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The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as compared to SOC dressing, and to significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC surgical incision dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | dry sterile dressing/gauze and steristrips |
|
| Customizable | Experimental | Prevena Customizable Dressing with ActiV.A.C. Therapy Unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customizable Dressing with ActiV.A.C. Therapy Unit | Device |
| ||
| Standard of Care Dressing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Surgical Site Complications | Surgical Site Complications:
| Within 30 Days Post-Surgical Procedure |
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Pre-Operative Inclusion Criteria:
an adult 18 years old or older of either gender
able to provide their own informed consent
will undergo:
a functional panniculectomy with a transverse or a fleur-de-lis incision
an incisional hernia repair with a vertical incision at least 20 cm in length and at least 10 cm of undermining on each side of the incision
BMI equal to or greater than 30
has maintained a stable weight for at least 3 months as determined by the Investigator (applies to post weight loss patients only)
pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:
Class I (Clean): An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital or uninfected urinary tract is not entered
Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital or uninfected urinary tract are entered under controlled conditions and without unusual contamination
willing and able to return for all scheduled study visits
if a female of child-bearing potential, must test negative on a urine pregnancy test
if a female of child-bearing potential, must be willing to utilize an acceptable method of birth control (i.e. oral contraceptives, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch) for the duration of the study
Intra-Operative Inclusion Criteria:
Pre-Operative Exclusion Criteria:
has a systemic bacterial or fungal infection at the time of surgery for incisional hernia repair and/or functional panniculectomy
has a remote-site skin infection at the time of surgery for incisional hernia repair or functional panniculectomy
pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:
Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
will have a transverse or fleur-de-lis incision that extends beyond the flank area and requires moving the Subject from the supine position during surgery
has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
has participated in a clinical study within the past 30 days
who, in the investigator's opinion, would have any clinically significant condition that would impair the Subject's ability to comply with the study procedures
Post-Operative Exclusion Criteria:
found to meet any of the pre-operative exclusion criteria
determined to have a CDC Wound Classification of:
Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Center | Miami | Florida | 33144 | United States | ||
| University of Pittsburgh Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | dry sterile dressing/gauze and steristrips |
| FG001 | Customizable | Customizable Dressing with ActiV.A.C. Therapy Unit |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2016 | Jun 20, 2018 |
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| Device |
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | dry sterile dressing/gauze and steristrips Standard of Care Dressing |
| BG001 | Customizable | Customizable Dressing with ActiV.A.C. Therapy Unit Customizable Dressing with ActiV.A.C. Therapy Unit |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Surgical Site Complications | Surgical Site Complications:
| Intent to Treat population | Posted | Count of Participants | Participants | Within 30 Days Post-Surgical Procedure |
|
|
|
|
30 days
Adverse Events were assessed at each protocol scheduled visit. The safety population had one subject less than the ITT population as they were randomized to Standard of Care yet a received Customizable dressing. The Customizable dressing was applied without any negative pressure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | dry sterile dressing/gauze and steristrips Standard of Care Dressing | 0 | 34 | 0 | 34 | 2 | 34 |
| EG001 | Customizable | Customizable Dressing with ActiV.A.C. Therapy Unit Customizable Dressing with ActiV.A.C. Therapy Unit | 0 | 36 | 2 | 36 | 7 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
The study was terminated after an interim data review as the SSC rates were outside the ranges of the sample size assumptions used for the study design.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Director, Global Clinical Development | Acelity | 2102555595 | jane.hart@acelity.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2017 | Jun 20, 2018 | SAP_001.pdf |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|