The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00545506
• Other study ID #: 1.0
• Status: Terminated
• Phase: Phase 3
• First received: October 16, 2007
• Last updated: August 30, 2010
• Start date: November 2007
• Est. completion date: November 2009

Study information

• Verified date: August 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Device:
• conventional bandage

• warming bandage

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Outcomes Research Consortium

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue Oxygenation Levels		2 years	No
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.	8 hours	No