An interventional study of "Veraflo" device, Dakin's solution in Gastrointestinal Injury and Complicated Diverticulitis, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 18 is below the median of 120 across 63 interventional studies indexed under Diverticulitis.
Browse Diverticulitis studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
Device: "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.
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.
Time frame: 2 weeks
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.
Time frame: 1 week
| Milestone | "Veraflo" Device, Dakin's Solution |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
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.
| Participants | "Veraflo" Device, Dakin's Solution |
|---|---|
| Rate of Surgical Site Infection | 5 |
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.
| pain score | "Veraflo" Device, Dakin's Solution |
|---|---|
| Wong-Baker Faces Pain Rating Scale | 6 (4 to 6) |
Collected over Through hospital discharge (approx. 2 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| "Veraflo" Device, Dakin's Solution | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | "Veraflo" Device, Dakin's Solution |
|---|---|
| Mean | 62.7 ± 17.2 |
| Sex: Female, Male(Participants) | "Veraflo" Device, Dakin's Solution |
|---|---|
| Female | 8 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | "Veraflo" Device, Dakin's Solution |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| BMI(kg/m^2) | "Veraflo" Device, Dakin's Solution |
|---|---|
| Mean | 28.6 ± 5.8 |
| Smokers(Participants) | "Veraflo" Device, Dakin's Solution |
|---|---|
| Count of participants | 7 |
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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