Clinical trials: Synthetic Mesh
Breast Cancer
Pre-pectoral Breast Reconstruction PART 2
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results…
- Trial name
- PreBRec (NCT02831426)
- Testing
- Two-stage with Acellular Dermal Matrix (CELLIS® Breast), Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
- Where
- United Kingdom
- Volunteers
- 86 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Large Hiatal Hernia
Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable…
- Trial name
- HIATUS (NCT05867225)
- Testing
- Laparoscopic hiatal hernia repair
- Where
- 26 sites in France
- Volunteers
- 256 people
- Sponsor
- University Hospital, Bordeaux
Rectum Cancer
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
- Trial name
- NCT03445936
- Testing
- Parietene Macro, Permacol
- Where
- 4 sites in Finland
- Volunteers
- 100 people
- Sponsor
- University of Oulu
Intestinal Obstruction, Pelvic Organ Prolapse
Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP
The purpose of the pilot study is to demonstrate the safety and efficacy of a biological mesh compared to a standard synthetic mesh for the planned procedure in the above-mentioned clinical picture.
- Conditions
- Intestinal Obstruction, Pelvic Organ Prolapse, Rectal Prolapse
- Trial name
- BioSynIRS (NCT06245577)
- Testing
- Laparoscopic mesh sacropexy (vagina, cervix) combined with resection rectopexy
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Evangelisches Klinikum Köln Weyertal gGmbH
Hernia Inguinal, Biologic Mesh
Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal Hernia
Inguinal hernia is one of the most common conditions in general surgery. In clinical practice, surgeons frequently face a dilemma: during the evaluation of a patient with unilateral symptomatic inguinal hernia, a contralateral…
- Trial name
- BiSAH (NCT07649434)
- Testing
- Biologic Mesh, Synthetic Mesh
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Xiangya Hospital of Central South University
Ventral Hernia
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias.
- Trial name
- NCT01794338
- Testing
- Strattice Arm, Bio-A Arm
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Wake Forest University Health Sciences
Incontinence
Synthetic Mesh Materials In Sling Surgery
The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first…
- Trial name
- NCT01348334
- Testing
- Synthetic sling surgery
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Ataturk Training and Research Hospital
Incisional Hernia After Diverting Stoma Closure
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer
- Trial name
- MEMBO (NCT02576184)
- Testing
- Biologic Mesh, Synthetic Mesh
- Where
- France
- Volunteers
- 381 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hernia, Ventral
Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited.
- Trial name
- CVHR (NCT02041494)
- Testing
- Ventralight, Strattice
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Hobart Harris
Hiatal Hernia, Paraesophageal Hernia
Study of Paraesophageal Hernia Repair With Small Intestine Submucosa
In 2006 this research group reported their initial findings of a multi-center prospective trial comparing primary repair and primary repair buttressed with a biologic mesh made from porcine small intestinal submucosa (SIS).
- Trial name
- PEH (NCT00786084)
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- University of Washington
Abdominal Wall Defect, Abdominal Wall Hernia
Abdominal Wall Reconstruction With PVDF Mesh in the Setting of Active Infection
The use of synthetic mesh to repair infected defects of the abdominal wall remains controversial. This study aimed to evaluate the short-term outcomes of using PVDF mesh to treat infected abdominal wall defects in the elective…
- Conditions
- Abdominal Wall Defect, Abdominal Wall Hernia, Abdominal Wall Infection, Abdominal Wall Fistula
- Trial name
- NCT05061264
- Testing
- Abdominal wall reconstruction
- Where
- Brazil
- Volunteers
- 76 people
- Sponsor
- University of Sao Paulo General Hospital
Abdominal Wall Defect, Abdominal Wall Infection
The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs. A Long-term Prospective Clinical Trial
Background: Abdominal wall reconstruction in patients presenting with enteric fistulas and mesh infection is challenging. There is a consensus that synthetic mesh must be avoided in infected operations.
- Conditions
- Abdominal Wall Defect, Abdominal Wall Infection, Abdominal Wall Fistula, Infection
- Trial name
- NCT03702153
- Testing
- Abdominal wall reconstruction
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- University of Sao Paulo General Hospital
Pelvic Organ Prolapse
Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year
This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.
- Trial name
- NCT00774215
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Atlantic Health System
Ventral Hernia, Postoperative Pain
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
- Trial name
- NCT01413412
- Testing
- Ventral hernia repair using full thickness skin graft, Ventral hernia repair using mesh
- Where
- Sweden
- Volunteers
- 50 people
- Sponsor
- Karolinska Institutet
Open Abdomen, Incisional Hernia
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
The aim of this clinical trial is to evaluate whether placement of a synthetic prophylactic onlay mesh during definitive fascial closure can reduce the incidence of incisional hernia in adult patients managed with an open abdomen…
- Conditions
- Open Abdomen, Incisional Hernia, Definitive Fascial Closure, Emergency Abdominal Surgery
- Trial name
- SHIELD (NCT07835334)
- Testing
- Definitive Fascial Closure Without Prophylactic Mesh, Prophylactic Onlay Mesh Placement
- Volunteers
- 30 people
- Sponsor
- Hospital San Juan de Dios Tenerife
Patients Undergoing Open Hernia Repair, Patients Undergoing Ventral or Inguinal Hernia Repair
Reducing Mesh Infections in Open Hernia Repairs
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection
- Trial name
- NCT01860469
- Testing
- vancomycin-soaked mesh, plain mesh
- Where
- Canada
- Sponsor
- University of Saskatchewan
Hernia, Ventral, Hernia Incisional
Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh
This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.
- Trial name
- NCT06409091
- Testing
- Medium weight or Heavy weight mesh
- Where
- United States
- Volunteers
- 1,496 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Breast Cancer
Biological Matrices Versus Synthetic Meshes
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months.
- Trial name
- BIOSYM (NCT05449691)
- Testing
- One-stage immediate breast reconstruction
- Where
- 5 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Pelvic Organ Prolapse
Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial
This is a Canadian, multi-centre, double-blind randomized controlled trial of an innovative vaginal surgery technique for correction of pelvic organ prolapse (POP) in women.
- Trial name
- COMET (NCT02965313)
- Testing
- SSLS Procedure, BSSVF-M Procedure
- Where
- Canada
- Volunteers
- 358 people
- Sponsor
- University of British Columbia