Clinical trials: Breast Reconstruction
Breast Reconstruction
Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction
The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and…
- Trial name
- HARMONIC001 (NCT00778947)
- Testing
- Harmonic Synergy Dissecting Hook (Harmonic Scalpel), Electrocautery Diathermy
- Where
- United Kingdom
- Sponsor
- St Andrew's Centre for Plastic Surgery
Breast Cancer
PECI/SPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
Regional Anesthesia is a procedure in which numbing medication is injected around nerves that transmit pain from areas involved in a surgery. The objective is to block the nerves so a patient does not feel pain after surgery.
- Trial name
- NCT02821676
- Volunteers
- 42 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Reconstruction
Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Mentor is undertaking a five-year prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses.
- Trial name
- Adjunct (NCT00948948)
- Testing
- Silicone Gel-Filled Mammary Prostheses
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC
Mastectomy, Postoperative Pain
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques.
- Conditions
- Mastectomy, Postoperative Pain, Complications
- Trial name
- NCT00616824
- Testing
- Dermamatrix to cover lateral aspect of tissue expander, Serratus anterior to cover lateral aspect of tissue expander
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Vanderbilt University Medical Center
Breast Cancer
Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction.
- Trial name
- NCT01679223
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Nevada, Las Vegas
Postoperative Pain Management, Analgesia, Postoperative
Superficial vs Deep Serratus Anterior Plane Block for Analgesia After Mammoplasty
The serratus anterior plane block (SAPB) is an ultrasound-guided fascial plane block used for perioperative analgesia in thoracic and breast surgeries.
- Conditions
- Postoperative Pain Management, Analgesia, Postoperative, Breast Surgery, Mammoplasty Patient
- Trial name
- DSAPvsSSAP (NCT07502846)
- Testing
- Superficial Serratus Anterior Plane Block, Deep Serratus Anterior Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 58 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
Breast Cancer
Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR
Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery…
- Trial name
- DRAIN (NCT07237828)
- Testing
- Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
- Where
- China
- Volunteers
- 379 people
- Sponsor
- Du Zhenggui
Breast Cancer
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
- Trial name
- NCT02061527
- Testing
- Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant
- Where
- 5 sites in Sweden, United Kingdom
- Volunteers
- 135 people
- Sponsor
- Karolinska University Hospital
Breast Neoplasms
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.
- Trial name
- NCT06024187
- Testing
- Cold dissection, Electrocautery Dissection
- Where
- China
- Volunteers
- 566 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Post-mastectomy Breast Reconstruction
Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
- Trial name
- NCT04477538
- Testing
- Post-mastectomy breast reconstruction physical well-being survey
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Washington University School of Medicine
Breast Cancer, Surgery
LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December…
- Trial name
- LIMBO (NCT06101732)
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Bacterial Infection, Anti-infective Agents
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures.
- Conditions
- Bacterial Infection, Anti-infective Agents, Breast Implantation
- Trial name
- NCT01244698
- Testing
- Cefadroxil discontinued early, Cefadroxil until drain removal
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Stony Brook University
Pain, Postoperative, Breast Cancer
Speeding Recovery From Pain and Opioid Use
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living.
- Conditions
- Pain, Postoperative, Breast Cancer, Opioid Use, Surgery
- Trial name
- NCT03388814
- Testing
- Local infiltration of bupivacaine, Pectoralis Nerve block
- Sponsor
- Wake Forest University Health Sciences
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC).
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Trial name
- NCT06153836
- Testing
- Neurotization Procedure, Questionnaire Administration, Subcutaneous Mastectomy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Mayo Clinic
Malignant Neoplasm of the Breast
Emotional Evaluation and Reconstructed Breast Satisfaction
Data from the National Cancer Institute (Inca) reveal that breast cancer is the most common type of cancer among women worldwide. In Brazil, it is second only to non-melanoma skin cancer.
- Trial name
- NCT03777852
- Testing
- First Questionnaire application, Second Questionnaire application
- Where
- Brazil
- Volunteers
- 110 people
- Sponsor
- University of Sao Paulo
Breast Cancer, Necrosis
Novel Application of Indocyanine Green as a Biomarker to Identify Tissue Necrosis in Mastectomy Patients
Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who undergo mastectomy, with over 100,000 procedures performed in the U.S. in 2018.
- Trial name
- NCT04145323
- Testing
- ICG microangiography
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Psychological
Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer
The aim of the present study is to verify the effects of a psychological-clinical intervention supported by the technique of expressive writing, on the post-operative course in terms of mental and physical health in patients…
- Trial name
- BrEva (NCT05616988)
- Testing
- psychological-clinical intervention with three days of expressive writing by Pennebaker
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- University of Roma La Sapienza
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Carcinoma
PARTial BREast RECONstruction With Chest Wall Perforator Flap
The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Carcinoma, Breast Neoplasms, Breast Surgery
- Trial name
- PartBreCon (NCT06728527)
- Where
- United Kingdom
- Volunteers
- 1,001 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Breast Reconstruction
Negative Pressure in PAP Donor Sites
A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021.
- Trial name
- NCT05491473
- Testing
- Closed incisional negative pressure wound therapy (iNPWT) system
- Where
- Taiwan
- Volunteers
- 25 people
- Sponsor
- Chang Gung Memorial Hospital
Breast Cancer, Unilateral
MIAMI Safe Surgery for Multiple Breast Cancers
Sometimes women have more than one breast cancer in the same breast at the same time. These women are usually offered a mastectomy (removal of that breast) and breast reconstruction.
- Trial name
- MIAMI (NCT03514654)
- Testing
- Mastectomy, Therapeutic Mammoplasty
- Where
- 7 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- University College, London