Trial Outcomes & Findings for A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair (NCT NCT02053168)

Results Overview

A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months

Results posted on

2018-05-11

Participant Flow

Of 33 subjects enrolled, 8 were not treated with the study device: a contraindication to the placement of mesh was present in 4 subjects; complete removal of existing mesh from a prior hernia repair (in the same affected area) was not possible in 3 subjects; and 1 subject had an active or latent systemic infection.

Participant milestones

Participant milestones
Measure	Resorbable Mesh Phasix Mesh Resorbable Mesh: Phasix Mesh
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Resorbable Mesh Phasix Mesh Resorbable Mesh: Phasix Mesh
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Age, Continuous	55.2 years STANDARD_DEVIATION 17.12 • n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	25 participants n=93 Participants
Weight	84.3 kg STANDARD_DEVIATION 17.16 • n=93 Participants
Height	166.9 cm STANDARD_DEVIATION 7.53 • n=93 Participants
Body Mass Index	30.3 kg/m^2 STANDARD_DEVIATION 5.81 • n=93 Participants

PRIMARY outcome

Timeframe: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months

A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Number of Participants With Hernia Recurrence 1 Month	0 Participants
Number of Participants With Hernia Recurrence 3 Months	0 Participants
Number of Participants With Hernia Recurrence 6 Months	0 Participants
Number of Participants With Hernia Recurrence 12 Months	1 Participants
Number of Participants With Hernia Recurrence 18 Months	0 Participants
Number of Participants With Hernia Recurrence 24 Months	0 Participants
Number of Participants With Hernia Recurrence >24 Months	1 Participants
Number of Participants With Hernia Recurrence Post Op to End of Study	2 Participants

SECONDARY outcome

Timeframe: 24 Months

In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Number of Participants With Device Related Adverse Events	1 Participants

SECONDARY outcome

Timeframe: Baseline and 24 months postoperative

Population: All participants with non-missing values at both baseline and respective post procedure assessment.

The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=8 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Carolinas Comfort Scale (CCS) Total Score - Change From Baseline	-1.1 units on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: Baseline and 24 months postoperative

Population: All participants with non-missing values at both baseline and respective post procedure assessment.

Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=21 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)	-5.3 units on a scale Standard Deviation 9.98

SECONDARY outcome

Timeframe: Baseline and 24 months postoperative

Population: All participants with non-missing values at both baseline and respective post procedure assessment.

Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=21 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)	-9.4 units on a scale Standard Deviation 9.21

SECONDARY outcome

Timeframe: Duration of index procedure (mean of 242.5 mins)

Measured from incision to closure (skin to skin).

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Surgical Procedure Time	242.5 minutes Standard Deviation 132.2

SECONDARY outcome

Timeframe: 10 Months

Measured from end of index procedure to hospital discharge

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Length of Hospital Stay	5.0 days Standard Deviation 4.04

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Number of Study Related Post Operative Surgical Procedures	7 events

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Number of Study Related Post Operative New Hospital Admissions	5 events

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Number of Related Post-operative Visits Unrelated to Standard of Care	8 events

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	Resorbable Mesh n=25 Participants Phasix Mesh Resorbable Mesh: Phasix Mesh
Incidence of Seroma	1 events

Adverse Events

Resorbable Mesh

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Resorbable Mesh n=25 participants at risk Phasix Mesh Resorbable Mesh: Phasix Mesh
Infections and infestations Superficial surgical site infection	4.0% 1/25 • Number of events 2 • Up to 24 months post index procedure
Injury, poisoning and procedural complications Wound necrosis	4.0% 1/25 • Number of events 2 • Up to 24 months post index procedure
General disorders Seroma	4.0% 1/25 • Number of events 1 • Up to 24 months post index procedure
Gastrointestinal disorders Ileus	8.0% 2/25 • Number of events 2 • Up to 24 months post index procedure
Vascular disorders Hematoma	4.0% 1/25 • Number of events 1 • Up to 24 months post index procedure
Injury, poisoning and procedural complications Stomal hernia	4.0% 1/25 • Number of events 1 • Up to 24 months post index procedure
Cardiac disorders Myocardial hypoxia	4.0% 1/25 • Number of events 1 • Up to 24 months post index procedure
Infections and infestations Abdominal wall wound infection	4.0% 1/25 • Number of events 1 • Up to 24 months post index procedure

Other adverse events

Other adverse events
Measure	Resorbable Mesh n=25 participants at risk Phasix Mesh Resorbable Mesh: Phasix Mesh
Hepatobiliary disorders Cholelithiasis	8.0% 2/25 • Number of events 2 • Up to 24 months post index procedure
Injury, poisoning and procedural complications Incision site pain	8.0% 2/25 • Number of events 2 • Up to 24 months post index procedure
Injury, poisoning and procedural complications Wound dehiscence	8.0% 2/25 • Number of events 2 • Up to 24 months post index procedure

Additional Information

Dawn Heimer

BD Interventional - Surgery

Phone: 401-825-8681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place