Trial Outcomes & Findings for A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft (NCT NCT01205399)
NCT ID: NCT01205399
Last Updated: 2017-01-18
Results Overview
A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.
Recruitment status
COMPLETED
Target enrollment
78 participants
Primary outcome timeframe
9 + Months
Results posted on
2017-01-18
Participant Flow
From September 2010 through October 2011 a total of 78 subjects were enrolled at 4 study centers in the United States. The fifth site was terminated because subject data could not be source verified.
Participant milestones
| Measure |
AlloMax Surgical Graft Group
The study group included eligible subjects who underwent hernia repair using the AlloMax™ Surgical Graft at least 9 months prior to the start of this study.
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
Baseline characteristics by cohort
| Measure |
AlloMax Surgical Graft Group
n=78 Participants
|
|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
|
Gender
Female
|
43 Participants
n=5 Participants
|
|
Gender
Male
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
|
Body Mass Index
|
36.7 kilograms per square meter
STANDARD_DEVIATION 9.92 • n=5 Participants
|
PRIMARY outcome
Timeframe: 9 + MonthsPopulation: All enrolled subjects that could be verified through historical medical record review.
A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.
Outcome measures
| Measure |
AlloMax Surgical Graft Group
n=78 Participants
|
|---|---|
|
Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft
|
17 participants
|
SECONDARY outcome
Timeframe: 9+ MonthsPopulation: All enrolled subjects that could be verified through historical medical record review.
Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit.
Outcome measures
| Measure |
AlloMax Surgical Graft Group
n=78 Participants
|
|---|---|
|
Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.
|
166 complication events
|
SECONDARY outcome
Timeframe: 0 DaysPopulation: All enrolled subjects that could be verified through historical medical record review.
Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).
Outcome measures
| Measure |
AlloMax Surgical Graft Group
n=78 Participants
|
|---|---|
|
Procedural Time for AlloMax Surgical Graft Placement.
|
161.8 minutes
Standard Deviation 58.45
|
Adverse Events
AlloMax Surgical Graft Group
Serious events: 50 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AlloMax Surgical Graft Group
n=78 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/78 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
3/78 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
5.1%
4/78 • Number of events 4
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.6%
2/78 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.6%
2/78 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/78 • Number of events 1
|
|
General disorders
Fatigue
|
1.3%
1/78 • Number of events 1
|
|
General disorders
Impaired healing
|
2.6%
2/78 • Number of events 2
|
|
Infections and infestations
Abdominal abscess
|
3.8%
3/78 • Number of events 3
|
|
Infections and infestations
Abdominal infection
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Abdominal wall abscess
|
6.4%
5/78 • Number of events 5
|
|
Infections and infestations
Bacteraemia
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
3.8%
3/78 • Number of events 3
|
|
Infections and infestations
Clostridial infection
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Groin infection
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Wound infection
|
5.1%
4/78 • Number of events 4
|
|
Infections and infestations
Wound infection staphylococcal
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
15.4%
12/78 • Number of events 12
|
|
Injury, poisoning and procedural complications
Open wound
|
3.8%
3/78 • Number of events 3
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
3.8%
3/78 • Number of events 3
|
|
Injury, poisoning and procedural complications
Seroma
|
19.2%
15/78 • Number of events 16
|
|
Injury, poisoning and procedural complications
Suture related complication
|
1.3%
1/78 • Number of events 2
|
|
Investigations
Culture wound positive
|
1.3%
1/78 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
1.3%
1/78 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
1/78 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
2.6%
2/78 • Number of events 2
|
|
Reproductive system and breast disorders
Cystocele
|
1.3%
1/78 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
1.3%
1/78 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/78 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
1.3%
1/78 • Number of events 1
|
|
Surgical and medical procedures
Caesaren section
|
1.3%
1/78 • Number of events 1
|
|
Vascular disorders
Haematoma
|
3.8%
3/78 • Number of events 3
|
Other adverse events
| Measure |
AlloMax Surgical Graft Group
n=78 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/78 • Number of events 1
|
|
Congenital, familial and genetic disorders
Epidermolysis
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
2/78 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
2/78 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
20.5%
16/78 • Number of events 17
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.6%
2/78 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Gastric polyps
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
15.4%
12/78 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
15.4%
12/78 • Number of events 13
|
|
Gastrointestinal disorders
Peritonitis
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.3%
1/78 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
4/78 • Number of events 4
|
|
General disorders
Pyrexia
|
1.3%
1/78 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cyst
|
1.3%
1/78 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Abdominal wall abscess
|
2.6%
2/78 • Number of events 2
|
|
Infections and infestations
Body tinea
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
7.7%
6/78 • Number of events 6
|
|
Infections and infestations
Postoperative wound infection
|
2.6%
2/78 • Number of events 2
|
|
Infections and infestations
Sepsis
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.6%
2/78 • Number of events 2
|
|
Infections and infestations
Wound infection
|
3.8%
3/78 • Number of events 3
|
|
Infections and infestations
Wound infection staphylococcal
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
9.0%
7/78 • Number of events 7
|
|
Injury, poisoning and procedural complications
Open wound
|
2.6%
2/78 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
2.6%
2/78 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
3.8%
3/78 • Number of events 3
|
|
Injury, poisoning and procedural complications
Seroma
|
12.8%
10/78 • Number of events 10
|
|
Investigations
Blood culture positive
|
1.3%
1/78 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
3.8%
3/78 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
1.3%
1/78 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
2.6%
2/78 • Number of events 2
|
|
Renal and urinary disorders
Hydronephrosis
|
1.3%
1/78 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.3%
1/78 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/78 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
1/78 • Number of events 1
|
|
Renal and urinary disorders
Stress urinary incontinence
|
1.3%
1/78 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
2/78 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.6%
2/78 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scar
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.3%
1/78 • Number of events 1
|
|
Vascular disorders
Haematoma
|
1.3%
1/78 • Number of events 1
|
|
Vascular disorders
Lymphoedema
|
1.3%
1/78 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.3%
1/78 • Number of events 1
|
Additional Information
Dawn Heimer/Director, Clinical Affairs
C. R. Bard: Davol, Inc.
Phone: 401-825-8681
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60