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Site decided not to continue
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The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy versus a highly absorbent antimicrobial post - operative absorbent dressing.
A healing complication is defined as presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure), drainage form the wound after 96 hours post operatively.
The secondary objectives are to assess any changes in the following assessments of the surgical incision weekly over the treatment period:
Assessment of the following at dressing changes:
To assess the overall comparison of Avance® Solo to the standard of care foam dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Negative pressure to the incision site and managing exudate generated by the incision. |
|
| Optifoam | Active Comparator | This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avance Solo | Device | Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Healing Complication | Healing complications are defined as the presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Skin Necrosis Complications | Incisional complication as assessed by number of skin necrosis complications | 90 days |
| Number of Cellulitis Complications | Incisional complication as assessed by number of cellulitis complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C Lantis, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lauren Rodio | New York | New York | 10019 | United States |
All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
Anyone who wishes to access the data. Any purpose. Proposals should be directed to john.lantis@mountsinai.org. To gain access, data requestors will need to sign a data access agreement.
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Recruitment began 6/1/22, with first enrollment on 7/12/22. Recruitment continued until study was terminated on 5/1/23.
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Pressure Wound Therapy | Negative pressure to the incision site and managing exudate generated by the incision. Avance Solo: Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision. |
| FG001 | Optifoam | This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Pressure Wound Therapy | Negative pressure to the incision site and managing exudate generated by the incision. Avance Solo: Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Healing Complication | Healing complications are defined as the presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure) | Data not collected. Study terminated before endpoint data collection. | Posted | 21 days |
|
Two weeks.
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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 Wound Therapy | Negative pressure to the incision site and managing exudate generated by the incision. Avance Solo: Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excessive serosanguinoius fluid secretion | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John C Lantis II | Icahn School of Medicine at Mount Sinai | (212) 523-4797 | John.Lantis@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2022 | Feb 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009767 | Obesity, Morbid |
| D008209 | Lymphedema |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Optifoam | Other | Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds. |
|
| 90 days |
| Number of Abscess Complications | Incisional complication as assessed by number of abscess complications | 90 days |
| Number of Suture Abscess Complications | Incisional complication as assessed by number of suture abscess complications | 90 days |
| Number of Seroma Complications | Incisional complication as assessed by number of seroma complications | 90 days |
| Number of Periwound Edema Complications | Incisional complication as assessed by number of periwound edema complications | 90 days |
| Number of Hematoma Complications | Incisional complication as assessed by number of hematoma complications | 90 days |
| Pain During Dressing Changes | Patient reported as none, mild, moderate, or severe | 90 days |
| Patient Satisfaction | Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction | 90 days |
| Active arm terminated; trial was ended. |
|
| Optifoam |
This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds. |
|
| Secondary | Number of Skin Necrosis Complications | Incisional complication as assessed by number of skin necrosis complications | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Number of Cellulitis Complications | Incisional complication as assessed by number of cellulitis complications | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Number of Abscess Complications | Incisional complication as assessed by number of abscess complications | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Number of Suture Abscess Complications | Incisional complication as assessed by number of suture abscess complications | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Number of Seroma Complications | Incisional complication as assessed by number of seroma complications | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Number of Periwound Edema Complications | Incisional complication as assessed by number of periwound edema complications | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Number of Hematoma Complications | Incisional complication as assessed by number of hematoma complications | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Pain During Dressing Changes | Patient reported as none, mild, moderate, or severe | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| Secondary | Patient Satisfaction | Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction | Data not collected. Study terminated before endpoint data collection. | Posted | 90 days |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Optifoam | This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds. | 0 | 8 | 0 | 8 | 0 | 8 |
| Excessive bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |