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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03877666

Enrollment

Registered

2019-03-18

Start date

2020-08-04

Completion date

2026-03-12

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate, Cleft Palate

Keywords

cleft lip and palate, cleft palate, palatal microcirculation, tissue oxygenation, surgical technique, anatomy, palatoplasty

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 13 Months

Healthy volunteers

Yes

Inclusion criteria

* patients with orofacial clefts, who undergo routine cleft repair

Exclusion criteria

* missing datasets * no signed consent for research.

Design outcomes

Primary

Measure	Time frame	Description
Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured	One measurement before surgery, one measurement immediately after surgery	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.

Secondary

Measure	Time frame	Description
Status of wound healing	at 3 month and 6 month after surgery	status of wound healing, fistula formation
Perioperative Complications	6 months	* Intraoperative complications, classified according to the Definition and Classification of Intraoperative Complications (ClassIntra) * Postoperative complications, graded using the Clavien-Dindo classification

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORBenito K Benitez, MD DDS MHBA

University Basel and University Hospital Basel

Outcome results