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

NCT ID: NCT00545506

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-11-30

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.

Conditions

Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

conventional bandage

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

warming bandage

Intervention Type: DEVICE

Interventions

conventional bandage

Intervention Type: DEVICE

warming bandage

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Outcomes Research Consortium

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Helmut Hager

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Kabon, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria

Helmut Hager, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra

Locations

Medical University Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

1.0

Identifier Type: -

Identifier Source: org_study_id