Assessment of the Influence of Cleft Repair on Microcirculation of the Palate

University Hospital, Basel, Switzerland77 enrolled

Overview

Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cleft Palate Cleft Lip and Palate

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 13 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * patients with orofacial clefts, who undergo routine cleft repair Exclusion Criteria: * missing datasets * no signed consent for research.

Locations (1)

Universitätsspital Basel

Basel, Basel, Switzerland

Outcomes

Primary Outcomes

Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured

The difference and impact of our routine surgical technique on the tissue perfusion of the palate is measured non-invasively with a probe (regional StO2%). Localized measurement of the microvascular hemoglobin oxygen saturation.

Time frame: One measurement before surgery, one measurement immediately after surgery

Secondary Outcomes

Status of wound healing

status of wound healing, fistula formation

Time frame: at 3 month and 6 month after surgery

Perioperative Complications

* Intraoperative complications, classified according to the Definition and Classification of Intraoperative Complications (ClassIntra) * Postoperative complications, graded using the Clavien-Dindo classification

Time frame: 6 months

Data from ClinicalTrials.gov

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