The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
Study Details
Study Description
Brief Summary
Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: conventional bandage conventional bandage on sternal wound after skin closure after cardiac surgery. conventional gauze covered with elastic adhesive (Medipore™ Dress-it) The designated bandage will be positioned in the operating room by the surgeons after the skin will be closed. The conventional elastic bandage consists of several layers of gauze covered with a special adhesive bandage |
Device: conventional bandage
|
| Active Comparator: warming bandage 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 surface temperature of heating card is fixed at 38°C, and heat is usually provided for two hours at a time. That is, the experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle. |
Device: warming bandage
|
Outcome Measures
Primary Outcome Measures
- Tissue Oxygenation Levels [2 years]
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
- Outcomes Research Consortium
Investigators
- Principal Investigator: Barbara Kabon, MD, Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria
- Principal Investigator: Helmut Hager, MD, Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1.0
Study Results
Participant Flow
| Recruitment Details | research personnel will screen the patient list one day before surgery to identify eligible patients |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Heart Surgery, Wound Infection, Conventional Bandage | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen |
|---|---|---|
| Arm/Group Description | konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound | 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 |
| Period Title: Overall Study | ||
| STARTED | 3 | 3 |
| COMPLETED | 3 | 3 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Heart Surgery, Wound Infection, Conventional Bandage | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen | Total |
|---|---|---|---|
| Arm/Group Description | konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound | 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 | Total of all reporting groups |
| Overall Participants | 20 | 20 | 40 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
100%
|
20
100%
|
40
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
55
(5)
|
55
(5)
|
55
(5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
20
100%
|
20
100%
|
40
100%
|
| Region of Enrollment (participants) [Number] | |||
| Austria |
20
100%
|
20
100%
|
40
100%
|
Outcome Measures
| Title | Tissue Oxygenation Levels |
|---|---|
| Description | |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Tissue Oxygen Tension in the Sternal Wound |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Heart Surgery, Wound Infection, Conventional Bandage | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen |
|---|---|---|
| Arm/Group Description | konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound | 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 |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Heart Surgery, Wound Infection, Conventional Bandage | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen | ||
| Arm/Group Description | konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound | 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 | ||
All Cause Mortality |
||||
| Heart Surgery, Wound Infection, Conventional Bandage | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Heart Surgery, Wound Infection, Conventional Bandage | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Heart Surgery, Wound Infection, Conventional Bandage | Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Helmut Hager |
|---|---|
| Organization | Dep. Anesthesia And Intensive Care |
| Phone | +43 1 40400 4102 |
| helmut.hager@meduniwien.ac.at |
- 1.0