which corresponds to the healing progression. Secondarily, complications to the surgery, assessment of the scar (measured using the Patient and Observer Scar Assessment Scale) and patient reported satisfaction with the reconstruction (assessed using the BREAST-Q questionnaire) will be performed. Included patients are examined pre-operatively, and at the routine controls at four weeks and four months post operatively. The results from the current study will elucidate if iNPWT aids wound healing after immediate breast reconstruction, which would lead to fewer patients experiencing delays before their adjuvant therapy. Furthermore, the results from the aesthetic satisfaction will elucidate if iNPWT provides the patients with a better self-reported aesthetic result.

NCT ID: NCT03016663 Completed - Mammaplasty Clinical Trials

Volumetric Study of Fat Resorption After Breast Lipofilling

Lipofilling
Start date: September 2015
Phase: N/A
Study type: Observational

Prospective observational study to evaluate effects on washing to improve viability of fat grafts in breast lipofilling.

NCT ID: NCT02791672 Not yet recruiting - Mammaplasty Clinical Trials

Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting

Start date: June 2016
Phase: N/A
Study type: Observational

The pedicled latissimus dorsi flap is a piece of tissue taken from the back that is used to reconstruct the breast after cancerous tissue is removed. Over the years, improvements in surgical technique and pain control have decreased the length of stay in hospital after this procedure. Recently, early discharge after breast reconstruction using another very similar pedicled flap, called the transverse rectus abdominis flap, was shown to be safe, patient-centered, and associated with significant hospital cost-savings by another Canadian group. With increasing pressure from hospital administrators to weigh financial considerations into treatment decision making, doctors must test cost-saving strategies in order to ensure patient satisfaction and safety. Here, we plan to evaluate patient safety, satisfaction and cost efficacy in breast reconstruction using the pedicled latissimus dorsi myocutaneous flap. We hypothesize that patient care planning can allow for safe and cost-effective same-day discharge and improved patient satisfaction after autologous breast reconstruction using the pedicled latissimus dorsi flap. After nearly 10 successful same-day discharges using this flap, our experience at the Ottawa Hospital suggests that this practice is safe, has increased patient satisfaction scores, decreased narcotic use, no short or long term complications and is more cost effective compared to patients who stay overnight. In the present study, we hope to quantify our results by demonstrating that same day discharge is a cost effective strategy that does not compromise patient safety and satisfaction.

NCT ID: NCT02662036 Terminated - Mammaplasty Clinical Trials

Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

Start date: February 29, 2016
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.

NCT ID: NCT00616135 Completed - Breast Neoplasms Clinical Trials

Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy

RESTORE-2
Start date: June 2008
Phase: Phase 4
Study type: Interventional

A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).

NCT ID: NCT00514748 Completed - Mammaplasty Clinical Trials

A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction

Start date: January 2007
Phase: N/A
Study type: Interventional

Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one vessel pedicle and observe its survival in breast reconstruction.

NCT ID: NCT00466765 Completed - Mastectomy Clinical Trials

Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting

Start date: January 2010
Phase: N/A
Study type: Interventional

The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro grafting breast augmentation and reconstruction procedures.

NCT ID: NCT00436449 Completed - Cicatrix Clinical Trials

RN1001(Avotermin) in Scar Improvement Following Breast Augmentation

Start date: December 2004
Phase: Phase 2
Study type: Interventional

This will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery. Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl of placebo solution per linear centimetre intradermally into both margins of their other breast wound. The allocation of treatment to wound (left or right) will be randomised and double blind.

NCT ID: NCT00432328 Terminated - Cicatrix Clinical Trials

Juvista (Avotermin) in Breast Reduction Surgery Scars

Start date: October 2006
Phase: Phase 2
Study type: Interventional

Severe scarring is a common problem following breast reduction surgery, studies have shown that over 64% of patients develop a hypertrophic scar at three months after the operation. Scar severity can be influenced by a large number of factors including age, sex, skin thickness and tension, ethnicity and the position of the scar on the body. Therefore the most sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to compare bilateral wounds on the same individual. Bilateral breast reduction surgery provides an ideal model for a within patient evaluation of anti-scarring activity in wounds which develop into bad scars. This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance applied to approximated wound margins following bilateral reduction mammaplasty.

NCT ID: NCT00310882 Withdrawn - Breast Neoplasms Clinical Trials

Involvement of Endogenous Digitalis-like Compounds in Breast Cancer

Start date: May 2006
Phase: N/A
Study type: Observational

The endogenous digitalis-like compounds (DLC)are steroid hormones synthesized and released from the adrenal gland.They are integrated in the feed-back system of the Hypothalami-Pituitary-Adrenal gland axis.One of their remarkable function is to induce apoptosis in malignant cells. Recently, accumulating data point to the possibility of using synthetic DLC as new anti-cancer drugs. Less is known about the endogenous metabolism of these compounds in cancer patients. Proceeding from preliminary clinical data which demonstrated significantly reduced DLC plasma levels in breast cancer patients and from in vitro data which showed an impaired release of DLC towards stress stimuli in athymic nude mice,we put up the hypothesis that a latent adrenal insufficiency with low DLC levels facilitates the induction and progression of tumor diseases.