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The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V.A.C.Ulta with Prontosan instillation | Experimental | Treatment Arm |
|
| V.A.C.Ulta without instillation | Active Comparator | Control Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V.A.C.Ulta with Prontosan instillation | Device | NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Inpatient Operating Room Debridements | Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room | until the wound is deemed ready for closure or coverage by the investigator up to 64 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. | Immediately following initial post debridement to the first dressing change up to 72 hours |
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Inclusion Criteria:
The Subject:
Exclusion Criteria:
The Subject:
is pregnant as determined by a positive serum or urine pregnancy test at the time of screening
has a life expectancy of < 12 months
is not healthy enough to undergo surgery for any reason
has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures
has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis)
has rheumatoid arthritis
has a bleeding disorder or coagulopathy
has a wound that contains antibiotic cement or beads
has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of < 0.9 with a history of diabetes, or < 0.6 if the subject is non-diabetic
has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive)
has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer
has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine
has received NPWT on the study wound within the last 30 days
has a wound that is contraindicated with Prontosan
a. presence of hyaline cartilage in the wound
has a wound that is contraindicated with V.A.C. Therapy including:
use of intervening layers between the wound bed and foam
has a wound that is contraindicated with V.A.C. VeraFlo Therapy including:
has a wound that is closed after the initial debridement
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | V.A.C.Ulta With Prontosan Instillation | Treatment Arm V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser |
| FG001 | V.A.C.Ulta Without Instillation | Control Arm V.A.C.Ulta without instillation: NPWT only |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| V.A.C.Ulta without instillation | Device | NPWT only |
|
| University of Miami Miller School of Medicine |
| Miami |
| Florida |
| 33136 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| St. Luke's University Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | V.A.C.Ulta With Prontosan Instillation | Treatment Arm V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser |
| BG001 | V.A.C.Ulta Without Instillation | Control Arm V.A.C.Ulta without instillation: NPWT only |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Inpatient Operating Room Debridements | Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room | Per-protocol population | Posted | Count of Participants | Participants | until the wound is deemed ready for closure or coverage by the investigator up to 64 days |
|
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| Secondary | The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. | Per-protocol population (some subjects had missing assessments) | Posted | Mean | Standard Deviation | Total Bacterial Counts (Log10 CFU) | Immediately following initial post debridement to the first dressing change up to 72 hours |
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| Post-Hoc | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | This only included those patients with wound etiology of Surgically Dehisced Wounds | Posted | Count of Participants | Participants | until the wound is deemed ready for closure or coverage by the investigator up to 64 days |
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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 | V.A.C.Ulta With Prontosan Instillation | Treatment Arm V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser | 3 | 93 | 19 | 93 | 58 | 93 |
| EG001 | V.A.C.Ulta Without Instillation | Control Arm V.A.C.Ulta without instillation: NPWT only | 1 | 88 | 22 | 88 | 44 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MedDRA (13.0) |
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| Wound infection | Infections and infestations | MedDRA (13.0) |
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| Cellulitis | Infections and infestations | MedDRA (13.0) |
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| Sepsis | Infections and infestations | MedDRA (13.0) |
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| Abscess | Infections and infestations | MedDRA (13.0) |
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| Diabetic Foot Infection | Infections and infestations | MedDRA (13.0) |
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| Pneumonia | Infections and infestations | MedDRA (13.0) |
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| Purulent Discharge | Infections and infestations | MedDRA (13.0) |
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| Wound infection Staphylococcal | Infections and infestations | MedDRA (13.0) |
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| Staphylococcal infection | Infections and infestations | MedDRA (13.0) |
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| Wound sepsis | Infections and infestations | MedDRA (13.0) |
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| Transplant Failure | Injury, poisoning and procedural complications | MedDRA (13.0) |
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| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (13.0) |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA (13.0) |
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| Post Porcedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.0) |
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| Failure of Implant | Injury, poisoning and procedural complications | MedDRA (13.0) |
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| Phlebothrombosis | Vascular disorders | MedDRA (13.0) |
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| Wound Haemorrhage | Vascular disorders | MedDRA (13.0) |
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| Ischaemia | Vascular disorders | MedDRA (13.0) |
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| Hypotension | Vascular disorders | MedDRA (13.0) |
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| Peripheral Occlusive Disease | Vascular disorders | MedDRA (13.0) |
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| Haematoma | Vascular disorders | MedDRA (13.0) |
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| Aphasia | Nervous system disorders | MedDRA (13.0) |
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| Encephalopathy | Nervous system disorders | MedDRA (13.0) |
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| Grand Mal Convulsion | Nervous system disorders | MedDRA (13.0) |
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| Major Depression | Psychiatric disorders | MedDRA (13.0) |
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| Mental Status Changes | Psychiatric disorders | MedDRA (13.0) |
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| Aggression | Psychiatric disorders | MedDRA (13.0) |
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| Drug Dependence | Psychiatric disorders | MedDRA (13.0) |
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| Cardiac Arrest | Cardiac disorders | MedDRA (13.0) |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA (13.0) |
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| Myocardial Infarction | Cardiac disorders | MedDRA (13.0) |
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| Peritonitis | Gastrointestinal disorders | MedDRA (13.0) |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) |
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| Enteritis | Gastrointestinal disorders | MedDRA (13.0) |
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| Amputation | Surgical and medical procedures | MedDRA (13.0) |
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| Foot amputation | Surgical and medical procedures | MedDRA (13.0) |
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| Blood Glucose Fluctation | Investigations | MedDRA (13.0) |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA (13.0) |
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| Drug Hypersensitivity | Immune system disorders | MedDRA (13.0) |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) |
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| Skin Graft Failure | Skin and subcutaneous tissue disorders | MedDRA (13.0) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (13.0) |
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| Wound Complication | Injury, poisoning and procedural complications | MedDRA (13.0) |
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| Skin Maceration | Skin and subcutaneous tissue disorders | MedDRA (13.0) |
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| Oedema | General disorders | MedDRA (13.0) |
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| Pain | General disorders | MedDRA (13.0) |
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| Glycosylated Haemoglobin Increased | Investigations | MedDRA (13.0) |
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| White Blood Cell Count Increased | Investigations | MedDRA (13.0) |
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| Constipation | Gastrointestinal disorders | MedDRA (13.0) |
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Prontosan was used for instillation in this study. Approximately ~75% of wounds were not infected. Therefore benefits from a solution with antiseptic properties would be expected to be limited. Acelity is planning to conduct a study using saline.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Tate, RN, BSN | KCI, an Acelity Company | 210-515-4060 | anthony.tate@kci1.com |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 2 debridements |
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| 3 debridements |
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| 4 debridements |
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