Trial Outcomes & Findings for Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias (NCT NCT02691962)
NCT ID: NCT02691962
Last Updated: 2021-10-21
Results Overview
Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Up to 45 days post implantation
Results posted on
2021-10-21
Participant Flow
Participant milestones
| Measure |
Subjects Treated With Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
Baseline characteristics by cohort
| Measure |
Subjects Treated With XenMatrix AB
n=75 Participants
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 45 days post implantationPopulation: The primary endpoint was wound occurrence within 45 days post implantation that required intervention.
Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Outcome measures
| Measure |
Xen Matrix AB
n=75 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Number of Participants With Wound Occurrences Up to 45 Days Post Implantation
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 45 and up to 2 years post implantationWound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Outcome measures
| Measure |
Xen Matrix AB
n=75 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Number of Participants With Wound Occurrences > 45 Days Post Implantation
|
15 Participants
|
SECONDARY outcome
Timeframe: Within 6 months and 24 months of implantation procedureOutcome measures
| Measure |
Xen Matrix AB
n=75 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
Within 6 Months
|
0 Participants
|
|
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
Within 24 Months
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 months post implantation procedureOutcome measures
| Measure |
Xen Matrix AB
n=75 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Number of Participants With Reoperation Due to Index Hernia Repair
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
The Carolinas Comfort Scale (CCS) quality of life questionnaire aimed for patients who have had hernia repair surgery. Symptoms in the CCS are rated by the participants on a scale of 0 to 5, with a score of 0 suggesting no symptoms and a score of 5, disabling symptoms. A lower score on the questionnaire compared to baseline would indicate a better outcome.
Outcome measures
| Measure |
Xen Matrix AB
n=75 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
Baseline
|
1.6 Score on a scale
Standard Deviation 1.65
|
|
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
1 month
|
1.4 Score on a scale
Standard Deviation 1.42
|
|
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
3 months
|
1.2 Score on a scale
Standard Deviation 1.37
|
|
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
6 months
|
0.9 Score on a scale
Standard Deviation 1.18
|
|
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
12 months
|
0.8 Score on a scale
Standard Deviation 1.06
|
|
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
18 months
|
0.8 Score on a scale
Standard Deviation 1.15
|
|
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
24 months
|
0.6 Score on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, 6, 12, 18, and 24 months post implantationPopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
The Short Form 12 (SF-12) is a self-reported 12-item questionnaire that evaluates general health and well-being (overall quality of life of an individual). The SF-12 includes questions on physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating better levels of functioning.
Outcome measures
| Measure |
Xen Matrix AB
n=75 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
Baseline
|
47.7 score on a scale
Standard Deviation 11.14
|
|
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
1 month
|
47.2 score on a scale
Standard Deviation 10.30
|
|
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
3 months
|
48.6 score on a scale
Standard Deviation 10.28
|
|
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
6 months
|
48.3 score on a scale
Standard Deviation 9.77
|
|
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
12 months
|
48.3 score on a scale
Standard Deviation 11.06
|
|
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
18 months
|
49.4 score on a scale
Standard Deviation 9.17
|
|
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
24 months
|
47.9 score on a scale
Standard Deviation 9.49
|
SECONDARY outcome
Timeframe: Up to 2 years following implantation procedurePopulation: The overall number of participants (21) for this endpoint reflects the number of participants who were employed at baseline.
Outcome measures
| Measure |
Xen Matrix AB
n=21 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Number of Participants Who Returned to Work Post Implantation Procedure
|
17 Participants
|
SECONDARY outcome
Timeframe: From index procedure day to discharge from hospital dayOutcome measures
| Measure |
Xen Matrix AB
n=75 Participants
Subjects treated with Xen Matrix AB
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Duration of Participants Stay in Hospital Following Implantation Procedure
|
6.7 Days
Standard Deviation 6.13
|
Adverse Events
Subjects Treated With Xen Matrix AB
Serious events: 31 serious events
Other events: 55 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Subjects Treated With Xen Matrix AB
n=75 participants at risk
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Gastrointestinal disorders
Abdominal hernia
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Gastrointestinal disorders
Ileus
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.7%
2/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Abdominal abscess
|
4.0%
3/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Abdominal wall abscess
|
9.3%
7/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Bacteraemia
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Diverticulitis
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Haematoma infection
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Incision site infection
|
2.7%
2/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Necrotising fasciitis
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Postoperative wound infection
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
4.0%
3/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Seroma
|
12.0%
9/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Renal and urinary disorders
Calculus ureteric
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Renal and urinary disorders
Ureteric obstruction
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Skin lesion
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
1/75 • From Day of index procedure up to 24 months post implantation procedure.
|
Other adverse events
| Measure |
Subjects Treated With Xen Matrix AB
n=75 participants at risk
This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
6/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
4/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Abdominal wall abscess
|
9.3%
7/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Incision site cellulitis
|
6.7%
5/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Infections and infestations
Incision site infection
|
5.3%
4/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
8.0%
6/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
5.3%
4/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Iatronic injury
|
5.3%
4/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
5.3%
4/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
5.3%
4/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.0%
9/75 • From Day of index procedure up to 24 months post implantation procedure.
|
|
Injury, poisoning and procedural complications
Seroma
|
20.0%
15/75 • From Day of index procedure up to 24 months post implantation procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The publication of the principal results from any single-center experience within the study is not allowed until the preparation and publication of the multi-center results.
- Publication restrictions are in place
Restriction type: OTHER