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| Sponsors and Collaborators: |
Medical University of Vienna Outcomes Research Consortium |
|---|---|
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00545506 |
Purpose
Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections
| Condition | Intervention | Phase |
|---|---|---|
|
Tisssue Oxygen Tension Tissue Temperature |
Device: warming bandage |
Phase III |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2009 |
| Arms | Assigned Interventions |
|---|---|
|
A: No Intervention
konventional bandage on sternal wound
|
|
|
B: Experimental
warming bandage on sternal wound
|
Device: warming bandage
the warming bandage will be put at the sternal wound after surgery
Device: warming bandage
warming bandage on sternal wound postoperatively
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Edith Fleischmann, MD | +43 1 40400 4100 | edith.fleischmann@meduniwien.ac.at |
| Contact: Barbara Kabon, MD | +43 1 40400 4100 | barbara.kabon@meduniwien.ac.at |
| 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 |
More Information
| Study ID Numbers: | 1.0 |
| Study First Received: | October 16, 2007 |
| Last Updated: | October 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00545506 |
| Health Authority: | Austria: Agency for Health and Food Safety |
|
wound infection tissue oxygen tension local warming |
|
Wound Infection |
