Trial Outcomes & Findings for Tissue Reinforcement of Incisional Closure Among High Risk Patients (NCT NCT03148496)
NCT ID: NCT03148496
Last Updated: 2022-07-22
Results Overview
Proportion of participants with major chronic wound infection
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
1 year after surgery
Results posted on
2022-07-22
Participant Flow
Of the 163 participants enrolled, 107 met inclusion criteria and were randomized
Participant milestones
| Measure |
Biologic Mesh and Small Bites
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
25
|
27
|
|
Overall Study
COMPLETED
|
20
|
19
|
19
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tissue Reinforcement of Incisional Closure Among High Risk Patients
Baseline characteristics by cohort
| Measure |
Biologic Mesh and Small Bites
n=27 Participants
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=28 Participants
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=25 Participants
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=27 Participants
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
25 participants
n=5 Participants
|
27 participants
n=4 Participants
|
107 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 year after surgeryPopulation: Data were not collected for this outcome measure.
Proportion of participants with major chronic wound infection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year after surgeryMajor complications include surgical site infection, ventral incisional hernia, and/or reoperation
Outcome measures
| Measure |
Biologic Mesh and Small Bites
n=27 Participants
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=28 Participants
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=25 Participants
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=27 Participants
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Number of Participants With Major Complications
|
5 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year after surgeryOutcome measures
| Measure |
Biologic Mesh and Small Bites
n=27 Participants
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=28 Participants
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=25 Participants
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=27 Participants
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Number of Participants With Surgical Site Infections
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year after surgeryany unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Outcome measures
| Measure |
Biologic Mesh and Small Bites
n=27 Participants
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=28 Participants
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=25 Participants
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=27 Participants
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Number of Participants With Reoperations
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: about 119 minutes to 337 minuteslength of the entire procedure
Outcome measures
| Measure |
Biologic Mesh and Small Bites
n=27 Participants
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=28 Participants
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=25 Participants
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=27 Participants
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Operative Duration
|
210.19 minutes
Standard Deviation 70.96
|
205.50 minutes
Standard Deviation 70.96
|
230.64 minutes
Standard Deviation 106.48
|
180.26 minutes
Standard Deviation 61.58
|
SECONDARY outcome
Timeframe: 1 year after surgeryPopulation: Data were not collected for 13 participants in the Biologic Mesh arm. Data were not collected for 10 participants in the No Biologic Mesh arm. Data were not collected for 7 participants in the Large Bites arm. Data were not collected for 16 participants in the Small Bites arm.
Quality of life is scored from 1 to 100, where the higher the score the higher quality of life
Outcome measures
| Measure |
Biologic Mesh and Small Bites
n=39 Participants
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=45 Participants
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=45 Participants
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=39 Participants
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Participants Quality of Life as Assessed by Activities Assessment Scale
|
64 score on a scale
Standard Deviation 33
|
70 score on a scale
Standard Deviation 31
|
68 score on a scale
Standard Deviation 32
|
66 score on a scale
Standard Deviation 32
|
SECONDARY outcome
Timeframe: 1 year after surgeryPopulation: Data were not collected for 13 participants in the Biologic Mesh arm. Data were not collected for 10 participants in the No Biologic Mesh arm. Data were not collected for 7 participants in the Large Bites arm. Data were not collected for 16 participants in the Small Bites arm
Health Status is scored from 0 to 100, where the higher the score the better the health
Outcome measures
| Measure |
Biologic Mesh and Small Bites
n=39 Participants
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=45 Participants
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=45 Participants
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=39 Participants
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Participants Health Status as Assessed by the Euroqol-5D Questionnaire
|
80 score on a scale
Interval 60.0 to 100.0
|
80 score on a scale
Interval 60.0 to 100.0
|
80 score on a scale
Interval 55.0 to 100.0
|
80 score on a scale
Interval 70.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 year after surgeryPopulation: Data were not collected for this outcome measure.
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year after surgeryPopulation: Data were not collected for this outcome measure.
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after surgeryPopulation: Data were not collected for this outcome measure.
Major complications include surgical site infection, ventral incisional hernia, and/or reoperation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after surgeryPopulation: Data were not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after surgeryPopulation: Data were not collected for this outcome measure.
any unplanned invasive procedure involving the fascia, mesh, or peritoneal cavity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after surgeryPopulation: Data were not collected for this outcome measure.
Quality of life is scored from 1 to 100, where the higher the score the higher quality of life
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after surgeryPopulation: Data were not collected for this outcome measure.
Health Status is scored from 0 to 100, where the higher the score the better the health
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after surgeryPopulation: Data were not collected for this outcome measure.
calculated from the hospital's perspective by assessing charges for all patient visits, admissions, and procedures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after surgeryPopulation: Data were not collected for this outcome measure.
likert type and open ended questions assessing perception, barriers and likelihood of utilizing interventions outside of the trial
Outcome measures
Outcome data not reported
Adverse Events
Biologic Mesh and Small Bites
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Small Bites and No Biologic Mesh
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Biologic Mesh and Large Bites
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Large Bites and no Biologic Mesh
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biologic Mesh and Small Bites
n=27 participants at risk
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=28 participants at risk
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=25 participants at risk
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=27 participants at risk
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
Surgical and medical procedures
Reoperation
|
7.4%
2/27 • 1 year post surgery
|
3.6%
1/28 • 1 year post surgery
|
8.0%
2/25 • 1 year post surgery
|
7.4%
2/27 • 1 year post surgery
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/27 • 1 year post surgery
|
0.00%
0/28 • 1 year post surgery
|
4.0%
1/25 • 1 year post surgery
|
0.00%
0/27 • 1 year post surgery
|
Other adverse events
| Measure |
Biologic Mesh and Small Bites
n=27 participants at risk
Biologic mesh placement and small bites used for suturing.
Biologic Mesh: Biologic mesh placed during surgery
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Small Bites and No Biologic Mesh
n=28 participants at risk
Small bites used for suturing with no placement of biologic mesh
Small Bites: 0.5 cm x 0.5 cm sutures used
|
Biologic Mesh and Large Bites
n=25 participants at risk
Biologic mesh placement and large bites used for suturing
Biologic Mesh: Biologic mesh placed during surgery
Large Bites: 1.0 x 1.0 sutures used
|
Large Bites and no Biologic Mesh
n=27 participants at risk
Large bites used for suturing and no placement of biologic mesh.
Large Bites: 1.0 x 1.0 sutures used
|
|---|---|---|---|---|
|
General disorders
Ventral incisional hernia
|
7.4%
2/27 • 1 year post surgery
|
14.3%
4/28 • 1 year post surgery
|
16.0%
4/25 • 1 year post surgery
|
7.4%
2/27 • 1 year post surgery
|
|
Infections and infestations
Surgical Site Infection
|
7.4%
2/27 • 1 year post surgery
|
3.6%
1/28 • 1 year post surgery
|
4.0%
1/25 • 1 year post surgery
|
0.00%
0/27 • 1 year post surgery
|
Additional Information
Julie Holihan, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-7188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place