16 completed, 4 terminated, 1 unknown. 10 Not applicable, 5 Phase 4, 2 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 10 | Completed 7, Terminated 2, Unknown 1 |
| Phase 4 | 5 | Completed 3, Terminated 2 |
| Phase 3 | 2 | Completed 2 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers Amnion-Intermediate-Chorion, Amnion-Chorion-Amnion, Standard of Care - Diabetic Foot Ulcer, Venous Leg Ulcer | Phase 4 | Completed | Cellution Biologics | 292 | 2024-10-14 | 2026-04-13 |
| Breast Reconstruction Outcomes With and Without StratticE Strattice - Breast Neoplasms | Completed | Manchester University NHS Foundation Trust | 121 | 2016-08-19 | 2020-05-22 | |
| Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy strattice, No strattice - Parastomal Hernia, Terminal Colostomy | Not applicable | Completed | Centre Hospitalier Universitaire, Amiens | 81 | 2014-04-14 | 2026-06-12 |
| Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant - Breast Cancer | Not applicable | Completed | Karolinska University Hospital | 135 | 2014-04-01 | 2018-04-24 |
| Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap Biological mesh, Synthetic mesh - Abdominal Donor-site | Not applicable | Completed | Aarhus University Hospital | 29 | 2014-03-01 | 2020-01-09 |
| Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction - Mastectomy and Breast Reconstruction | Not applicable | Terminated | LifeCell | 131 | 2013-07-29 | 2019-12-04 |
| Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction Inframammary Fold Incision or Lateral Radial Incision, Lateral Radial Incision, Inframammary Fold Incision - Ductal Carcinoma in Situ - Category, Breast Cancer | Not applicable | Completed | Washington University School of Medicine | 79 | 2013-03-28 | 2018-04-18 |
| Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer Biological mesh assisted perineal closure, Primary perineal closure - Rectal Cancer | Phase 3 | Completed | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 104 | 2013-03-08 | 2021-08-17 |
| Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava) Strattice™ Reconstructive Tissue Matrix - Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction | Not applicable | Terminated | LifeCell | 36 | 2013-03-01 | 2017-05-25 |
| Reinforcement of Closure of Stoma Site Strattice™ Reconstructive Tissue Matrix, Standard Closure - Hernia | Phase 2 / Phase 3 | Completed | University of Birmingham | 790 | 2012-11-01 | 2018-10-11 |
| Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital Gastroesophageal Reflux Disease, Hiatal Hernia | Completed | University of Nebraska | 69 | 2012-05-22 | 2023-09-05 | |
| Use of Strattice Mesh in Paraesophageal Hernia Surgery Esophageal Hernia, Hernia, Esophageal | Completed | University of Nebraska | 35 | 2012-03-05 | 2023-09-06 | |
| Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR) Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh - Hernia, Surgical Wound Dehiscence | Phase 4 | Terminated | LifeCell | 37 | 2010-03-01 | 2013-11-19 |
| Outcomes in Rotator Cuff Repair Using Graft Reinforcement Conexa Reconstructive Tissue Matrix - Rotator Cuff Tear | Not applicable | Completed | Stryker Trauma and Extremities | 61 | 2009-10-01 | 2015-01-26 |
| Hernia Repair in Multiply Morbid Patients Strattice Reconstructive Tissue Matrix (Hernia Repair), Proceed Surgical Mesh (Hernia repair) - Ventral Hernia | Phase 4 | Terminated | LifeCell | 23 | 2009-08-01 | 2013-11-20 |
| Parastomal Reinforcement With Strattice Strattice Reconstructive Matrix, Standard ostomy creation - Parastomal Hernia | Phase 4 | Completed | LifeCell | 120 | 2008-12-01 | 2015-09-28 |
| Strattice in Repair of Inguinal Hernias Inguinal hernia repair with Ultrapro, Inguinal hernia repair with Strattice - Hernia, Inguinal | Phase 4 | Completed | LifeCell | 172 | 2008-04-01 | 2016-05-10 |
| Immediate Postmastectomy Breast Reconstruction (Strattice Breast) LTM - a porcine-based surgical mesh - Breast Cancer | Completed | LifeCell | 17 | 2007-10-01 | 2016-11-08 | |
| Repair of Infected or Contaminated Hernias LTM (Strattice Reconstructive Tissue Matrix) - Hernia | Not applicable | Completed | LifeCell | 83 | 2007-09-01 | 2015-12-01 |
| Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease surgery (Pore Excision, Curettage, and Injection of Cymetra) - Pilonidal Sinus | Not applicable | Unknown | Matino, James, M.D. | 50 | 2007-01-01 | 2007-06-28 |
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Breast Neoplasms (6) · Hernia (3) · Hernia, Hiatal (2) · Diabetic Foot (1) · Gastroesophageal Reflux (1) · Genital Neoplasms, Female (1) · Hernia, Inguinal (1) · Hernia, Ventral (1) · Incisional Hernia (1) · Jacobs syndrome (1) · Pilonidal Sinus (1) · Rectal Neoplasms (1) · Rotator Cuff Injuries (1) · Surgical Wound (1) · Surgical Wound Dehiscence (1)
strattice (3) · Mammaplasty (2) · Carboplatin (1) · Curettage (1) · Diffusion Tensor Imaging (1) · Drug Implants (1) · Herniorrhaphy (1) · Indocyanine Green (1) · Mastectomy (1) · Mastectomy, Subcutaneous (1) · Plastic Surgery Procedures (1) · Standard of Care (1) · Surgical Procedures, Operative (1) · Sutures (1) · Thrombopoietin (1)
United States (12) · United Kingdom (4) · France (3) · Netherlands (3) · Denmark (2) · Germany (2) · Italy (2) · Spain (1) · Sweden (1)
Dmitry Oleynikov, MD (2) · Andrea Spano, MD (1) · Angus JM Watson (1) · Baljit Singh, M.D. PhD (1) · Berndt Reith (1) · Charles Bellows, MD, FACS (1) · Dion G Morton, MD (1) · Donna Jacobs (1) · Fredrik Lohmander, MD (1) · Gijsbert D. Musters, M.D. (1) · Harm J. Rutten, M.D. PhD (1) · James Fleshman, MD (1) · James J Matino, MD (1) · Johannes Jeekel (1) · John Sperling, MD (1)
PMID 22763262, PMID 21222008, PMID 22415440, PMID 24819103, PMID 25163547, PMID 26924621, PMID 29878989, PMID 32035551, PMID 32762012, PMID 34596671, PMID 42290606