Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
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.
Miscellaneous
Phase IV
Adults
Not Available
Not Available
Pierce, Richard
International
Vanderbilt University
06-09-2020
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
1. Must be 18 years of age
1. Must be 18 years of age
2. Elective, open midline laparotomy 5 cm
2. Elective, open midline laparotomy 5 cm
3. Willing and able to provide written informed consent
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater
4. Hernia risk equal to moderate or greater
Exclusion Criteria:
1. Previous hernia repair
1. Previous hernia repair
2. Emergent surgery
2. Emergent surgery
3. Creation of skin flaps is preplanned
3. Creation of skin flaps is preplanned
4. Preplanned 2nd surgery
4. Preplanned 2nd surgery
5. Active skin pathology
5. Active skin pathology
6. Life expectancy less than 36 months
6. Life expectancy less than 36 months
7. Pregnant or planning to become pregnant
7. Pregnant or planning to become pregnant
8. Receiving a medication/medical condition that may adversely affect wound healing
8. Receiving a medication/medical condition that may adversely affect wound healing
9. ASA Class > IV
9. ASA Class > IV
10. Enrolled in another clinical trial
10. Enrolled in another clinical trial
11. Site personnel directly involved with this 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
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
13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
14. Two separate incisions are created
14. Two separate incisions are created
15. Prior onlay mesh
15. Prior onlay mesh
16. Surgeon is unable to fully close the fascia
16. Surgeon is unable to fully close the fascia
17. The surgery requires more than a single piece of mesh
17. The surgery requires more than a single piece of mesh
18. Contraindication to placement of mesh
18. Contraindication to placement of mesh
19. CDC Class IV/Active Infection
19. CDC Class IV/Active Infection
20. Breastfeeding
20. Breastfeeding
1. Must be 18 years of age
1. Must be 18 years of age
2. Elective, open midline laparotomy 5 cm
2. Elective, open midline laparotomy 5 cm
3. Willing and able to provide written informed consent
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater
4. Hernia risk equal to moderate or greater
Exclusion Criteria:
1. Previous hernia repair
1. Previous hernia repair
2. Emergent surgery
2. Emergent surgery
3. Creation of skin flaps is preplanned
3. Creation of skin flaps is preplanned
4. Preplanned 2nd surgery
4. Preplanned 2nd surgery
5. Active skin pathology
5. Active skin pathology
6. Life expectancy less than 36 months
6. Life expectancy less than 36 months
7. Pregnant or planning to become pregnant
7. Pregnant or planning to become pregnant
8. Receiving a medication/medical condition that may adversely affect wound healing
8. Receiving a medication/medical condition that may adversely affect wound healing
9. ASA Class > IV
9. ASA Class > IV
10. Enrolled in another clinical trial
10. Enrolled in another clinical trial
11. Site personnel directly involved with this 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
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
13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
14. Two separate incisions are created
14. Two separate incisions are created
15. Prior onlay mesh
15. Prior onlay mesh
16. Surgeon is unable to fully close the fascia
16. Surgeon is unable to fully close the fascia
17. The surgery requires more than a single piece of mesh
17. The surgery requires more than a single piece of mesh
18. Contraindication to placement of mesh
18. Contraindication to placement of mesh
19. CDC Class IV/Active Infection
19. CDC Class IV/Active Infection
20. Breastfeeding
20. Breastfeeding
