Trial Outcomes & Findings for A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair (NCT NCT03450473)
NCT ID: NCT03450473
Last Updated: 2023-02-15
Results Overview
The frequency of hernia recurrence diagnosed by physical exam or CT Scan (if clinically indicated)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
36 Months
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
SurgiMend® MP
Patients will not be randomized as this is a case series study involving the evaluation of only 1 type of mesh (SurgiMend MP®).
SurgiMend® MP: SurgiMend MP® is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. SurgiMend MP® will be used for abdominal wall reinforcement in patients with complex ventral hernia repair.
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair
Baseline characteristics by cohort
| Measure |
SurgiMend® MP
n=20 Participants
Patients will not be randomized as this is a case series study involving the evaluation of only 1 type of mesh (SurgiMend MP®).
SurgiMend® MP: SurgiMend MP® is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. SurgiMend MP® will be used for abdominal wall reinforcement in patients with complex ventral hernia repair.
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|---|---|
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Age, Continuous
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60.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
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Sex: Female, Male
Female
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13 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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15 Participants
n=5 Participants
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Race/Ethnicity, Customized
African American
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5 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 36 MonthsThe frequency of hernia recurrence diagnosed by physical exam or CT Scan (if clinically indicated)
Outcome measures
| Measure |
SurgiMend® MP
n=20 Participants
Patients will not be randomized as this is a case series study involving the evaluation of only 1 type of mesh (SurgiMend MP®).
SurgiMend® MP: SurgiMend MP® is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. SurgiMend MP® will be used for abdominal wall reinforcement in patients with complex ventral hernia repair.
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The Frequency of Hernia Recurrence Diagnosed by Physical Exam or CT Scan (if Clinically Indicated)
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1 Participants
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Adverse Events
SurgiMend® MP
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SurgiMend® MP
n=20 participants at risk
Patients will not be randomized as this is a case series study involving the evaluation of only 1 type of mesh (SurgiMend MP®).
SurgiMend® MP: SurgiMend MP® is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. SurgiMend MP® will be used for abdominal wall reinforcement in patients with complex ventral hernia repair.
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|---|---|
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Surgical and medical procedures
Seroma
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15.0%
3/20 • For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded. The collection of AE's began immediately after the patient had mesh surgically implanted. AEs that occurred from surgery through completion of the final follow-up visit (36 months) were collected.
For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded.
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Other adverse events
| Measure |
SurgiMend® MP
n=20 participants at risk
Patients will not be randomized as this is a case series study involving the evaluation of only 1 type of mesh (SurgiMend MP®).
SurgiMend® MP: SurgiMend MP® is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. SurgiMend MP® will be used for abdominal wall reinforcement in patients with complex ventral hernia repair.
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|---|---|
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Surgical and medical procedures
Post Operative Pain
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5.0%
1/20 • For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded. The collection of AE's began immediately after the patient had mesh surgically implanted. AEs that occurred from surgery through completion of the final follow-up visit (36 months) were collected.
For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded.
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Surgical and medical procedures
Hematoma
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5.0%
1/20 • For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded. The collection of AE's began immediately after the patient had mesh surgically implanted. AEs that occurred from surgery through completion of the final follow-up visit (36 months) were collected.
For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded.
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Surgical and medical procedures
Wound Necrosis
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5.0%
1/20 • For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded. The collection of AE's began immediately after the patient had mesh surgically implanted. AEs that occurred from surgery through completion of the final follow-up visit (36 months) were collected.
For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded.
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Surgical and medical procedures
Hernia Recurrence
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5.0%
1/20 • For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded. The collection of AE's began immediately after the patient had mesh surgically implanted. AEs that occurred from surgery through completion of the final follow-up visit (36 months) were collected.
For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded.
|
|
Surgical and medical procedures
Seroma
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5.0%
1/20 • For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded. The collection of AE's began immediately after the patient had mesh surgically implanted. AEs that occurred from surgery through completion of the final follow-up visit (36 months) were collected.
For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded.
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Surgical and medical procedures
Wound Dehiscence
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5.0%
1/20 • For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded. The collection of AE's began immediately after the patient had mesh surgically implanted. AEs that occurred from surgery through completion of the final follow-up visit (36 months) were collected.
For the purpose of this post-market case series study, only adverse events or serious adverse events that were related to the surgical procedure or device were recorded.
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Additional Information
Dr. Grant Bochicchio
Washington University School of Medicine in St. Louis
Phone: 314-362-9347
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place