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

Not Applicable

Terminated

• Conditions: Cardiac Surgery
• Interventions: Device: warming bandage; Device: conventional bandage

• Registration Number: NCT00545506
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Study Start: 2007-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2010-07-22
• Results First Submitted QC: 2010-08-30
• Results First Posted: 2010-09-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
warming bandage	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.
conventional bandage	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria