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Enrollment challenges and business reasons.
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) | Experimental | V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution |
|
| Collagenase Ointment | Active Comparator | Collagenase Ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Therapy w/ instillation and dwell (NPWTi-d) | Device | Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal. | The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal. | baseline and 6-9 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal. | baseline and 6-9 days of treatment |
| Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. |
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Inclusion Criteria:
The Subject:
is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
is ≥ 18 years of age.
or their legally authorized representative is able to provide informed consent.
has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria:
has, in the opinion of the investigator, no more than 2/3 of the wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).
Exclusion Criteria:
The Subject:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner-University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| University of Arizona |
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days. |
| FG001 |
| 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 | Feb 13, 2020 | May 22, 2023 |
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|
| Collagenase Ointment | Biological | Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days. |
|
The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal. |
| baseline and 6-9 days of treatment |
| Physician Assessment of Need for Wound Debridement | Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9. | 6-9 days of treatment |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| South Shore Hospital Center for Wound Healing | Weymouth | Massachusetts | 02190 | United States |
| University of Missouri | Columbia | Missouri | 65211 | United States |
| Northwell Health System - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| New York University - Winthrop Hospital | Mineola | New York | 11501 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Collagenase Ointment |
Collagenase Ointment Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days. |
| COMPLETED |
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| NOT COMPLETED |
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This is the modified intent-to-treat (ITT) population, which is a subset of all subjects randomized who had no more than 2/3 of the wound bed considered to be clean, healthy, and viable, as well as had an end-point assessment on day 6-9.
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days. |
| BG001 | Collagenase Ointment | Collagenase Ointment Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days. |
| 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 |
| ||||||||||||||||
| Wound Type | Count of Participants | 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 | Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal. | The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal. | Modified ITT population | Posted | Mean | Standard Deviation | percent wound clean healthy viable. | baseline and 6-9 days of treatment |
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| Secondary | Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal. | Modified ITT population | Posted | Mean | Standard Deviation | percent change in wound volume | baseline and 6-9 days of treatment |
|
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| Secondary | Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal. | Modified ITT population | Posted | Mean | Standard Deviation | percent change in wound area | baseline and 6-9 days of treatment |
|
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| Secondary | Physician Assessment of Need for Wound Debridement | Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9. | Modified ITT population | Posted | Count of Participants | Participants | 6-9 days of treatment |
|
|
Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
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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 | Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days. | 0 | 17 | 2 | 17 | 8 | 17 |
| EG001 | Collagenase Ointment | Collagenase Ointment Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days. | 0 | 25 | 2 | 25 | 15 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| impaired healing | General disorders | Systematic Assessment |
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| sepsis | Infections and infestations | Systematic Assessment |
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| post-procedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fluid overload | Cardiac disorders | Systematic Assessment |
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| gastro-intestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| pyrexia | General disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| blood potassium increase | Investigations | Systematic Assessment |
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| hemoglobin decrease | Investigations | Systematic Assessment |
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| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| hypotension | Vascular disorders | Systematic Assessment |
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| splenic infarction | Blood and lymphatic system disorders | Systematic Assessment |
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| atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| conjunctivitis | Eye disorders | Systematic Assessment |
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| dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| epi-gastric discomfort | Gastrointestinal disorders | Systematic Assessment |
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| flatulence | Gastrointestinal disorders | Systematic Assessment |
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| lethargy | General disorders | Systematic Assessment |
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| mucosal hypertrophy | General disorders | Systematic Assessment |
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| pain | General disorders | Systematic Assessment |
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| candida infection | Infections and infestations | Systematic Assessment |
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| osteomyelitis | Infections and infestations | Systematic Assessment |
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| wound infection | Infections and infestations | Systematic Assessment |
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| blood glucose decreased | Investigations | Systematic Assessment |
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| white blood cell count increased | Investigations | Systematic Assessment |
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| hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hyper natremia | Metabolism and nutrition disorders | Systematic Assessment |
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| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| device occlusion | Product Issues | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
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| incontinence | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sher-ree Beekman | 3M | 262-409-5112 | sbeekman@mmm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2022 | May 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D017364 | Collagenases |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
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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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| Venous leg ulcer |
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| Other |
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