Clinical trials: Reconstruction Breast Surgery
Surgical Wound Infection
Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
Surgical Site Infections (SSI) represents a significant complication in plastic surgery. Infections can result in a prolonged recovery and impair long-term cosmetic appearance.
- Trial name
- NCT02779296
- Testing
- 2-Octyl Cyanoacrylate Glue
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Breast Cancer, Ductal Carcinoma in Situ
The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.
The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia…
- Trial name
- NCT04248179
- Testing
- Ropivacaine injection, Saline 0.9%, Sufentanil and PONV prophylaxis
- Where
- Denmark
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Zealand University Hospital
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
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate…
- Trial name
- NCT03383198
- Testing
- Liposomal bupivacaine right injection, Liposomal bupivacaine left injection
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Prisma Health-Upstate
Perfusion; Complications
Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
- Trial name
- Presygen™ (NCT03715270)
- Testing
- Image surgical area
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Christie Medical Holdings, Inc.
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Opioid Use, Pain, Postoperative
Pain in Breast Surgery Intervention
This study will be a randomized control trial providing an educational component to study participants and a pre-operative and post-operative survey with a goal to show an improvement in pain control, decrease in narcotic use…
- Trial name
- NCT04058938
- Testing
- Educational handout instrument, Control
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Breast Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Breast Reconstruction Surgery
Distance Healing in Wound Healing
This trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery.
- Trial name
- NCT00067717
- Testing
- Distance healing
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- California Pacific Medical Center Research Institute
Bariatric Surgery, Abdominoplasty
Effect of a Collagen-containing Supplement on Dermal Collagen Content in Metabolic Bariatric Surgery Patients Undergoing Corrective Aesthetic Surgery: A Randomized, Double-blind, Placebo-controlled Trial
This single-center, randomized, placebo-controlled trial evaluated whether perioperative supplementation with a collagen-based oral formulation affected dermal collagen content and postoperative outcomes in adults aged 18-65…
- Conditions
- Bariatric Surgery, Abdominoplasty, Collagen Synthesis, Skin Physiology
- Trial name
- COLLAGEN (NCT06787924)
- Testing
- Collagen hydrolyzed peptides, Starch
- Where
- Egypt
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
Skin Barrier to Water Loss, Skin Health
Apple Peptide Complex for Post-Surgical and Aesthetic Skin Recovery
This clinical study evaluates a topical botanical formulation for supporting skin recovery following invasive and non-invasive aesthetic procedures.
- Conditions
- Skin Barrier to Water Loss, Skin Health, Skin Discoloration, Skin Irritation
- Trial name
- APC-SKIN (NCT07807085)
- Testing
- Apple Peptide Complex Post-Aesthetic Care Protocol
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Grow Out Oils Clinical Aromatherapy Company
Breast Cancer, Quality of Life
The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction
The investigators conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of prepectoral breast reconstruction in women with breast cancer and high risk.
- Conditions
- Breast Cancer, Quality of Life, Surgery--Complications
- Trial name
- PreQ-20 (NCT04642508)
- Testing
- Prepectoral reconstruction
- Where
- Spain
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- University Hospital A Coruña
Breast Cancer, Surgery
Evaluation of ADM Soft Tissue Reinforcement
The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement.
- Conditions
- Breast Cancer, Surgery, Surgical Item, Retained
- Trial name
- NCT03494244
- Testing
- Direct-to-implant breast reconstruction, Acellular dermal matrix
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Mastectomy, Mastectomy Patient
A Study on Pain After Breast Reconstruction
The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer.
- Conditions
- Mastectomy, Mastectomy Patient, Mastectomy and Breast Reconstruction, Breast Reconstruction
- Trial name
- NCT06627582
- Testing
- PROMIS Scale v2.0 - Pain Intensity 3a, PROMIS 29+2, PROMIS Scale v2.0 - Nociceptive Pain Quality 5a
- Where
- 7 sites in United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
Mastectomy; Lymphedema, Breast Cancer
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of…
- Conditions
- Mastectomy; Lymphedema, Breast Cancer, Quality of Life
- Trial name
- NCT04356235
- Testing
- A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction, B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling, C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
- Where
- Hungary
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- National Institute of Oncology, Hungary
Breast/Surgery
Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon. 2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated…
- Trial name
- NCT05560633
- Testing
- No intervention
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Pain, Postoperative, Non-Opioid Pain Management
Virtual Reality After Breast Reconstruction Surgery
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction.
- Conditions
- Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
- Trial name
- VR4BR (NCT03801616)
- Testing
- Virtual Reality
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Breast Cancer
BREAST Choice Decision Tool R21 - AIM2
Breast reconstruction is a critical component of breast cancer treatment because it restores quality of life and body image after mastectomy.
- Trial name
- BREASTChoice (NCT06817226)
- Testing
- Pre-survey, BREASTChoice tool., Post-survey
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Breast Cancer, Gynecologic Cancer
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery
This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery After Surgery) protocols and postoperative followup via a smartphone app can offer 1) improved patient satisfaction, 2) virtual patient…
- Trial name
- ERAS-OncoRe (NCT03456167)
- Testing
- RecoverWell mobile app for follow-up care
- Where
- Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Alberta Health Services, Calgary