Clinical trials: Skin Flaps, active
DIEP Flap, Breast Reconstruction
ORASIS in Breast Reconstruction
The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction and its potential effects on surgical precision, surgeon…
- Conditions
- DIEP Flap, Breast Reconstruction, Breast Cancer
- Trial name
- NCT07670754
- Testing
- Use of ORASIS Device
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Breast Cancer, Exercise
The Effect of a Post-operative Exercise Programme Versus Standard Care on Physical Fitness of Patients With Breast Cancer Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Reconstruction Surgery
All patients undergoing mastectomy for breast cancer should be offered the option of reconstructive surgery. The Deep Inferior Epigastric Perforator Flap or DIEP reconstruction as it is commonly referred to, is becoming the…
- Trial name
- EXERCISE DIEP (NCT07672392)
- Testing
- Structured individualised 12-week post operative exercise programme
- Where
- Ireland
- Volunteers
- 78 people
- Sponsor
- Royal College of Surgeons, Ireland
Postoperative Bleeding, Skin Cancer Face
Tranexamic Acid in Nasal Mohs Reconstruction
This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.
- Trial name
- NCT06057675
- Testing
- Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine), Control (1% lidocaine with 1:100,000 epinephrine)
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Breast Cancer
Application of VascuLens 2.0, A Mixed Reality System for Surgical Guidance During DIEP Flap Harvest
This study incorporates the use of the VascuLens system, which relies on a mixed reality headset and software system, during the pre-operative stage of DIEP flap surgery.
- Trial name
- VascuLens RCT (NCT07080463)
- Testing
- vasculens and cta
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- University of British Columbia
Prophylactic Mastectomy
Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
Breast cancer is the most common form of cancer among women. Five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes BRCA1/2 accounting for 2-5% of all breast…
- Trial name
- NCT05162677
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- Umeå University
Ingrown Toenail
P : Ingrown Toenail Patient I : Bird Flap Surgery C : Noel Winograd Method O : Recurrence, Complications, Functional Outcome, Pain,
The treatment of ingrown toenails is highly diverse, with numerous surgical techniques described in the literature alongside conservative approaches.
- Trial name
- ITN (NCT06862232)
- Testing
- Modified Winograd "Bird Flap" Technique, Classic Winograd Technique, Modified Noel Technique
- Where
- Turkey (Türkiye)
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Kutahya City Hospital
Breast Neoplasms, Breast Reconstruction
DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction
This multicenter retrospective observational study will develop and validate a CTA-based quantitative risk score-the DIEP Morphological Deviation Score (DIEP-MDS)-to estimate the risk of flap-related vascular compromise and flap…
- Conditions
- Breast Neoplasms, Breast Reconstruction, Postoperative Complications
- Trial name
- DIEP-MDS (NCT07761390)
- Where
- 20 sites in China
- Volunteers
- 1,500 people
- Sponsor
- Zhuliling
Skin Necrosis, Breast Reconstruction
B4P Trial - BLOOM43 for Preconditioning
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer.
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Trial name
- NCT07340632
- Testing
- BLOOM43
- Volunteers
- 60 people
- Sponsor
- Plexaa Ltd
Seroma
fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma
Rationale: Flap fixation significantly reduces the incidence of seroma formation after mastectomy. Therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle.
- Trial name
- ANNIE (NCT05941351)
- Testing
- flap fixation
- Where
- Netherlands
- Volunteers
- 361 people
- Sponsor
- Zuyderland Medisch Centrum
Breast Cancer, Breast Neoplasms, Breast Reconstruction
Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction, Robotic Surgery
- Trial name
- REBORN (NCT07230535)
- Testing
- Robotic Assisted Nipple Sparing Mastectomy, Standarding Open Nipple Sparing Mastectomy
- Where
- Ireland
- Volunteers
- 250 people
- Sponsor
- Beaumont Hospital
Breast Cancer, Breast Reconstruction
The Outcomes of Fat Grafting Combined With Latissimus Dorsi Muscle Flap for Delayed Breast Reconstruction After Mastectomy
The outcomes of fat grafting combined with latissimus dorsi muscle flap for delayed breast reconstruction after mastectomy
- Trial name
- NCT07331753
- Testing
- Fat grafting combined with latissimus dorsi muscle flap
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Sohag University
Breast Cancer
Autologous vs. Implant-based Breast Reconstruction
Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective.
- Trial name
- GoBreast II (NCT06195865)
- Testing
- DIEP-flap, Implant
- Where
- 2 sites in Sweden
- Volunteers
- 250 people
- Sponsor
- Vastra Gotaland Region
Wound Healing
Basement Membrane Regeneration for Wound Repair
This study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of autologous basement membrane regeneration technology (epidermal basal cell suspension prepared using a…
- Trial name
- NCT07551284
- Testing
- Autologous Epidermal Basal Cell Suspension
- Volunteers
- 1,000 people
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
Disability or Chronic Disease Leading to Disablement, Pressure Ulcer
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents
People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers.
- Conditions
- Disability or Chronic Disease Leading to Disablement, Pressure Ulcer, Osteomyelitis
- Trial name
- NCT05713149
- Testing
- Surgical flap and anti-bacterial agents
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Institut de Sante Parasport Connecte Synergies
Oral Cancer, Oral Cavity Cancer
Radial Forearm Donor Site Closure
The radial forearm free flap (RFFF) is widely used in head and neck reconstruction. Its thinness, pliability, pedicle length, and vessel size are particularly suited for oropharyngeal and oral cavity reconstruction.
- Conditions
- Oral Cancer, Oral Cavity Cancer, Donor Site Complication
- Trial name
- NCT05740033
- Testing
- Split-Thickness Skin Graft for Radial Forearm Donor Site Closure, Hatchet Flap for Radial Forearm Donor Site Closure
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- University of British Columbia
Stage II Cutaneous Melanoma
COmparison of the Use of a PERforator Flap Versus Total Skin GRAft in the Management of Loss of Substance After Resection of Cutaneous Melanoma - Pilot Study
Melanoma is an aggressive and potentially fatal skin cancer and was the fifth most commonly diagnosed cancer among both men and women in the United States in 2022.
- Trial name
- COPERGRAM1 (NCT07354152)
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Nantes University Hospital
Breast Cancer Surgery, Reconstruction Breast Surgery
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or…
- Conditions
- Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction
- Trial name
- S-DIEP (NCT06930378)
- Testing
- Nerve Suture
- Where
- Switzerland
- Volunteers
- 63 people
- Sponsor
- Patricia Esther Engels
Breast Cancer, Physiotherapy
Evaluation of the Impact of Pre-habilitation Using Physiotherapy and Mechanical Stimulation on Shoulder Pain and Mobility in Patients Undergoing Breast Reconstruction Using a Latissimus Dorsi Flap
Each year in France, nearly 59,000 new cases of breast cancer are diagnosed, and approximately 22,000 mastectomies are performed. Among these patients, 30% choose to undergo breast reconstruction.
- Conditions
- Breast Cancer, Physiotherapy, Breast Reconstruction, Latissimus Dorsi Flap
- Trial name
- PREHAB KINELGD (NCT07418060)
- Testing
- Prehabilitation with physiotherapy including mechanostimulation, No Prehabilitation with physiotherapy including mechanostimulation
- Where
- 2 sites in France
- Volunteers
- 96 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Camptodactyly
Treatment of Camptodactyly With Radial Longitudinal Flap Versus Full-Thickness Skin Graft
The goal of this randomized clinical trial is to compare two surgical techniques used for skin coverage after surgical correction of camptodactyly, a condition in which one or more fingers remain bent and cannot be fully…
- Trial name
- NCT07786701
- Testing
- Radial Longitudinal Flap, Full-Thickness Skin Graft
- Where
- Brazil
- Volunteers
- 42 people
- Sponsor
- Associação de Assistência a Criança Deficiente
Breast Cancer, Oncoplastic Breast Surgery
Scarless Advanced Breast Extended Oncoplasty: The ScarABEO Study
Breast conserving surgery followed by radiotherapy is the gold standard treatment for early breast cancer. Cases with unfavorable tumor volume to breast volume ratio or challenging localizations are at higher risk of margin…
- Conditions
- Breast Cancer, Oncoplastic Breast Surgery, Oncoplastic Breast-conserving Surgery, Chest Wall Perforator Flap
- Trial name
- ScarABEO (NCT06906237)
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Istituto Oncologico Veneto IRCCS