The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Surgery |
Device: conventional bandage Device: warming bandage |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Basic Science |
| Official Title: | The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery |
- Tissue Oxygenation Levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Tissue Oxygen Tension in the Sternal Wound [ Time Frame: 8 hours ] [ Designated as safety issue: No ]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.
| Enrollment: | 3 |
| Study Start Date: | November 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Austria | |
| Medical University Vienna | |
| Vienna, Austria, 1090 | |
| 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
No publications provided
| Responsible Party: | Edith Fleischmann MD, Dep. Anesthesiology and Intensiv Care |
| ClinicalTrials.gov Identifier: | NCT00545506 History of Changes |
| Other Study ID Numbers: | 1.0 |
| Study First Received: | October 16, 2007 |
| Results First Received: | July 22, 2010 |
| Last Updated: | August 30, 2010 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Medical University of Vienna:
|
wound infection tissue oxygen tension local warming |
ClinicalTrials.gov processed this record on October 17, 2012
