Open Chest Wounds
Conditions
Brief summary
Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.
Interventions
DEVICEWound Vacuum-assisted dressing
The NPWT system (V.A.C. Therapy System, KCI USA Inc.) consisted of a medical-grade non-adherent polyvinyl alcohol white foam applied directly to the infected surface, followed by an open-pore reticulated polyurethane black foam cut to fit the wound and covered by a transparent air-tight adhesive drape. A suction cup with tubing was placed over a small slit on the drape and connected to a suction machine (V.A.C. ULTA Therapy Unit).
OTHERControl group
Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.
Exclusion criteria
* Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation. * Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time. Allergy to acrylic products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Negative Pressure Wound Therapy (NWPT) | 12 month follow up | The total number of days of receiving NWPT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure | 12 months | The total number of days to wound closure |
| Length of Hospital Stay | 12 months | The total number of days in hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Treatment of wound with Vacuum-assisted dressing.
Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing. | 10 |
| Control Group Historical chest wound treatment. | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Control Group | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 62 years | 62 years | 61 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 11 participants | 21 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 10 | 1 / 11 |
| other Total, other adverse events | 2 / 10 | 8 / 11 |
| serious Total, serious adverse events | 2 / 10 | 11 / 11 |
Outcome results
Primary
Duration of Negative Pressure Wound Therapy (NWPT)
The total number of days of receiving NWPT
Time frame: 12 month follow up
Population: Data not collected or analyzed for the Historical Control arm. This arm did not receive the NWPT.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Duration of Negative Pressure Wound Therapy (NWPT) | 8 Days |
Secondary
Length of Hospital Stay
The total number of days in hospital
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Length of Hospital Stay | 6 Days |
| Historical Control | Length of Hospital Stay | 25 Days |
Secondary
Wound Closure
The total number of days to wound closure
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Wound Closure | 7 Days |
| Historical Control | Wound Closure | 18 Days |