Brief Summary
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
Brief Title
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Detailed Description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
401-209-7141
Central Contact Email
amanda.resendes@bd.com
Central Contact Role
Contact
Central Contact Phone
404-327-1221
Central Contact Email
jaime.ritter@bd.com
Completion Date
Completion Date Type
Estimated
Conditions
Open Midline Laparotomy
Eligibility Criteria
Inclusion Criteria:
1. Must be ≥ 18 years of age
2. Elective, open midline laparotomy ≥ 5 cm
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater
Exclusion Criteria:
1. Previous hernia repair
2. Emergent surgery
3. Creation of skin flaps is preplanned
4. Preplanned 2nd surgery
5. Active skin pathology
6. Life expectancy less than 36 months
7. Pregnant or planning to become pregnant
8. Receiving a medication/medical condition that may adversely affect wound healing
9. ASA Class \> IV
10. Enrolled in another clinical trial
11. Site personnel directly involved with this trial
12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
14. Two separate incisions are created
15. Prior onlay mesh
16. Surgeon is unable to fully close the fascia
17. The surgery requires more than a single piece of mesh
18. Contraindication to placement of mesh
19. CDC Class IV/Active Infection
20. Breastfeeding
1. Must be ≥ 18 years of age
2. Elective, open midline laparotomy ≥ 5 cm
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater
Exclusion Criteria:
1. Previous hernia repair
2. Emergent surgery
3. Creation of skin flaps is preplanned
4. Preplanned 2nd surgery
5. Active skin pathology
6. Life expectancy less than 36 months
7. Pregnant or planning to become pregnant
8. Receiving a medication/medical condition that may adversely affect wound healing
9. ASA Class \> IV
10. Enrolled in another clinical trial
11. Site personnel directly involved with this trial
12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
14. Two separate incisions are created
15. Prior onlay mesh
16. Surgeon is unable to fully close the fascia
17. The surgery requires more than a single piece of mesh
18. Contraindication to placement of mesh
19. CDC Class IV/Active Infection
20. Breastfeeding
Inclusion Criteria
Inclusion Criteria:
1. Must be ≥ 18 years of age
2. Elective, open midline laparotomy ≥ 5 cm
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater
1. Must be ≥ 18 years of age
2. Elective, open midline laparotomy ≥ 5 cm
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03911700
Org Class
Industry
Org Full Name
C. R. Bard
Org Study Id
DVL-HE-018
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
Primary Outcomes
Outcome Description
The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)
Outcome Measure
Rate of Incisional Hernia
Outcome Time Frame
36-Months
Secondary Outcomes
Outcome Description
Rate of incisional hernia at each follow up time point
Outcome Time Frame
60-Months
Outcome Measure
Rate of Incisional Hernia
Outcome Description
Rate of Device-related Adverse Events (AEs)
Outcome Time Frame
60-Months
Outcome Measure
Rate of Device-related Adverse Events (AEs)
Outcome Description
Length of surgical procedure in minutes
Outcome Time Frame
Study Day 0
Outcome Measure
Length of surgical procedure in minutes
Outcome Description
Length of time for wound closure in minutes
Outcome Time Frame
Study Day 0
Outcome Measure
Length of time for wound closure in minutes
Outcome Description
Length of hospital stay in days
Outcome Time Frame
Through hospital stay, typically 3 days
Outcome Measure
Length of hospital stay in days
Outcome Description
Health-related quality of life will be measured using the Optum SF-12v2. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores from the subject's perspective (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better quality of life.
Outcome Time Frame
60-Months
Outcome Measure
Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®)
Outcome Description
EuroQoL-Five Dimensions questionnaire-using Three Levels EQ-5D-3L is a standardized instrument for measuring generic health status. It consists of two components; health status description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves visual analogue scale, asking the subject to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
Outcome Time Frame
60-months
Outcome Measure
Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Erin Moran-Atkin
Investigator Email
emorana@montefiore.org