Trial Outcomes & Findings for Parastomal Reinforcement With Strattice (NCT NCT00771407)
NCT ID: NCT00771407
Last Updated: 2015-09-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
24 months
Results posted on
2015-09-28
Participant Flow
7 subjects failed eligibility to continue to protocol-specific surgery after randomization.
Participant milestones
| Measure |
Strattice Fascial Inlay
Strattice placed as a fascial inlay to support the ostomy site
|
Standard Ostomy Construction
Ostomy created in the standard fashion
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
40
|
35
|
|
Overall Study
NOT COMPLETED
|
20
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parastomal Reinforcement With Strattice
Baseline characteristics by cohort
| Measure |
Strattice Fascial Inlay
n=55 Participants
Strattice placed as a fascial inlay to support the ostomy site
|
Standard Ostomy Construction
n=58 Participants
Ostomy created in the standard fashion
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.25 years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
59.14 years
STANDARD_DEVIATION 14.36 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
58 participants
n=7 Participants
|
113 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Efficacy Evaluable Population (received assigned treatment, completed all protocol-required evaluations, no major protocol violations).
Outcome measures
| Measure |
Strattice Fascial Inlay
n=49 Participants
Strattice will be placed as a fascial inlay to support the ostomy site
|
Standard Ostomy Construction
n=53 Participants
Ostomy will be created in the standard fashion
|
|---|---|---|
|
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
|
6 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: more than 1 month postoperativelyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Serially over 24 monthsOutcome measures
Outcome data not reported
Adverse Events
Strattice Fascial Inlay
Serious events: 37 serious events
Other events: 54 other events
Deaths: 0 deaths
Standard Ostomy Construction
Serious events: 37 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Strattice Fascial Inlay
n=55 participants at risk
Strattice placed as a fascial inlay to support the ostomy site
|
Standard Ostomy Construction
n=58 participants at risk
Ostomy created in the standard fashion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
2/55
|
0.00%
0/58
|
|
Cardiac disorders
Myocardial Infarction
|
1.8%
1/55
|
1.7%
1/58
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.8%
1/55
|
0.00%
0/58
|
|
General disorders
Application Site Bleeding
|
1.8%
1/55
|
0.00%
0/58
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/55
|
1.7%
1/58
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
1.8%
1/55
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/55
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
1/55
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/55
|
1.7%
1/58
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/55
|
1.7%
1/58
|
|
Psychiatric disorders
Depression
|
0.00%
0/55
|
1.7%
1/58
|
|
Renal and urinary disorders
Acute Renal Failure
|
5.5%
3/55
|
0.00%
0/58
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/55
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
3.6%
2/55
|
0.00%
0/58
|
|
Surgical and medical procedures
Malignant Tumour Excision
|
1.8%
1/55
|
0.00%
0/58
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.8%
1/55
|
0.00%
0/58
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/55
|
1.7%
1/58
|
|
Cardiac disorders
Tachycardia
|
1.8%
1/55
|
0.00%
0/58
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/55
|
1.7%
1/58
|
|
General disorders
Pyrexia
|
1.8%
1/55
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/55
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/55
|
1.7%
1/58
|
|
Nervous system disorders
Spinal Cord Compression
|
1.8%
1/55
|
0.00%
0/58
|
|
Surgical and medical procedures
Radiotherapy
|
1.8%
1/55
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.8%
1/55
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/55
|
1.7%
1/58
|
|
Reproductive system and breast disorders
Pelvic Pain
|
1.8%
1/55
|
0.00%
0/58
|
|
Renal and urinary disorders
Vesical Fistula
|
1.8%
1/55
|
0.00%
0/58
|
|
Psychiatric disorders
Mental Status Changes
|
1.8%
1/55
|
0.00%
0/58
|
|
Psychiatric disorders
Self Injurious Behaviour
|
0.00%
0/55
|
1.7%
1/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal Cancer Metastatic
|
0.00%
0/55
|
1.7%
1/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Stage IV
|
3.6%
2/55
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
1.8%
1/55
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
1.8%
1/55
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Ovary
|
1.8%
1/55
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.00%
0/55
|
1.7%
1/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Metastatic
|
3.6%
2/55
|
1.7%
1/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Recurrent
|
1.8%
1/55
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal Cord Neoplasm
|
5.5%
3/55
|
0.00%
0/58
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.5%
3/55
|
3.4%
2/58
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/55
|
3.4%
2/58
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/55
|
1.7%
1/58
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55
|
0.00%
0/58
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/55
|
1.7%
1/58
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
1.8%
1/55
|
0.00%
0/58
|
|
Gastrointestinal disorders
Ileorectal Fistula
|
0.00%
0/55
|
1.7%
1/58
|
|
Gastrointestinal disorders
Ileus
|
5.5%
3/55
|
5.2%
3/58
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
7.3%
4/55
|
3.4%
2/58
|
|
Gastrointestinal disorders
Ischiorectal Hernia
|
0.00%
0/55
|
1.7%
1/58
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55
|
0.00%
0/58
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/55
|
1.7%
1/58
|
|
Gastrointestinal disorders
Proctitis Ulcerative
|
0.00%
0/55
|
1.7%
1/58
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.6%
2/55
|
13.8%
8/58
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
1.8%
1/55
|
0.00%
0/58
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/55
|
1.7%
1/58
|
|
Infections and infestations
Acinetobacter Bacteraemia
|
1.8%
1/55
|
0.00%
0/58
|
|
Infections and infestations
Administration Site Infection
|
1.8%
1/55
|
0.00%
0/58
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/55
|
1.7%
1/58
|
|
Infections and infestations
Cellulitis
|
0.00%
0/55
|
1.7%
1/58
|
|
Infections and infestations
Clostridium Difficile Colitis
|
3.6%
2/55
|
0.00%
0/58
|
|
Infections and infestations
Herpes Zoster
|
1.8%
1/55
|
0.00%
0/58
|
|
Infections and infestations
Osteomyelitis
|
3.6%
2/55
|
0.00%
0/58
|
|
Infections and infestations
Pelvic Abscess
|
3.6%
2/55
|
1.7%
1/58
|
|
Infections and infestations
Perianal Abscess
|
1.8%
1/55
|
0.00%
0/58
|
|
Infections and infestations
Pneumonia
|
12.7%
7/55
|
0.00%
0/58
|
|
Infections and infestations
Postoperative Wound Infection
|
1.8%
1/55
|
3.4%
2/58
|
|
Infections and infestations
Pyelonephritis
|
1.8%
1/55
|
0.00%
0/58
|
|
Infections and infestations
Sepsis
|
1.8%
1/55
|
3.4%
2/58
|
|
Infections and infestations
Urinary Tract Infection
|
5.5%
3/55
|
0.00%
0/58
|
|
Infections and infestations
Urosepsis
|
3.6%
2/55
|
0.00%
0/58
|
|
Infections and infestations
Wound Infection
|
3.6%
2/55
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/55
|
1.7%
1/58
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.8%
1/55
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complications
|
12.7%
7/55
|
1.7%
1/58
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
5.5%
3/55
|
10.3%
6/58
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
1.8%
1/55
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Open Wound
|
0.00%
0/55
|
1.7%
1/58
|
Other adverse events
| Measure |
Strattice Fascial Inlay
n=55 participants at risk
Strattice placed as a fascial inlay to support the ostomy site
|
Standard Ostomy Construction
n=58 participants at risk
Ostomy created in the standard fashion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
32.7%
18/55
|
17.2%
10/58
|
|
Cardiac disorders
Tachycardia
|
12.7%
7/55
|
15.5%
9/58
|
|
Gastrointestinal disorders
Abdominal Distension
|
23.6%
13/55
|
15.5%
9/58
|
|
General disorders
Asthenia
|
7.3%
4/55
|
8.6%
5/58
|
|
Infections and infestations
Abdominal Abscess
|
1.8%
1/55
|
5.2%
3/58
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.9%
6/55
|
5.2%
3/58
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.5%
3/55
|
6.9%
4/58
|
|
Gastrointestinal disorders
Abdominal Pain
|
36.4%
20/55
|
37.9%
22/58
|
|
Gastrointestinal disorders
Constipation
|
7.3%
4/55
|
13.8%
8/58
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
3/55
|
15.5%
9/58
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
3/55
|
3.4%
2/58
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
2/55
|
5.2%
3/58
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/55
|
5.2%
3/58
|
|
Gastrointestinal disorders
Ileus
|
10.9%
6/55
|
6.9%
4/58
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
9.1%
5/55
|
3.4%
2/58
|
|
Gastrointestinal disorders
Nausea
|
52.7%
29/55
|
51.7%
30/58
|
|
Gastrointestinal disorders
Proctalgia
|
9.1%
5/55
|
8.6%
5/58
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
7.3%
4/55
|
12.1%
7/58
|
|
Gastrointestinal disorders
Vomiting
|
38.2%
21/55
|
34.5%
20/58
|
|
General disorders
Chest Pain
|
5.5%
3/55
|
5.2%
3/58
|
|
General disorders
Fatigue
|
16.4%
9/55
|
25.9%
15/58
|
|
General disorders
Oedema Peripheral
|
5.5%
3/55
|
5.2%
3/58
|
|
General disorders
Pyrexia
|
23.6%
13/55
|
17.2%
10/58
|
|
Infections and infestations
Cellulitis
|
5.5%
3/55
|
6.9%
4/58
|
|
Infections and infestations
Pneumonia
|
7.3%
4/55
|
5.2%
3/58
|
|
Infections and infestations
Postoperative Wound Infection
|
5.5%
3/55
|
6.9%
4/58
|
|
Infections and infestations
Sepsis
|
1.8%
1/55
|
5.2%
3/58
|
|
Infections and infestations
Urinary Tract Infection
|
23.6%
13/55
|
22.4%
13/58
|
|
Infections and infestations
Urosepsis
|
5.5%
3/55
|
0.00%
0/58
|
|
Infections and infestations
Wound Infection
|
5.5%
3/55
|
3.4%
2/58
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complications
|
32.7%
18/55
|
36.2%
21/58
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
9.1%
5/55
|
1.7%
1/58
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
14.5%
8/55
|
12.1%
7/58
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
5.5%
3/55
|
8.6%
5/58
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
23.6%
13/55
|
20.7%
12/58
|
|
Investigations
Abnormal Breathing
|
0.00%
0/55
|
5.2%
3/58
|
|
Investigations
Oxygen Saturation Decreased
|
1.8%
1/55
|
8.6%
5/58
|
|
Investigations
Urine Output Decreased
|
9.1%
5/55
|
5.2%
3/58
|
|
Metabolism and nutrition disorders
Anorexia
|
7.3%
4/55
|
1.7%
1/58
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.5%
3/55
|
3.4%
2/58
|
|
Metabolism and nutrition disorders
Dehydration
|
14.5%
8/55
|
22.4%
13/58
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.8%
1/55
|
6.9%
4/58
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.3%
4/55
|
6.9%
4/58
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.9%
6/55
|
8.6%
5/58
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.3%
4/55
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
3/55
|
6.9%
4/58
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.3%
4/55
|
8.6%
5/58
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.8%
1/55
|
6.9%
4/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.5%
3/55
|
3.4%
2/58
|
|
Nervous system disorders
Dizziness
|
9.1%
5/55
|
12.1%
7/58
|
|
Nervous system disorders
Headache
|
9.1%
5/55
|
3.4%
2/58
|
|
Psychiatric disorders
Anxiety
|
3.6%
2/55
|
5.2%
3/58
|
|
Psychiatric disorders
Confused State
|
1.8%
1/55
|
8.6%
5/58
|
|
Psychiatric disorders
Depression
|
9.1%
5/55
|
5.2%
3/58
|
|
Psychiatric disorders
Insomnia
|
7.3%
4/55
|
6.9%
4/58
|
|
Renal and urinary disorders
Haematuria
|
3.6%
2/55
|
10.3%
6/58
|
|
Renal and urinary disorders
Acute Renal Failure
|
7.3%
4/55
|
6.9%
4/58
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.8%
1/55
|
5.2%
3/58
|
|
Renal and urinary disorders
Urinary Retention
|
5.5%
3/55
|
6.9%
4/58
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.5%
3/55
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
5/55
|
5.2%
3/58
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.5%
3/55
|
6.9%
4/58
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
5.5%
3/55
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.5%
3/55
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/55
|
5.2%
3/58
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/55
|
5.2%
3/58
|
|
Surgical and medical procedures
Incisional Drainage
|
7.3%
4/55
|
3.4%
2/58
|
|
Vascular disorders
Hypertension
|
7.3%
4/55
|
3.4%
2/58
|
|
Vascular disorders
Hypotension
|
25.5%
14/55
|
10.3%
6/58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60