An interventional study of remote ischemic preconditioning (RIPC) and Sham-RIPC in Ischemic Reperfusion Injury, Other Reconstructive Surgery and Radiotherapy, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease. However its protective role in head and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive surgery has not yet been evaluated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap.
Patients undergoing free flap reconstructive surgery for head and neck cancer with preoperative radiotherapy will be randomized to either remote ischemic preconditioning (RIPC) group or control group. On the day of surgery, after induction of anesthesia, RIPC, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) followed by 5-min reperfusion at the upper arm, or sham-RIPC (pressure \< 10 mmHg) will be induced in the RIPC or control group, respectively. Before completion of surgery, RIPC or sham-RIPC will be repeated. Tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Remote ischemic preconditioning (RIPC) 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.
Other: remote ischemic preconditioning (RIPC)
Sham-RIPC 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.
Other: Sham-RIPC
RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.
Tissue Oxygen Saturation
tissue oxygen saturation of the flap
Time frame: postoperative day 1
Number of Participants With Flap Complications
Number of participants who occurred flap complications during the study period
Time frame: during the study period until discharge, an average of 17.5 days
| Milestone | Remote Ischemic Conditioning | Sham |
|---|---|---|
| Started | 22 | 22 |
| Completed | 20 | 19 |
| Not completed | 2 | 3 |
tissue oxygen saturation of the flap
| percent | Remote Ischemic Conditioning | Sham |
|---|---|---|
| Tissue Oxygen Saturation | 87 (69 to 95) | 84 (74 to 93) |
Number of participants who occurred flap complications during the study period
| Participants | RIPC | Sham-RIPC |
|---|---|---|
| Number of Participants With Flap Complications | 4 | 10 |
Collected over through study completion, an average of 17.5 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Remote Ischemic Conditioning | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Sham | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Median | 65 (55 to 72) | 65 (59 to 69) | 65 (56 to 70) |
| Sex: Female, Male(Participants) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 14 | 14 | 28 |
| Race (NIH/OMB)(Participants) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 20 | 19 | 39 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| South Korea | 20 | 19 | 39 |
| Regional tissue oxygen saturation(%) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Median | 87 (69 to 95) | 84 (74 to 93) | 85 (74 to 94) |
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Seoul National University Hospital