Repair of Infected or Contaminated Hernias

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM

Conditions
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Hernia

Intervention / Treatment
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* Device: LTM (Strattice Reconstructive Tissue Matrix)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Strattice Reconstructive Tissue Matrix | Device: LTM (Strattice Reconstructive Tissue Matrix)<br>* Surgical mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperatively up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 30 Days | 
| 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. | 3 Months | 
| 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. | 6 Months | 
| 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. | 12 Months | 
| 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. | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incisional hernia, abdominal hernia repair, Ventral incisional hernia repair