Complicated Diverticulitis, Gastrointestinal Injury
Conditions
Brief summary
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.
Interventions
DEVICEVeraflo 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.
Sponsors
3M
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergent surgery involving hollow viscus perforation or necrotic bowel * Admitted to the University of Arizona Medical Center, Tucson, AZ
Exclusion criteria
* Prisoners * Pregnancy * Patients with allergy to Dakin's (sodium hypochlorite) solution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Surgical Site Infection | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker Faces Pain Rating Scale | 1 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Veraflo Device, Dakin's Solution |
|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 17.2 |
| BMI | 28.6 kg/m^2 STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 10 Participants |
| Smokers | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Veraflo Device, Dakin's Solution | Rate of Surgical Site Infection | 5 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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Veraflo Device, Dakin's Solution | Wong-Baker Faces Pain Rating Scale | 6 pain score |