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Lack of staff resources to properly consent and enroll patients into the study.
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Incisional negative pressure therapy (INPWT) has previously been shown in certain patient populations to decrease wound healing complications, decrease the rate of hematomas and seromas, as well as have better scar quality. We have found a group of patients, those who have panniculectomies in preparation for renal transplant, with significantly higher rates of wound healing complications. We believe the best way to demonstrate benefits of incisional negative pressure wound therapy will be in this group of patients known to have significantly higher rates of wound complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Closure | Placebo Comparator | After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive). |
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| Incisional Negative Pressure Wound Therapy | Active Comparator | After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisional Negative Pressure Wound Therapy | Procedure |
| ||
| Standard Closure with Skin Glue |
| Measure | Description | Time Frame |
|---|---|---|
| Major Wound Healing Complications | Abscess, Hematoma or any wound complication requiring return to the operating room. | Up to 3 months after operation |
| Minor Wound Healing Complications | Cellulitis, Seroma, Superficial Wound Separation | Up to 3 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Drain Removal | Time to final drain removal after the operation | Up to 3 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Scarring | Will assess using Vancouver Scar Scale | data not collected due to early termination |
| Pain Score Self Reported by the Patient After Surgery | Assess via a visual analog scale at specified intervals |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Wong, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Closure | After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive). Standard Closure with Skin Glue Dermabond: Final wound closure with skin glue. |
| FG001 | Incisional Negative Pressure Wound Therapy |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2015 |
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| Procedure |
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| PICO (Smith&Nephew) | Device | Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister. |
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| Dermabond | Device | Final wound closure with skin glue. |
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| data not collected due to early termination |
| Quality of Life as Measured by SF-36 Validated Survey | Assess via SF-36 validated survey at specified intervals | data not collected due to early termination |
After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion. Incisional Negative Pressure Wound Therapy PICO (Smith&Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Closure | After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive). Standard Closure with Skin Glue Dermabond: Final wound closure with skin glue. |
| BG001 | Incisional Negative Pressure Wound Therapy | After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion. Incisional Negative Pressure Wound Therapy PICO (Smith&Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Wound Healing Complications | Abscess, Hematoma or any wound complication requiring return to the operating room. | Posted | Count of Participants | Participants | Up to 3 months after operation |
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| Primary | Minor Wound Healing Complications | Cellulitis, Seroma, Superficial Wound Separation | Posted | Count of Participants | Participants | Up to 3 months after operation |
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| Secondary | Time to Drain Removal | Time to final drain removal after the operation | Posted | Mean | Standard Deviation | days | Up to 3 months after operation |
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| Other Pre-specified | Scarring | Will assess using Vancouver Scar Scale | Not Posted | data not collected due to early termination | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pain Score Self Reported by the Patient After Surgery | Assess via a visual analog scale at specified intervals | Unable to perform final analysis due to early closure of the study | Posted | data not collected due to early termination |
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| Other Pre-specified | Quality of Life as Measured by SF-36 Validated Survey | Assess via SF-36 validated survey at specified intervals | unable to perform final analysis due to early termination of study | Posted | data not collected due to early termination |
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6 months period following panniculectomy surgery
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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 Closure | After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive). Standard Closure with Skin Glue Dermabond: Final wound closure with skin glue. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Incisional Negative Pressure Wound Therapy | After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion. Incisional Negative Pressure Wound Therapy PICO (Smith&Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yunfeng Xue | UC Davis Medical Center | 408-603-0507 | yunxue@ucdavis.edu |
| Mar 25, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2019 | Mar 25, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D009765 | Obesity |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Participants |
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| Participants |
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