Clinical trials: Reconstructive Breast Surgery
Reconstructive Surgical Procedures
DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.
Patients selected for DIEP breast reconstruction were examined with preoperative CTA, Doppler Ultrasound, dynamic infrared thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) for perforator mapping.
- Trial name
- NCT04115995
- Testing
- Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)
- Where
- Norway
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital of North Norway
Breast Cancer Female
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT).
- Trial name
- EVE (NCT05003635)
- Testing
- EVEBRA device
- Where
- 3 sites in Netherlands
- Volunteers
- 90 people
- Sponsor
- Maastricht University Medical Center
Breast Cancer, Reconstructive Surgery
AFT: Introduction of a Full Breast Reconstructive Method
A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion.
- Conditions
- Breast Cancer, Reconstructive Surgery, Breast Reconstruction
- Trial name
- BREAST-II (NCT04261829)
- Testing
- Autologous Fat Transfer
- Where
- 8 sites in Netherlands
- Volunteers
- 350 people
- Sponsor
- Maastricht University Medical Center
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
BIOCHROMADERM® PMCF STUDY
The goal of this observational study is to: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; To confirm the…
- Trial name
- NCT07261904
- Where
- 3 sites in France
- Volunteers
- 115 people
- Sponsor
- Laboratoires BIOTIC Phocea
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, Reconstructive Breast Surgery
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.
- Trial name
- NSM (NCT01796977)
- Testing
- OxyGenesys Dissolved Oxygen Dressing, Standard Gauze Dressing
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halyard Health
The Impact of Adipose Tissue Quality on Fat Graft Retention
Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery
The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the…
- Trial name
- LipoTech (NCT05286424)
- Testing
- fat grafting
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding…
- Trial name
- NCT01853436
- Testing
- Strattice™ Reconstructive Tissue Matrix
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- LifeCell
Breast Cancer, Mastectomy; Lymphedema
Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries
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
- Breast Cancer, Mastectomy; Lymphedema, Quality of Life, Patient Satisfaction
- Trial name
- NCT04345081
- Testing
- Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery
- Where
- Hungary
- Volunteers
- 110 people
- Sponsor
- National Institute of Oncology, Hungary
Breast Cancer
Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
Primary Objective: To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only…
- Trial name
- NCT00542542
- Testing
- Paravertebral Block, Propofol, Fentanyl
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- M.D. Anderson Cancer Center
Radiation Dermatitis, Skin Microbiome
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find…
- Conditions
- Radiation Dermatitis, Skin Microbiome, Breast Cancer, Reconstructive Surgery
- Trial name
- NCT05032768
- Testing
- post-operative radiotherapy
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
Breast Cancer
The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery
This paper will present a specific tool for evaluation of cosmetic results after breast conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap.
- Trial name
- TBS (NCT02853227)
- Testing
- digital photography
- Volunteers
- 376 people
- Sponsor
- Sykehuset Telemark
Pain, Postoperative
Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery
The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs blocks as well as the Serratus Anterior Plane Block have extended the application of perioperative regional anesthesia to provide…
- Trial name
- NCT03183596
- Testing
- Bupivacaine, Dexamethasone
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
Breast Neoplasms, Mastectomy
Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.
This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation.
- Conditions
- Breast Neoplasms, Mastectomy, Mammaplasty, Nipple Disorder
- Trial name
- RECHIAL (NCT07008339)
- Testing
- Areola Micropigmentation, Hyaluronic Acid Filler Injection
- Where
- Spain
- Volunteers
- 138 people
- Sponsor
- Germans Trias i Pujol Hospital
Breast Neoplasms, Carcinoma, Ductal, Breast
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
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…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
- Trial name
- RESTORE-2 (NCT00616135)
- Testing
- ADRC-Enhanced Autologous Fat Transplant
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 71 people
- Sponsor
- Cytori Therapeutics
Pain, Postoperative, Length of Stay
ICNBs for Post-op Pain in Breast Surgery
The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the…
- Trial name
- NCT04606836
- Testing
- Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
Surgery, Plastic, Mastectomy
Nerve Blocks in Alloplastic Breast Reconstruction
Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operatively.
- Conditions
- Surgery, Plastic, Mastectomy, Nerve Block, Breast Reconstruction
- Trial name
- NCT04860843
- Testing
- Thoracic paravertebral block, Pecs block
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of British Columbia
Breast Reconstruction, Skin Perfusion
Microcirculation of the Abdominal Skin After Deep Inferior Epigastric Artery Perforator Flap Procedure
The purpose of this study was to perform a quantitative perfusion study of the undermined abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction patients in order to obtain more knowledge on…
- Trial name
- NCT02481284
- Testing
- Laser Doppler perfusion imaging
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- Oslo University Hospital
Breast Cancer, Mastectomy
Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery
Over the last two decades in the field of oncology, the prevention, diagnosis, treatment and rehabilitation have reached a remarkable development, improving healing rates and reducing the number of deaths from cancer.
- Conditions
- Breast Cancer, Mastectomy, Breast Implantation, Edema
- Trial name
- BREASTAPE (NCT03477565)
- Testing
- Kinesio tape lymphatic drainage technique application
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- IRCCS San Raffaele