Trial Outcomes & Findings for Repair of Infected or Contaminated Hernias (NCT NCT00617357)

NCT ID: NCT00617357

Last Updated: 2015-12-01

Results Overview

Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 83 participants
• Primary outcome timeframe: Postoperatively up to 24 months
• Results posted on: 2015-12-01

Participant Flow

83 subjects enrolled between Sep 2007 and Aug 2008 from 12 US sites and followed for 24 months following hernia repair

83 subjects were enrolled, 3 were not implanted, resulting in 80 subjects implanted with device (ITT group).

Participant milestones

Measure	Strattice Tissue Matrix
Overall Study STARTED	83
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Strattice Tissue Matrix
Overall Study Lost to Follow-up	7
Overall Study Death	5
Overall Study insurance concerns	2
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Repair of Infected or Contaminated Hernias

Baseline characteristics by cohort

Measure	One Arm n=80 Participants Strattice Reconstructive Tissue Matrix
Age, Continuous	57 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	71 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperatively up to 24 months

Population: 80 patients were enrolled and received Strattice Reconstructive Tissue Matrix to support the repair and were included in the Intent to Treat (ITT) population.

Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.

Outcome measures

Measure	One Arm n=80 Participants Strattice Reconstructive Tissue Matrix
Incidence of Wound Events	53 participants

SECONDARY outcome

Timeframe: Baseline

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity.

Outcome measures

Measure	One Arm n=79 Participants Strattice Reconstructive Tissue Matrix
Activities Assessment Scale (AAS)	69.2 units on a scale Standard Deviation 21.45

SECONDARY outcome

Timeframe: 30 Days

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

Outcome measures

Measure	One Arm n=72 Participants Strattice Reconstructive Tissue Matrix
Activities Assessment Scale (AAS)	70.3 units on a scale Standard Deviation 19.47

SECONDARY outcome

Timeframe: 3 Months

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

Outcome measures

Measure	One Arm n=70 Participants Strattice Reconstructive Tissue Matrix
Activities Assessment Scale (AAS)	78.2 units on a scale Standard Deviation 16.06

SECONDARY outcome

Timeframe: 6 Months

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

Outcome measures

Measure	One Arm n=73 Participants Strattice Reconstructive Tissue Matrix
Activities Assessment Scale (AAS)	85.3 units on a scale Standard Deviation 14.17

SECONDARY outcome

Timeframe: 12 Months

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

Outcome measures

Measure	One Arm n=66 Participants Strattice Reconstructive Tissue Matrix
Activities Assessment Scale (AAS)	83.5 units on a scale Standard Deviation 17.10

SECONDARY outcome

Timeframe: 24 Months

The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

Outcome measures

Measure	One Arm n=60 Participants Strattice Reconstructive Tissue Matrix
Activities Assessment Scale (AAS)	82.0 units on a scale Standard Deviation 17.53

Adverse Events

Strattice

Serious events: 50 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Strattice n=80 participants at risk
Gastrointestinal disorders Abdominal Pain	1.2% 1/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Abdominal abscess	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Abdominal wall abscess	2.5% 2/80 • Number of events 3 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Abdominal wound dehiscence	2.5% 2/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Anastomotic leak	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Vascular disorders Arteriosclerosis obliterans	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Ascites	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Cardiac disorders Atrial fibrillation	3.8% 3/80 • Number of events 3 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Bacteraemia	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Cardiac disorders Cardiac arrest	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Catheter site infection	1.2% 1/80 • Number of events 3 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Hepatobiliary disorders Cholecyctitis	2.5% 2/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Hepatobiliary disorders Cholecyctitis chronic	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Investigations Clostridium difficile toxin test positive	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Colostomy infection	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Constipation	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Cardiac disorders Coronary artery disease	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Metabolism and nutrition disorders Dehydration	3.8% 3/80 • Number of events 5 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Psychiatric disorders Delirium	2.5% 2/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Dysphagia	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Folliculitis	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Gastroenteritis	2.5% 2/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Gastrointestinal haemorrhage	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Gastrointestinal stoma complication	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Renal and urinary disorders Haematuria	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Renal and urinary disorders Hydronephrosis	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Metabolism and nutrition disorders Hypokalaemia	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Vascular disorders Hypotension	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Iatrogenic injury	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Ileus	6.2% 5/80 • Number of events 5 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Ileus paralytic	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Incision site haematoma	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Incisional hernia	8.8% 7/80 • Number of events 7 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Intestinal obstruction	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Blood and lymphatic system disorders Leukocytosis	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Metabolism and nutrition disorders Metabolic disorder	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Cardiac disorders Myocardial infarction	2.5% 2/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Osteomyelitis	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Pancreatic fistula	1.2% 1/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Pancreatitis	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Pelvic abscess	2.5% 2/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Vascular disorders Peripheral ischaemia	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Pneumonia	2.5% 2/80 • Number of events 3 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Post procedural fistula	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Postoperative respiratory distress	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Postoperative wound infection	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 3/80 • Number of events 3 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Renal and urinary disorders Renal failure acute	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.2% 1/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Road traffic accident	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Sepsis	2.5% 2/80 • Number of events 2 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Seroma	5.0% 4/80 • Number of events 4 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Small bowel obstruction	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Small intestinal obstruction	3.8% 3/80 • Number of events 6 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Small intestinal stenosis	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Suture related complication	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Urinary tract infection	5.0% 4/80 • Number of events 4 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Gastrointestinal disorders Vomiting	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Wound abscess	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Injury, poisoning and procedural complications Wound complication	1.2% 1/80 • Number of events 1 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)
Infections and infestations Wound infection	11.2% 9/80 • Number of events 11 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)

Other adverse events

Measure	Strattice n=80 participants at risk
Injury, poisoning and procedural complications Seroma	25.0% 20/80 • Number of events 23 The at risk population was comprised of 80 subjects who received Strattice reinforcement of hernia repair (ITT population)

Additional Information

Dr Michael Franz

LifeCell

Phone: 908 947 1100

Email: mfranz@lifecell.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place