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NCT03877666 Clinical Trial

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

Cleft Lip and Palate Clinical Trial

Official title:
Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03877666
Other study ID # Microcirculation Palate
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 4, 2020
Est. completion date December 2024

Study information
Verified date May 2024
Source University Hospital, Basel, Switzerland
Contact Benito K Benitez, MD DDS MHBA
Phone 615565285
Email benito.benitez@usb.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 13 Months
Eligibility Inclusion Criteria: - patients with orofacial clefts, who undergo routine cleft repair Exclusion Criteria: - missing datasets - no signed consent for research.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Universitätsspital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Huang MH, Lee ST, Rajendran K. Clinical implications of the velopharyngeal blood supply: a fresh cadaveric study. Plast Reconstr Surg. 1998 Sep;102(3):655-67. doi: 10.1097/00006534-199809030-00007. — View Citation

Mueller AA, Schumann D, Reddy RR, Schwenzer-Zimmerer K, Mueller-Gerbl M, Zeilhofer HF, Sailer HF, Reddy SG. Intraoperative vascular anatomy, arterial blood flow velocity, and microcirculation in unilateral and bilateral cleft lip repair. Plast Reconstr Surg. 2012 Nov;130(5):1120-1130. doi: 10.1097/PRS.0b013e318267d4fb. — View Citation

Woo AS. Evidence-Based Medicine: Cleft Palate. Plast Reconstr Surg. 2017 Jan;139(1):191e-203e. doi: 10.1097/PRS.0000000000002854. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. One measurement before surgery, one measurement immediately after surgery
Secondary Status of wound healing status of wound healing, fistula formation at 3 month and 6 month after surgery
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