Clinical trial · Interventional
RIPC During Free Flap With Preoperative Radiotherapy
Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ischemic Reperfusion Injury | — | UNRESOLVED | — |
| Other Reconstructive Surgery | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| remote ischemic preconditioning (RIPC) | Other | — | UNRESOLVED |
| Sham-RIPC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RIPC
- description
- 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.
- interventionNames
- Other: remote ischemic preconditioning (RIPC)
- type
- SHAM_COMPARATOR
- label
- Sham-RIPC
- description
- 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.
- interventionNames
- Other: Sham-RIPC
Primary outcomes (1)
- measure
- Tissue Oxygen Saturation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Adult head and neck cancer patients undergoing free flap reconstructive surgery with preoperative radiotherapy Exclusion Criteria: * Radiotherapy within 4 weeks * Body mass index \< 18 kg/m\^2 or \> 35 kg/m\^2 * Presence of AV fistula at the arm, any reason to protect arms * Presence of vascular abnormality or discomfort at arms * Peripheral vascular disease, peripheral neuropathy, or coagulopathy * Uncontrolled diabetes mellitus * Preoperative use of beta-blockers * Refuse to enrol
References
Publications (1)
- DERIVEDMin S, Kim JE, Oh HM, Yoon SB, Ahn SH, Cho YJ. Effects of Remote Ischemic Conditioning on Flap Oxygenation in Patients Undergoing Head and Neck Reconstruction and Preoperative Radiotherapy: A Randomized Clinical Trial. J Oral Maxillofac Surg. 2025 Nov;83(11):1421-1430. doi: 10.1016/j.joms.2025.07.010. Epub 2025 Aug 5. PMID 40846225