Hernia
Conditions
Keywords
incisional hernia, abdominal hernia repair, Ventral incisional hernia repair
Brief summary
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.
Interventions
DEVICELTM (Strattice Reconstructive Tissue Matrix)
Surgical mesh
Sponsors
LifeCell
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* is an adult ≥18 years old. * has need of open abdominal incisional repair of a contaminated or infected site * has an estimated hernia size of \>9cm2 by physical exam
Exclusion criteria
* has a nidus of chronic colonization * has a systemic infection at the time of repair. * has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder. * requires chronic immunosuppressive therapy, including steroids or cytotoxic agents. * is bedridden or otherwise non-ambulatory. * is ASA Class 4 or 5. * has a BMI \>40. * has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Wound Events | Postoperatively up to 24 months | Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities Assessment Scale (AAS) | Baseline | 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 numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity. |
Countries
United States
Participant flow
Recruitment details
83 subjects enrolled between Sep 2007 and Aug 2008 from 12 US sites and followed for 24 months following hernia repair
Pre-assignment details
83 subjects were enrolled, 3 were not implanted, resulting in 80 subjects implanted with device (ITT group).
Participants by arm
| Arm | Count |
|---|---|
| One Arm Strattice Reconstructive Tissue Matrix | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | insurance concerns | 2 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | One Arm |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized Black or African American | 9 participants |
| Race/Ethnicity, Customized Caucasian | 71 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 80 |
| serious Total, serious adverse events | 50 / 80 |
Outcome results
Primary
Incidence of Wound Events
Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.
Time frame: Postoperatively up to 24 months
Population: 80 patients were enrolled and received Strattice Reconstructive Tissue Matrix to support the repair and were included in the Intent to Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| One Arm | Incidence of Wound Events | 53 participants |
Secondary
Activities Assessment Scale (AAS)
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 numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Arm | Activities Assessment Scale (AAS) | 69.2 units on a scale | Standard Deviation 21.45 |
Secondary
Activities Assessment Scale (AAS)
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Arm | Activities Assessment Scale (AAS) | 83.5 units on a scale | Standard Deviation 17.1 |
Secondary
Activities Assessment Scale (AAS)
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.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Arm | Activities Assessment Scale (AAS) | 78.2 units on a scale | Standard Deviation 16.06 |
Secondary
Activities Assessment Scale (AAS)
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Arm | Activities Assessment Scale (AAS) | 85.3 units on a scale | Standard Deviation 14.17 |
Secondary
Activities Assessment Scale (AAS)
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.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Arm | Activities Assessment Scale (AAS) | 82.0 units on a scale | Standard Deviation 17.53 |
Secondary
Activities Assessment Scale (AAS)
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.
Time frame: 30 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One Arm | Activities Assessment Scale (AAS) | 70.3 units on a scale | Standard Deviation 19.47 |