Trial Outcomes & Findings for Inguinal Hernia Study Using Biodesign IHM (NCT NCT00393887)
NCT ID: NCT00393887
Last Updated: 2015-11-20
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
1 year
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
Biodesign IHM Graft
Biodesign Inguinal Hernia Matrix (IHM)
|
Polypropylene Mesh
Synthetic polypropylene mesh
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
1 Year
|
45
|
50
|
|
Overall Study
COMPLETED
|
34
|
41
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
Reasons for withdrawal
| Measure |
Biodesign IHM Graft
Biodesign Inguinal Hernia Matrix (IHM)
|
Polypropylene Mesh
Synthetic polypropylene mesh
|
|---|---|---|
|
Overall Study
Physician Decision
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
9
|
Baseline Characteristics
Inguinal Hernia Study Using Biodesign IHM
Baseline characteristics by cohort
| Measure |
Biodesign IHM Graft
n=50 Participants
Biodesign Inguinal Hernia Matrix (IHM)
|
Polypropylene Mesh
n=50 Participants
Synthetic polypropylene mesh
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
59 years
n=4 Participants
|
61.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Biodesign IHM Graft
n=45 Participants
Inguinal hernia repair with Biodesign Inguinal Hernia Matrix (IHM)
|
Polypropylene Mesh
n=50 Participants
Inguinal hernia repair with Polypropylene mesh
|
|---|---|---|
|
Number of Patients With Inguinal Hernia Recurrence
|
3 participants
|
0 participants
|
Adverse Events
Biodesign IHM Graft
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Polypropylene Mesh
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biodesign IHM Graft
n=45 participants at risk
Biodesign Inguinal Hernia Matrix (IHM)
|
Polypropylene Mesh
n=50 participants at risk
Synthetic polypropylene mesh
|
|---|---|---|
|
Vascular disorders
Hematoma requiring hospitalization
|
2.2%
1/45 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Renal and urinary disorders
Urinary tract infection (UTI) requiring hospitalization
|
2.2%
1/45 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
MI resulting in death
|
2.2%
1/45 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Scrotal hematoma requiring hospitalization
|
2.2%
1/45 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Bradycardia during hernia repair
|
2.2%
1/45 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Infections and infestations
Right inguinal pain, inflammation, and tenderness
|
2.2%
1/45 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Infections and infestations
Left groin pain and scrotal swelling
|
2.2%
1/45 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Infections and infestations
Diverticulitis and prostatitis requiring hospitalization
|
0.00%
0/45 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Substantial bleeding with central-line placement
|
0.00%
0/45 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Motorcycle accident resulting in death
|
0.00%
0/45 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Severe pain requiring hospitalization
|
0.00%
0/45 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary retention requiring overnight observation
|
0.00%
0/45 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Biodesign IHM Graft
n=45 participants at risk
Biodesign Inguinal Hernia Matrix (IHM)
|
Polypropylene Mesh
n=50 participants at risk
Synthetic polypropylene mesh
|
|---|---|---|
|
Injury, poisoning and procedural complications
Postoperative pain
|
4.4%
2/45 • Number of events 2 • 12 months
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Hematoma
|
13.3%
6/45 • Number of events 6 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Seroma
|
11.1%
5/45 • Number of events 5 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Neuralgia
|
8.9%
4/45 • Number of events 4 • 12 months
|
12.0%
6/50 • Number of events 6 • 12 months
|
|
Renal and urinary disorders
Testicular problems
|
11.1%
5/45 • Number of events 5 • 12 months
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
Renal and urinary disorders
Urinary retention
|
13.3%
6/45 • Number of events 6 • 12 months
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Incisional pain
|
4.4%
2/45 • Number of events 2 • 12 months
|
8.0%
4/50 • Number of events 4 • 12 months
|
|
Surgical and medical procedures
Surgical site reaction
|
6.7%
3/45 • Number of events 3 • 12 months
|
0.00%
0/50 • 12 months
|
Additional Information
Jason Hodde, Clinical Affairs Manager
Cook Biotech Incorporated
Phone: 765-497-3355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60