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

NCT00545506 | Terminated Results DMC

• 1 other identifier: 1.0
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Surgery

Keywords

wound infection; tissue oxygen tension; local warming

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

conventional bandage

ACTIVE COMPARATOR

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

warming bandage

ACTIVE COMPARATOR

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

Interventions

conventional bandage DEVICE

conventional bandage

warming bandage DEVICE

warming bandage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead
• Outcomes Research Consortium: collaborator

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Limitations and Caveats

Tissue oxygen tension maybe difficult to measure in the sternal wound

Results Point of Contact

• Title: Helmut Hager
• Organization: Dep. Anesthesia And Intensive Care

helmut.hager@meduniwien.ac.at

+43 1 40400 4102

Study Officials

• Barbara Kabon, MD

  Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria

  PRINCIPAL INVESTIGATOR

• Helmut Hager, MD

  Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 20, 2024
• Results First Posted: September 21, 2010

Record last verified: 2024-03

Locations

AU (1)