Trial Outcomes & Findings for Feasibility of Permacol Use in Infected Fields (NCT NCT00820040)

NCT ID: NCT00820040

Last Updated: 2020-12-09

Results Overview

The primary objective of this study was hernia recurrence or surgical site infection as assessed by a CT scan 12 months following surgery.Hernia recurrence was defined as any abnormal abdominal protrusion, as assessed by 12 month CT. Surgical site infection requiring wound opening was defined as abscess formation or drainage that required surgical wound opening. Wound opening was defined as surgical entry into the wound.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

12 months

Results posted on

2020-12-09

Participant Flow

Subjects diagnosed with infected prosthetic mesh who were scheduled to undergo planned removal of the mesh were assessed for potential study eligibility. Subjects needed to fulfill all inclusion criteria and no exclusion criteria to be enrolled into the study.

One subject was considered a screen failure due to undergoing chemotherapy for an active malignancy within a year prior to the screening visit.

Participant milestones

Participant milestones
Measure	Permacol acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Overall Study STARTED	10
Overall Study Safety Evaluable Population	8
Overall Study Full Analysis Set	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Permacol acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Overall Study Death	1
Overall Study Sponsor terminated study	1
Overall Study Screen failure	1

Baseline Characteristics

Feasibility of Permacol Use in Infected Fields

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Permacol n=8 Participants acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Age, Continuous	58.0 years STANDARD_DEVIATION 13.35 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	8 participants n=93 Participants
Weight	253.1 lb STANDARD_DEVIATION 55.92 • n=93 Participants
Height	70.0 inches STANDARD_DEVIATION 5.58 • n=93 Participants
BMI	36.91 kg/m² STANDARD_DEVIATION 7.812 • n=93 Participants
Employment Status Disability/Sick Leave	4 participants n=93 Participants
Employment Status Full Time	2 participants n=93 Participants
Employment Status Missing	2 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Hernia recurrence and Surgical Site Infection Requiring Wound Opening for one subject could not be assessed due to death unrelated to the study device. The subject died 19 days post-operatively and therefore primary endpoints assessed at 12 month visit were reported as missing.

Outcome measures

Outcome measures
Measure	Permacol n=8 Participants acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening No Hernia Recurrence or Surgical Site Infection Requiring Wound Opening	7 Participants
Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening Missing	1 Participants

SECONDARY outcome

Timeframe: 12 months

The secondary objective of this study was the incidence of Permacol™ surgical implant removal or debridement. Removal was defined as complete surgical excision of the implant. Debridement was defined as debridement or lavage of ≥10% of the visible implant surface area as subjectively assessed by the operating surgeon.

Outcome measures

Outcome measures
Measure	Permacol n=8 Participants acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Subjects Having Permacol Implants Removed or Debrided After Implantation None Reported	8 Participants
Subjects Having Permacol Implants Removed or Debrided After Implantation Reported	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-month post-procedure change from baseline

Population: At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.

The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment.

Outcome measures

Outcome measures
Measure	Permacol n=7 Participants acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Physical and Other Examinations Physical Functioning	12.37 score on a scale Standard Deviation 16.292
Physical and Other Examinations Role Physical	10.28 score on a scale Standard Deviation 7.271
Physical and Other Examinations Bodily Pain	7.73 score on a scale Standard Deviation 14.194
Physical and Other Examinations General Health	-0.57 score on a scale Standard Deviation 6.953
Physical and Other Examinations Social Functioning	8.90 score on a scale Standard Deviation 10.270
Physical and Other Examinations Role Emotional	11.14 score on a scale Standard Deviation 16.000
Physical and Other Examinations Vitality	2.81 score on a scale Standard Deviation 14.715
Physical and Other Examinations Mental Health	4.92 score on a scale Standard Deviation 9.027
Physical and Other Examinations Physical Component Score	7.96 score on a scale Standard Deviation 10.167
Physical and Other Examinations Mental Component Score	5.42 score on a scale Standard Deviation 8.769

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.

Outcome measures

Outcome measures
Measure	Permacol n=8 Participants acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Physical and Other Examinations Physical Functioning	37.39 score on a scale Standard Deviation 10.304
Physical and Other Examinations Role Physical	37.36 score on a scale Standard Deviation 7.417
Physical and Other Examinations Bodily Pain	39.69 score on a scale Standard Deviation 12.754
Physical and Other Examinations General Health	44.52 score on a scale Standard Deviation 13.225
Physical and Other Examinations Social Functioning	41.34 score on a scale Standard Deviation 12.352
Physical and Other Examinations Role Emotional	35.49 score on a scale Standard Deviation 14.437
Physical and Other Examinations Vitality	47.84 score on a scale Standard Deviation 11.075
Physical and Other Examinations Mental Health	46.28 score on a scale Standard Deviation 10.814
Physical and Other Examinations Physical Component Score	39.18 score on a scale Standard Deviation 8.947
Physical and Other Examinations Mental Component Score	44.61 score on a scale Standard Deviation 9.849

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-month post-procedure

Population: At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.

Outcome measures

Outcome measures
Measure	Permacol n=7 Participants acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Physical and Other Examinations Physical Functioning	49.19 score on a scale Standard Deviation 11.130
Physical and Other Examinations Role Physical	47.19 score on a scale Standard Deviation 12.422
Physical and Other Examinations Bodily Pain	47.42 score on a scale Standard Deviation 12.134
Physical and Other Examinations General Health	45.48 score on a scale Standard Deviation 12.223
Physical and Other Examinations Social Functioning	50.55 score on a scale Standard Deviation 9.895
Physical and Other Examinations Role Emotional	46.63 score on a scale Standard Deviation 16.00
Physical and Other Examinations Vitality	50.47 score on a scale Standard Deviation 10.514
Physical and Other Examinations Mental Health	51.92 score on a scale Standard Deviation 12.581
Physical and Other Examinations Physical Component Score	46.96 score on a scale Standard Deviation 7.822
Physical and Other Examinations Mental Component Score	50.58 score on a scale Standard Deviation 12.289

Adverse Events

Permacol

Serious events: 4 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Permacol n=8 participants at risk acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Skin and subcutaneous tissue disorders Skin Rash	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Cardiac disorders Tachycardia	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Cardiac disorders Cardiopulmonary Failure	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Reproductive system and breast disorders Left epididymal orchitis with scrotal edema	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.

Other adverse events

Other adverse events
Measure	Permacol n=8 participants at risk acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Blood and lymphatic system disorders Anemia	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Cardiac disorders Atrial fibrillation	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Cardiac disorders Tachycardia	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Metabolism and nutrition disorders Dehydration	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Gastrointestinal disorders Abdominal tenderness	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Gastrointestinal disorders Oropharyngeal blistering	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
General disorders Adverse drug reaction	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
General disorders Oedema peripheral	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
General disorders Pyrexia	25.0% 2/8 • Number of events 2 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Infections and infestations Abdominal abscess	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Infections and infestations Onychomycosis	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Infections and infestations Staphylococcal infection	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Injury, poisoning and procedural complications Incision site pain	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Injury, poisoning and procedural complications Postoperative ileus	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Investigations Blood pressure decreased	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Metabolism and nutrition disorders Decreased appetite	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Metabolism and nutrition disorders Hypokalaemia	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Metabolism and nutrition disorders Hypomagnesaemia	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Metabolism and nutrition disorders Hypophosphataemia	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Nervous system disorders Incontinence	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Nervous system disorders Urinary incontinence	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Psychiatric disorders Agitation	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Psychiatric disorders Delirium	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Renal and urinary disorders Dysuria	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Renal and urinary disorders Renal failure acute	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Renal and urinary disorders Urinary tract infection	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	25.0% 2/8 • Number of events 2 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Skin and subcutaneous tissue disorders Ichthyosis	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Vascular disorders Hypertension	12.5% 1/8 • Number of events 1 • 12-months All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.

Additional Information

Heather McManus

Medtronic

Phone: 2038213323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place