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Inguinal Hernia Study Using Biodesign IHM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393887
Recruitment Status : Completed
First Posted : October 29, 2006
Results First Posted : August 25, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
Cook Biotech Incorporated
MED Institute, Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Inguinal Hernia
Interventions Device: Biodesign IHM
Device: Polypropylene mesh
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Biodesign IHM Graft Polypropylene Mesh
Hide Arm/Group Description Biodesign Inguinal Hernia Matrix (IHM) Synthetic polypropylene mesh
Period Title: Overall Study
Started 50 50
1 Year 45 50
Completed 34 41
Not Completed 16 9
Reason Not Completed
Physician Decision             5             0
Lost to Follow-up             11             9
Arm/Group Title Biodesign IHM Graft Polypropylene Mesh Total
Hide Arm/Group Description Biodesign Inguinal Hernia Matrix (IHM) Synthetic polypropylene mesh Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
64
(24 to 85)
59
(25 to 87)
61.5
(24 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
50
 100.0%
50
 100.0%
100
 100.0%
1.Primary Outcome
Title Number of Patients With Inguinal Hernia Recurrence
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biodesign IHM Graft Polypropylene Mesh
Hide Arm/Group Description:
Inguinal hernia repair with Biodesign Inguinal Hernia Matrix (IHM)
Inguinal hernia repair with Polypropylene mesh
Overall Number of Participants Analyzed 45 50
Measure Type: Number
Unit of Measure: participants
3 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Biodesign IHM Graft, Polypropylene Mesh
Comments Two-sided Fisher's exact test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Biodesign IHM Graft Polypropylene Mesh
Hide Arm/Group Description Biodesign Inguinal Hernia Matrix (IHM) Synthetic polypropylene mesh
All-Cause Mortality
Biodesign IHM Graft Polypropylene Mesh
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Biodesign IHM Graft Polypropylene Mesh
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/45 (15.56%)      5/50 (10.00%)    
Cardiac disorders     
MI resulting in death  [1]  1/45 (2.22%)  1 0/50 (0.00%)  0
Bradycardia during hernia repair  [1]  1/45 (2.22%)  1 0/50 (0.00%)  0
General disorders     
Motorcycle accident resulting in death  [1]  0/45 (0.00%)  0 1/50 (2.00%)  1
Infections and infestations     
Right inguinal pain, inflammation, and tenderness  [2]  1/45 (2.22%)  1 0/50 (0.00%)  0
Left groin pain and scrotal swelling  [2]  1/45 (2.22%)  1 0/50 (0.00%)  0
Diverticulitis and prostatitis requiring hospitalization  [1]  0/45 (0.00%)  0 1/50 (2.00%)  1
Injury, poisoning and procedural complications     
Substantial bleeding with central-line placement  [1]  0/45 (0.00%)  0 1/50 (2.00%)  1
Renal and urinary disorders     
Urinary tract infection (UTI) requiring hospitalization  [1]  1/45 (2.22%)  1 0/50 (0.00%)  0
Urinary retention requiring overnight observation  [1]  0/45 (0.00%)  0 1/50 (2.00%)  1
Surgical and medical procedures     
Severe pain requiring hospitalization  [1]  0/45 (0.00%)  0 1/50 (2.00%)  1
Vascular disorders     
Hematoma requiring hospitalization  [1]  1/45 (2.22%)  1 0/50 (0.00%)  0
Scrotal hematoma requiring hospitalization  [1]  1/45 (2.22%)  1 0/50 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
unrelated to the device
[2]
Requiring hospitalization - possibly related to the device
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Biodesign IHM Graft Polypropylene Mesh
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/45 (40.00%)      15/50 (30.00%)    
Injury, poisoning and procedural complications     
Postoperative pain   2/45 (4.44%)  2 3/50 (6.00%)  3
Nervous system disorders     
Neuralgia   4/45 (8.89%)  4 6/50 (12.00%)  6
Renal and urinary disorders     
Testicular problems   5/45 (11.11%)  5 4/50 (8.00%)  4
Urinary retention   6/45 (13.33%)  6 3/50 (6.00%)  3
Surgical and medical procedures     
Hematoma   6/45 (13.33%)  6 1/50 (2.00%)  1
Seroma   5/45 (11.11%)  5 0/50 (0.00%)  0
Incisional pain   2/45 (4.44%)  2 4/50 (8.00%)  4
Surgical site reaction   3/45 (6.67%)  3 0/50 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jason Hodde, Clinical Affairs Manager
Organization: Cook Biotech Incorporated
Phone: 765-497-3355
EMail: jhodde@cookbiotech.com
Layout table for additonal information
Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00393887    
Other Study ID Numbers: H-28044
05-003
First Submitted: October 26, 2006
First Posted: October 29, 2006
Results First Submitted: July 29, 2015
Results First Posted: August 25, 2015
Last Update Posted: November 20, 2015