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

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

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Key information

Conditions

Cleft Palate Cleft Lip Cleft Lip and Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month–13 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsspital Basel

Basel, 4310, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with orofacial clefts, who undergo routine cleft repair

Exclusion criteria

missing datasets
no signed consent for research.

Treatment and study plan

Primary outcomes

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

Time frame: 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 outcomes

Status of wound healing

Time frame: at 3 month and 6 month after surgery

status of wound healing, fistula formation
Perioperative Complications

Time frame: 6 months
- Intraoperative complications, classified according to the Definition and Classification of Intraoperative Complications (ClassIntra)
- Postoperative complications, graded using the Clavien-Dindo classification

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2026
First posted: Mar 18, 2019
Registry last updated: Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed