Trial Outcomes & Findings for The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery (NCT NCT00545506)

Last Updated: 2024-08-20

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

8 hours

Results posted on

2024-08-20

Participant Flow

research personnel will screen the patient list one day before surgery to identify eligible patients

Participant milestones

Participant milestones
Measure	Heart Surgery, Wound Infection, Conventional Bandage konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound	Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen warming bandage on sternal wound 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 experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heart Surgery, Wound Infection, Conventional Bandage n=3 Participants konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound	Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen n=3 Participants warming bandage on sternal wound 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 experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 5 • n=5 Participants	55 years STANDARD_DEVIATION 5 • n=7 Participants	55 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Austria	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Population: It was not possible to analyse the data because there was not enough data from the recruited population.

Outcome measures

Outcome data not reported

Adverse Events

Heart Surgery, Wound Infection, Conventional Bandage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Helmut Hager

Dep. Anesthesia And Intensive Care

Phone: +43 1 40400 4102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place