Cardiac SurgeryNCT00545506
The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
A study testing conventional bandage and warming bandage in people with Cardiac Surgery, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- conventional bandage and warming bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery
Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections
Read the 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
- Being tested
- conventional bandage, warming bandage
- Keywords
- wound infection, tissue oxygen tension, local warming
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional bandageDevice
warming bandageDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: warming bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: lack of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Outcomes Research Consortium
- Responsible party
- Principal investigator, Helmut Hager, Medical University of Vienna
- Investigators
- Barbara Kabon, MD, Principal investigator, Medical University Vienna,Spitalgasse 23, 1090 Vienna, AustriaHelmut Hager, MD, Principal investigator, Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545506
- Sponsor's protocol ID
- 1.0
- Status last verified
- Mar 2024
- First submitted
- 16 Oct 2007
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00545506
- Acronym / sponsor ID
- 1.0
- Conditions
- Cardiac Surgery
- Keywords
- wound infection, tissue oxygen tension, local warming
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of eligible patients
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Outcomes Research Consortium
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 21 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional bandage | Active comparator | Device: conventional bandageconventional 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 |
| warming bandage | Active comparator | Device: warming bandageThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate
Key exclusion criteria (8 listed)
- Emergency surgery
- Pre - or postoperative on intraaortic balloon pump
- Preoperative mechanical ventilation
- Postoperative respiratory failure
- Postoperative extracorporal membrane oxygenation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional bandage | Device | conventional bandage |
| warming bandage | Device | warming bandage |
Primary outcome
Tissue Oxygen Tension in the Sternal Wound
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Kabon, MD principal investigator
Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria
Helmut Hager, MD principal investigator
Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional bandage and warming bandage in people with Cardiac Surgery, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Oxygen Tension in the Sternal Wound (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.