Parastomal Reinforcement With Strattice | NCT00771407

Label	Type	Description	Intervention Names
Strattice fascial inlay	Active Comparator	Strattice will be placed as a fascial inlay to support the ostomy site	Device: Strattice Reconstructive Matrix
Standard ostomy construction	Other	Ostomy will be created in the standard fashion	Other: Standard ostomy creation

Name	Type	Description	Arm Group Labels	Other Names
Strattice Reconstructive Matrix	Device	Strattice will be placed as a fascial inlay to support stoma sites	Strattice fascial inlay

Measure	Description	Time Frame
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.		24 months

Measure	Description	Time Frame
Stoma Complications		30 days
Stoma Complications		more than 1 month postoperatively
Stoma Quality of Life

Name	Affiliation	Role
James Fleshman, MD	Washington University, St Louis MO	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama		Mobile	Alabama		United States
Office of Dr Phillip Fleshner

PubMed Identifier	Type	Citation	Retractions
24819103	Derived	Fleshman JW, Beck DE, Hyman N, Wexner SD, Bauer J, George V; PRISM Study Group. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum. 2014 May;57(5):623-31. doi: 10.1097/DCR.0000000000000106.
22763262

ID	Title	Description
FG000	Strattice Fascial Inlay	Strattice placed as a fascial inlay to support the ostomy site
FG001	Standard Ostomy Construction	Ostomy created in the standard fashion

ID	Title	Description
BG000	Strattice Fascial Inlay	Strattice placed as a fascial inlay to support the ostomy site
BG001	Standard Ostomy Construction	Ostomy created in the standard fashion
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00055 BG00158 BG002113

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0002 affected55 at risk EG0010 affected58 at risk
Myocardial Infarction	Cardiac disorders	EG0001 affected55 at risk EG0011 affected58 at risk
Abdominal Distension	Gastrointestinal disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Application Site Bleeding	General disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Abdominal Abscess	Infections and infestations	EG0000 affected55 at risk EG0011 affected58 at risk
Accidental Overdose	Injury, poisoning and procedural complications	EG0001 affected55 at risk EG0010 affected58 at risk
Dehydration	Metabolism and nutrition disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected55 at risk EG0011 affected58 at risk
Cerebrovascular Accident	Nervous system disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Depression	Psychiatric disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Acute Renal Failure	Renal and urinary disorders	EG0003 affected55 at risk EG0010 affected58 at risk
Epididymitis	Reproductive system and breast disorders	EG0000 affected55 at risk EG0011 affected58 at risk
COPD	Respiratory, thoracic and mediastinal disorders	EG0002 affected55 at risk EG0010 affected58 at risk
Malignant Tumour Excision	Surgical and medical procedures	EG0001 affected55 at risk EG0010 affected58 at risk
Deep Vein Thrombosis	Vascular disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Tachycardia	Cardiac disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Ventricular Tachycardia	Cardiac disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Pyrexia	General disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Malnutrition	Metabolism and nutrition disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Spinal Cord Compression	Nervous system disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Radiotherapy	Surgical and medical procedures	EG0001 affected55 at risk EG0010 affected58 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Pelvic Pain	Reproductive system and breast disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Vesical Fistula	Renal and urinary disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Mental Status Changes	Psychiatric disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Self Injurious Behaviour	Psychiatric disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Anal Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected55 at risk EG0011 affected58 at risk
Bladder Cancer Stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 affected55 at risk EG0010 affected58 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected55 at risk EG0010 affected58 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected55 at risk EG0010 affected58 at risk
Metastases to Ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected55 at risk EG0010 affected58 at risk
Prostate Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected55 at risk EG0011 affected58 at risk
Rectal Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 affected55 at risk EG0011 affected58 at risk
Rectal Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected55 at risk EG0010 affected58 at risk
Spinal Cord Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0003 affected55 at risk EG0010 affected58 at risk
Abdominal Pain	Gastrointestinal disorders	EG0003 affected55 at risk EG0012 affected58 at risk
Constipation	Gastrointestinal disorders	EG0000 affected55 at risk EG0012 affected58 at risk
Crohn's Disease	Gastrointestinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Diarrhoea	Gastrointestinal disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Dysphagia	Gastrointestinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Enterocutaneous Fistula	Gastrointestinal disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Ileorectal Fistula	Gastrointestinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Ileus	Gastrointestinal disorders	EG0003 affected55 at risk EG0013 affected58 at risk
Intestinal Obstruction	Gastrointestinal disorders	EG0004 affected55 at risk EG0012 affected58 at risk
Ischiorectal Hernia	Gastrointestinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Nausea	Gastrointestinal disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Odynophagia	Gastrointestinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Proctitis Ulcerative	Gastrointestinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	EG0002 affected55 at risk EG0018 affected58 at risk
Small Intestinal Perforation	Gastrointestinal disorders	EG0001 affected55 at risk EG0010 affected58 at risk
Vomiting	Gastrointestinal disorders	EG0000 affected55 at risk EG0011 affected58 at risk
Acinetobacter Bacteraemia	Infections and infestations	EG0001 affected55 at risk EG0010 affected58 at risk
Administration Site Infection	Infections and infestations	EG0001 affected55 at risk EG0010 affected58 at risk
Bacteraemia	Infections and infestations	EG0000 affected55 at risk EG0011 affected58 at risk
Cellulitis	Infections and infestations	EG0000 affected55 at risk EG0011 affected58 at risk
Clostridium Difficile Colitis	Infections and infestations	EG0002 affected55 at risk EG0010 affected58 at risk
Herpes Zoster	Infections and infestations	EG0001 affected55 at risk EG0010 affected58 at risk
Osteomyelitis	Infections and infestations	EG0002 affected55 at risk EG0010 affected58 at risk
Pelvic Abscess	Infections and infestations	EG0002 affected55 at risk EG0011 affected58 at risk
Perianal Abscess	Infections and infestations	EG0001 affected55 at risk EG0010 affected58 at risk
Pneumonia	Infections and infestations	EG0007 affected55 at risk EG0010 affected58 at risk
Postoperative Wound Infection	Infections and infestations	EG0001 affected55 at risk EG0012 affected58 at risk
Pyelonephritis	Infections and infestations	EG0001 affected55 at risk EG0010 affected58 at risk
Sepsis	Infections and infestations	EG0001 affected55 at risk EG0012 affected58 at risk
Urinary Tract Infection	Infections and infestations	EG0003 affected55 at risk EG0010 affected58 at risk
Urosepsis	Infections and infestations	EG0002 affected55 at risk EG0010 affected58 at risk
Wound Infection	Infections and infestations	EG0002 affected55 at risk EG0010 affected58 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	EG0000 affected55 at risk EG0011 affected58 at risk
Femur Fracture	Injury, poisoning and procedural complications	EG0001 affected55 at risk EG0010 affected58 at risk
Gastrointestinal Stoma Complications	Injury, poisoning and procedural complications	EG0007 affected55 at risk EG0011 affected58 at risk
Incisional Hernia	Injury, poisoning and procedural complications	EG0003 affected55 at risk EG0016 affected58 at risk
Joint Dislocation	Injury, poisoning and procedural complications	EG0001 affected55 at risk EG0010 affected58 at risk
Open Wound	Injury, poisoning and procedural complications	EG0000 affected55 at risk EG0011 affected58 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG00018 affected55 at risk EG00110 affected58 at risk
Tachycardia	Cardiac disorders	EG0007 affected55 at risk EG0019 affected58 at risk
Abdominal Distension	Gastrointestinal disorders	EG00013 affected55 at risk EG0019 affected58 at risk
Asthenia	General disorders	EG0004 affected55 at risk EG0015 affected58 at risk
Abdominal Abscess	Infections and infestations	EG0001 affected55 at risk EG0013 affected58 at risk
Leukocytosis	Blood and lymphatic system disorders	EG0006 affected55 at risk EG0013 affected58 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0003 affected55 at risk EG0014 affected58 at risk
Abdominal Pain	Gastrointestinal disorders	EG00020 affected55 at risk EG00122 affected58 at risk
Constipation	Gastrointestinal disorders	EG0004 affected55 at risk EG0018 affected58 at risk
Diarrhoea	Gastrointestinal disorders	EG0003 affected55 at risk EG0019 affected58 at risk
Dyspepsia	Gastrointestinal disorders	EG0003 affected55 at risk EG0012 affected58 at risk
Flatulence	Gastrointestinal disorders	EG0002 affected55 at risk EG0013 affected58 at risk
Haematochezia	Gastrointestinal disorders	EG0000 affected55 at risk EG0013 affected58 at risk
Ileus	Gastrointestinal disorders	EG0006 affected55 at risk EG0014 affected58 at risk
Intestinal Obstruction	Gastrointestinal disorders	EG0005 affected55 at risk EG0012 affected58 at risk
Nausea	Gastrointestinal disorders	EG00029 affected55 at risk EG00130 affected58 at risk
Proctalgia	Gastrointestinal disorders	EG0005 affected55 at risk EG0015 affected58 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	EG0004 affected55 at risk EG0017 affected58 at risk
Vomiting	Gastrointestinal disorders	EG00021 affected55 at risk EG00120 affected58 at risk
Chest Pain	General disorders	EG0003 affected55 at risk EG0013 affected58 at risk
Fatigue	General disorders	EG0009 affected55 at risk EG00115 affected58 at risk
Oedema Peripheral	General disorders	EG0003 affected55 at risk EG0013 affected58 at risk
Pyrexia	General disorders	EG00013 affected55 at risk EG00110 affected58 at risk
Cellulitis	Infections and infestations	EG0003 affected55 at risk EG0014 affected58 at risk
Pneumonia	Infections and infestations	EG0004 affected55 at risk EG0013 affected58 at risk
Postoperative Wound Infection	Infections and infestations	EG0003 affected55 at risk EG0014 affected58 at risk
Sepsis	Infections and infestations	EG0001 affected55 at risk EG0013 affected58 at risk
Urinary Tract Infection	Infections and infestations	EG00013 affected55 at risk EG00113 affected58 at risk
Urosepsis	Infections and infestations	EG0003 affected55 at risk EG0010 affected58 at risk
Wound Infection	Infections and infestations	EG0003 affected55 at risk EG0012 affected58 at risk
Gastrointestinal Stoma Complications	Injury, poisoning and procedural complications	EG00018 affected55 at risk EG00121 affected58 at risk
Incision Site Pain	Injury, poisoning and procedural complications	EG0005 affected55 at risk EG0011 affected58 at risk
Incisional Hernia	Injury, poisoning and procedural complications	EG0008 affected55 at risk EG0017 affected58 at risk
Procedural Pain	Injury, poisoning and procedural complications	EG0003 affected55 at risk EG0015 affected58 at risk
Procedural Site Reaction	Injury, poisoning and procedural complications	EG00013 affected55 at risk EG00112 affected58 at risk
Abnormal Breathing	Investigations	EG0000 affected55 at risk EG0013 affected58 at risk
Oxygen Saturation Decreased	Investigations	EG0001 affected55 at risk EG0015 affected58 at risk
Urine Output Decreased	Investigations	EG0005 affected55 at risk EG0013 affected58 at risk
Anorexia	Metabolism and nutrition disorders	EG0004 affected55 at risk EG0011 affected58 at risk
Decreased Appetite	Metabolism and nutrition disorders	EG0003 affected55 at risk EG0012 affected58 at risk
Dehydration	Metabolism and nutrition disorders	EG0008 affected55 at risk EG00113 affected58 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0001 affected55 at risk EG0014 affected58 at risk
Hypocalcaemia	Metabolism and nutrition disorders	EG0004 affected55 at risk EG0014 affected58 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0006 affected55 at risk EG0015 affected58 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0004 affected55 at risk EG0011 affected58 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0003 affected55 at risk EG0014 affected58 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0004 affected55 at risk EG0015 affected58 at risk
Malnutrition	Metabolism and nutrition disorders	EG0001 affected55 at risk EG0014 affected58 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0003 affected55 at risk EG0012 affected58 at risk
Dizziness	Nervous system disorders	EG0005 affected55 at risk EG0017 affected58 at risk
Headache	Nervous system disorders	EG0005 affected55 at risk EG0012 affected58 at risk
Anxiety	Psychiatric disorders	EG0002 affected55 at risk EG0013 affected58 at risk
Confused State	Psychiatric disorders	EG0001 affected55 at risk EG0015 affected58 at risk
Depression	Psychiatric disorders	EG0005 affected55 at risk EG0013 affected58 at risk
Insomnia	Psychiatric disorders	EG0004 affected55 at risk EG0014 affected58 at risk
Haematuria	Renal and urinary disorders	EG0002 affected55 at risk EG0016 affected58 at risk
Acute Renal Failure	Renal and urinary disorders	EG0004 affected55 at risk EG0014 affected58 at risk
Urinary Incontinence	Renal and urinary disorders	EG0001 affected55 at risk EG0013 affected58 at risk
Urinary Retention	Renal and urinary disorders	EG0003 affected55 at risk EG0014 affected58 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	EG0003 affected55 at risk EG0011 affected58 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0005 affected55 at risk EG0013 affected58 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0003 affected55 at risk EG0014 affected58 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	EG0003 affected55 at risk EG0011 affected58 at risk
Erythema	Skin and subcutaneous tissue disorders	EG0003 affected55 at risk EG0011 affected58 at risk
Pruritis	Skin and subcutaneous tissue disorders	EG0000 affected55 at risk EG0013 affected58 at risk
Rash	Skin and subcutaneous tissue disorders	EG0000 affected55 at risk EG0013 affected58 at risk
Incisional Drainage	Surgical and medical procedures	EG0004 affected55 at risk EG0012 affected58 at risk
Hypertension	Vascular disorders	EG0004 affected55 at risk EG0012 affected58 at risk
Hypotension	Vascular disorders	EG00014 affected55 at risk EG0016 affected58 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Strattice Fascial Inlay	Strattice placed as a fascial inlay to support the ostomy site			37	55	54	55
EG001	Standard Ostomy Construction	Ostomy created in the standard fashion			37	58	55	58