Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 3M | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Emergent abdominal surgeries have very high rate of wound contamination due to exposure to bacteria from GI tract. There are several different approaches to wound management in these patients including wet-to-dry dressing or application vacuum assisted device on the wound. The investigators propose using the vacuum assisted device with Dakin's solution on patients undergoing emergency surgery for hollow viscus perforation installed immediately at the end of operation and remained there for the first 3 postoperative days, followed by delayed primary closure on postoperative day 4. The investigators believe this technique can achieve earlier wound closure, decrease patient discomfort, improve cost savings, and potentially standardize and revolutionize the investigators management of heavily contaminated wounds.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Veraflo" device, Dakin's solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Veraflo" device, Dakin's solution | Device | Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Surgical Site Infection | Surgical site infection is defined as the presence of localized inflammatory signs such as hyperthermia, erythema, tenderness, or purulent discharge that results in positive cultures, along with positive wound cultures. Surgical site can also be regarded as infected based on the individual discretion of the treating physician. Surgical sites with >10^5 colonization in swab will be considered contaminated. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wong-Baker Faces Pain Rating Scale | The Wong-Baker Faces Pain Rating scale is used to grade pain related to the presence/manipulation of the device. The Wong-Baker scale range is from 0 (No Hurt) to 10 (Hurts Worst) with numbers increasing by 2 (0, 2, 4, 6, 8, 10) and associated face images showing increased pain and sadness. Higher scores indicate increased pain, a worse outcome. | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew M Tang, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Medical Center | Tucson | Arizona | 85724 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | "Veraflo" Device, Dakin's Solution | "Veraflo" device, Dakin's solution: Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | "Veraflo" Device, Dakin's Solution | "Veraflo" device, Dakin's solution: Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Surgical Site Infection | Surgical site infection is defined as the presence of localized inflammatory signs such as hyperthermia, erythema, tenderness, or purulent discharge that results in positive cultures, along with positive wound cultures. Surgical site can also be regarded as infected based on the individual discretion of the treating physician. Surgical sites with >10^5 colonization in swab will be considered contaminated. | Posted | Count of Participants | Participants | 2 weeks |
|
Through hospital discharge (approx. 2 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "Veraflo" Device, Dakin's Solution | "Veraflo" device, Dakin's solution: Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals. |
Not provided
Not provided
Limited sample size as a result of difficulty in consenting subjects prior to trauma surgery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Tang, MD | University of Arizona | 520-626-5056 | traumaresearch@arizona.edu |
Not provided
| 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 14, 2017 | Dec 11, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smokers | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Wong-Baker Faces Pain Rating Scale | The Wong-Baker Faces Pain Rating scale is used to grade pain related to the presence/manipulation of the device. The Wong-Baker scale range is from 0 (No Hurt) to 10 (Hurts Worst) with numbers increasing by 2 (0, 2, 4, 6, 8, 10) and associated face images showing increased pain and sadness. Higher scores indicate increased pain, a worse outcome. | Posted | Mean | Full Range | pain score | 1 week |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
Not provided
Not provided
Not provided