Trial · NCT07887256
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
NCT07887256, Not yet recruiting, Leiden University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study. Trials, record NCT07887256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887256
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
- NCT number
- NCT07887256
- Status
- Not yet recruiting
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Leiden University Medical Center
- Conditions
- Reconstructive Surgery, Flap Monitoring
- Interventions
- Elective free flap surgery, INVOS monitoring
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion successfully maintained monitor | From day of surgery (day 0) until day 3 postoperative | The proportion of patients (%) in whom continuous tissue oximetry monitoring was successfully maintained for the entire postoperative period. |
| Secondary | Surgical re-exploration | From day of surgery (day 0) until day 3 postoperative | Surgical re-exploration performed because of suspected vascular compromise of the free flap. Yes/no. |
| Secondary | Flap failure | From day of surgery (day 0) until day 3 postoperative | Flap failure. Yes/no. |
| Secondary | Flap risk score | From day of surgery (day 0) until day 3 posteroperative | 0= no risk parameters present 6= all risk parameters present. Risk parameters are: color, consistency, capillary refill, temperature, doppler signal, clinical suspiscion. Parameters score 0 if the parameter is clinically judged to be normal/optimal and 1 if parameter is clinically judged to be suboptimal |
| Secondary | Postoperative complications | From day of surgery (day 0) until day 3 posteroperative | According to Clavien-Dindo scale Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention * IIIa Intervention not under general anesthesia * IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including CNS complications)\* requiring IC/ICU-management * IVa single organ dysfunction (including dialysis) * IVb multiorgandysfunction Grade V Death of a patient |
| Secondary | INVOS risk triggers: absolute drop of StO₂ | From start of INVOS measurements (day 0) until day 3 postoperative | Number of absolute drops of StO₂ \< 60%. |
| Secondary | INVOS risk triggers: relative drop StO₂ | From start of INVOS measurements (day 0) until day 3 postoperative | Number of relative drops of StO₂ ≥20% decrease from baseline sustained ≥30 minutes. |
| Secondary | INVOS risk triggers: flap-to-reference ratio | From start of INVOS measurements (day 0) until day 3 postoperative | Flap-to-reference ratio of \<0.75. Yes/no |
| Secondary | Incidence sensor displacement or detachment | From day of surgery (day 0) until day 3 posteroperative | The incidence of mechanical sensor displacement or complete detachment requiring clinical intervention or sensor replacement within the first 48 hours postoperatively. |
| Secondary | Cumulative duration missing StO2 data | From start INVOS measurement (day 0) until day 3 postoperative | The cumulative duration of missing or uninterpretable tissue oxygen saturation (StO₂) data due to sensor detachment, signal artifacts, or hardware failure, expressed as a percentage (%) of the total monitoring time. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07887256
GET https://conductscience.org/api/trials/v1/NCT07887256/registered