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

NCT03877666 | Completed

• 1 other identifier: Microcirculation Palate
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cleft Palate; Cleft Lip and Palate

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Status of wound healing

  at 3 month and 6 month after surgery

• Perioperative Complications

  6 months

Study Arms (3)

control group

cleft lip surgery only

medial incision only

Minimal incision group: palatoplasty using medial-only incisions

lateral incision

Lateral incision group: palatoplasty with lateral releasing incisions

Eligibility Criteria

• Age: 6 Months - 13 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with orofacial clefts undergoing surgical repair of the deformity.

You may qualify if:

• patients with orofacial clefts, who undergo routine cleft repair

You may not qualify if:

• missing datasets
• no signed consent for research.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitätsspital Basel

Basel, Basel, 4310, Switzerland

Location

Related 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.

  PMID: 9727428 BACKGROUND

• 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.

  PMID: 23096613 BACKGROUND

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

  PMID: 28027255 BACKGROUND

MeSH Terms

Conditions

Cleft Palate; Cleft Lip

Condition Hierarchy (Ancestors)

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

Study Officials

• Benito K Benitez, MD DDS MHBA

  University Basel and University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 18, 2019
• Study Start: August 4, 2020
• Primary Completion: December 31, 2025
• Study Completion: March 12, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CH (1)