Cardiac Surgery
Conditions
Keywords
wound infection, tissue oxygen tension, local warming
Brief summary
Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections
Detailed description
Wound infections are common and serious complications of anesthesia and surgery. The morbidity associated with surgical infections is considerable and includes substantial prolongation of hospitalization. The wound infection risk in patients undergoing cardiac surgery ranges from 0.8 to 17.7% including both superficial and deep sternal infections. Major factors influencing the incidence of surgical wound infection other than site and complexity of surgery, underlying illness, timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia and tissue oxygen tension. The primary determinant of tissue oxygen availability is local perfusion. Thermoregulatory status is one of the major factors influencing tissue perfusion. Local warming induces pre- capillary vasodilation and improves tissue oxygenation. Local warming of surgical wounds may provide a simple and inexpensive way to reduce perioperative wound complications. Specifically, we will test the hypothesis that Warm- Up therapy increases postoperative tissue oxygen tension in patients undergoing cardiopulmonary bypass.
Interventions
DEVICEconventional bandage
DEVICEwarming bandage
Sponsors
Outcomes Research Consortium
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate
Exclusion criteria
* Emergency surgery * Pre - or postoperative on intraaortic balloon pump * Preoperative mechanical ventilation * Postoperative respiratory failure * Postoperative extracorporal membrane oxygenation * Left ventricular function \< 40% * Fever (core temperature \> 38 °C) or current infection * No anticipated or no definitive primary closure of surgical wound.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Oxygen Tension in the Sternal Wound | 8 hours | Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision. |
Countries
Austria
Participant flow
Recruitment details
research personnel will screen the patient list one day before surgery to identify eligible patients
Participants by arm
| Arm | Count |
|---|---|
| Heart Surgery, Wound Infection, Conventional Bandage konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound | 3 |
| Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen | Heart Surgery, Wound Infection, Conventional Bandage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 5 | 55 years STANDARD_DEVIATION 5 | 55 years STANDARD_DEVIATION 5 |
| Region of Enrollment Austria | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Tissue Oxygen Tension in the Sternal Wound
Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.
Time frame: 8 hours
Population: It was not possible to analyse the data because there was not enough data from the recruited population.