Trial Outcomes & Findings for Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair (NCT NCT05610267)

Results Overview

Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

90 days

Results posted on

2024-06-18

Participant Flow

The retrospective chart review including the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and September 1, 2022 (90 days prior to the start of data collection) started in November 2022 and ended in december 2022. The enrollment occured at a single Surgical center.

29 subjects screened, 1 subject, screened failure. 28 subjects, male and female were enrolled and completed the study.

Participant milestones

Participant milestones
Measure	Device: Retrospective Chart Review Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a hernia with Integra Gentrix® Surgical Matrix.
Age, Continuous	58.4 years STANDARD_DEVIATION 12.24 • n=99 Participants
Sex: Female, Male Female	16 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	21 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants
Region of Enrollment United States	28 participants n=99 Participants

PRIMARY outcome

Timeframe: 90 days

Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure	2 Participants

SECONDARY outcome

Timeframe: 90 days

Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure	8 Participants

SECONDARY outcome

Timeframe: 90 days

Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Incidence of Surgical Site Infections (SSIs) Post Index Procedure	4 Participants

SECONDARY outcome

Timeframe: 1 year

Percentage of subjects with a later post-operative complications after 90 days post index procedure

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Incidence of Later Post-operative Complications After 90 Days Post Index Procedure	4 Participants

SECONDARY outcome

Timeframe: 1 year

Percentage of subjects with a hernia recurrence confirmed by clinical assessment

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Incidence of Hernia Recurrence Confirmed by Clinical Assessment	1 Participants

SECONDARY outcome

Timeframe: 1 year

Percentage of subjects with a reoperation requirement due to index repair

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Incidence of Reoperation Requirement Due to Index Repair	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Number of days between the date of the index procedure and the date of the hospital discharge

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days)	2.8 Days Standard Deviation 2.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Number of subjects who used opioids following the procedure based on the concomitants medication

Outcome measures

Outcome measures
Measure	Device: Retrospective Chart Review n=28 Participants Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled	24 Participants

Adverse Events

Device: Retrospective Chart Review

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Device: Retrospective Chart Review n=28 participants at risk Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Gastrointestinal disorders Volvulus of small bowel	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Injury, poisoning and procedural complications Incisional hernia	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Injury, poisoning and procedural complications Postoperative adhesion	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.

Other adverse events

Other adverse events
Measure	Device: Retrospective Chart Review n=28 participants at risk Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix.
Gastrointestinal disorders Intestinal stenosis	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
General disorders Application site haematoma	7.1% 2/28 • Number of events 2 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
General disorders Instillation site haematoma	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Injury, poisoning and procedural complications Abdominal wall abscess	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Infections and infestations Abdominal wall infection	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Infections and infestations Staphylococcal infection	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Infections and infestations Wound infection	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Injury, poisoning and procedural complications Abdominal wound dehiscence	17.9% 5/28 • Number of events 5 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Injury, poisoning and procedural complications Iatrogenic injury	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Injury, poisoning and procedural complications Seroma	14.3% 4/28 • Number of events 4 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.
Surgical and medical procedures Abscess drainage	3.6% 1/28 • Number of events 1 • Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 months.

Additional Information

Dr. Dennis Adam Young

Integra LifeSciences

Phone: 443 766 2569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place