Trial Outcomes & Findings for RIPC During Free Flap With Preoperative Radiotherapy (NCT NCT03535623)
NCT ID: NCT03535623
Last Updated: 2026-06-11
Results Overview
tissue oxygen saturation of the flap
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
postoperative day 1
Results posted on
2026-06-11
Participant Flow
Participant milestones
| Measure |
Remote Ischemic Conditioning
Remote ischemic conditioning (RIC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.
remote ischemic conditioning (RIC): RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
|
Sham
Sham-RIC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.
Sham-RIC: Sham-RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RIPC During Free Flap With Preoperative Radiotherapy
Baseline characteristics by cohort
| Measure |
Remote Ischemic Conditioning
n=20 Participants
Remote ischemic conditioning (RIC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.
remote ischemic conditioning (RIC): RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
|
Sham
n=19 Participants
Sham-RIC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.
Sham-RIC: Sham-RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=20 Participants
|
65 years
n=20 Participants
|
65 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
South Korea
|
20 participants
n=20 Participants
|
19 participants
n=20 Participants
|
39 participants
n=40 Participants
|
|
Regional tissue oxygen saturation
|
87 %
n=20 Participants
|
84 %
n=20 Participants
|
85 %
n=40 Participants
|
PRIMARY outcome
Timeframe: postoperative day 1tissue oxygen saturation of the flap
Outcome measures
| Measure |
Remote Ischemic Conditioning
n=20 Participants
Remote ischemic conditioning (RIC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.
remote ischemic conditioning (RIC): RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
|
Sham
n=19 Participants
Sham-RIC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.
Sham-RIC: Sham-RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.
|
|---|---|---|
|
Tissue Oxygen Saturation
|
87 percent
Interval 69.0 to 95.0
|
84 percent
Interval 74.0 to 93.0
|
SECONDARY outcome
Timeframe: during the study period until discharge, an average of 17.5 daysNumber of participants who occurred flap complications during the study period
Outcome measures
| Measure |
Remote Ischemic Conditioning
n=20 Participants
Remote ischemic conditioning (RIC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.
remote ischemic conditioning (RIC): RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
|
Sham
n=19 Participants
Sham-RIC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.
Sham-RIC: Sham-RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.
|
|---|---|---|
|
Number of Participants With Flap Complications
|
4 Participants
|
10 Participants
|
Adverse Events
Remote Ischemic Conditioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham
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
Dr Youn Joung Cho, MD, PhD
Seoul National University Hospital
Phone: 82-2-2072-2467
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place