Trial Outcomes & Findings for Strattice in Repair of Inguinal Hernias (NCT NCT00681291)

Results Overview

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty = 1" to "Not able to do it = 5." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

172 participants

Primary outcome timeframe

Baseline to 3 Months

Results posted on

2016-05-10

Participant Flow

First subject was enrolled on April 11, 2008 and last subject was enrolled on February 12, 2010.

Participant milestones

Participant milestones
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) Strattice
Overall Study STARTED	88	84
Overall Study COMPLETED	75	57
Overall Study NOT COMPLETED	13	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Strattice in Repair of Inguinal Hernias

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n=88 Participants lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) n=84 Participants Strattice	Total n=172 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 13.78 • n=5 Participants	55.2 years STANDARD_DEVIATION 14.53 • n=7 Participants	55.8 years STANDARD_DEVIATION 14.12 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	84 Participants n=7 Participants	172 Participants n=5 Participants
Region of Enrollment United States	88 participants n=5 Participants	84 participants n=7 Participants	172 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 Months

Population: Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months.

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty = 1" to "Not able to do it = 5." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.

Outcome measures

Outcome measures
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n=81 Participants lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) n=77 Participants Strattice
Change From Baseline in Activities Assessment Scale at 3 Months	-7.49 units on a scale Standard Deviation 8.961	-6.12 units on a scale Standard Deviation 8.666

PRIMARY outcome

Timeframe: Baseline to 6 Months

Population: Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months.

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.

Outcome measures

Outcome measures
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n=83 Participants lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) n=70 Participants Strattice
Change From Baseline in Activities Assessment Scale at 6 Months	-8.17 units on a scale Standard Deviation 9.475	-7.20 units on a scale Standard Deviation 8.818

PRIMARY outcome

Timeframe: Baseline to 12 Months

Population: Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months.

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.

Outcome measures

Outcome measures
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n=83 Participants lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) n=70 Participants Strattice
Change From Baseline in Activities Assessment Scale at 12 Months	-8.78 units on a scale Standard Deviation 9.221	-7.61 units on a scale Standard Deviation 9.059

PRIMARY outcome

Timeframe: Baseline to 24 Months

Population: Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months.

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.

Outcome measures

Outcome measures
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n=75 Participants lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) n=57 Participants Strattice
Change From Baseline in Activities Assessment Scale at 24 Months	-7.57 units on a scale Standard Deviation 8.098	-7.53 units on a scale Standard Deviation 9.356

Adverse Events

1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

2Strattice (Utilized for Inguinal Hernia Repair)

Serious events: 4 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n=88 participants at risk lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) n=84 participants at risk Strattice
Gastrointestinal disorders Inguinal Hernia	2.3% 2/88 • Number of events 2	4.8% 4/84 • Number of events 4

Other adverse events

Other adverse events
Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n=88 participants at risk lightweight polypropylene mesh	2Strattice (Utilized for Inguinal Hernia Repair) n=84 participants at risk Strattice
Gastrointestinal disorders Inguinal Hernia	3.4% 3/88 • Number of events 3	7.1% 6/84 • Number of events 6
General disorders Local Swelling	5.7% 5/88 • Number of events 5	2.4% 2/84 • Number of events 2
Injury, poisoning and procedural complications Incision Site Pain	5.7% 5/88 • Number of events 5	8.3% 7/84 • Number of events 7
Investigations C-Reactive Protein Increased	17.0% 15/88 • Number of events 15	25.0% 21/84 • Number of events 21
Musculoskeletal and connective tissue disorders Groin Pain	13.6% 12/88 • Number of events 12	4.8% 4/84 • Number of events 4
Nervous system disorders Hypoaethesia	2.3% 2/88 • Number of events 2	9.5% 8/84 • Number of events 8
Reproductive system and breast disorders Testicular Pain	5.7% 5/88 • Number of events 5	1.2% 1/84 • Number of events 1

Additional Information

Donna Jacobs

LifeCell

Phone: 908-809-7856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Should Institution/PI/coPI/other staff want to publish information, data, or orally communicate,a complete copy of information/data will be provided to the Sponsor for review and comment at least 30 days prior to 1st submission. If Sponsor determines proposed publication/oral communication contains patentable or proprietary subject matter (requiring protection),Institution will delay for at least 90 days following the Sponsor's receipt of such copy for the purpose of filing patent applications.
Publication restrictions are in place

Restriction type: OTHER