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Effects of Photobiomodulation With Red and Infrared Low-level Laser Diodes in Individuals Undergoing Rhinoplasty at a Single Centre: Protocol for a Randomized, Double-blind, Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This single-centre, randomized, double-blind, controlled clinical trial aims to evaluate the effectiveness of preoperative photobiomodulation (PBM) with red and infrared wavelengths in reducing periorbital edema in patients undergoing rhinoplasty. Sixty participants will be randomized to receive either active PBM or sham PBM one hour before surgery. The primary outcome is periorbital edema on postoperative day 3, assessed using the Hoffmann clinical scale, with standardized photographic analysis using ImageJ as a complementary measure. Secondary outcomes include the time course of periorbital edema, periorbital ecchymosis, postoperative pain, nasal tip skin thickness, analgesic consumption, and patient-reported functional and aesthetic outcomes assessed with the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS). Participants will be followed for up to 12 months postoperatively

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• Age 18 to 60 years

• ASA physical status I or II

• No comorbidities (no pre-existing diseases)

• Scheduled for primary open rhinoplasty with piezo-assisted osteotomies

Locations
Other Locations
Brazil
Hospital Paulista de Otorrinolaringologia
RECRUITING
São Paulo
Contact Information
Primary
Cinthya CG Duran, PhD
cinthya.cgduran@gmail.com
5511981628831
Time Frame
Start Date: 2026-01-30
Estimated Completion Date: 2030-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Photobiomodulation Group
Participants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care.
Sham_comparator: Simulation of Photobiomodulation Group
Participants will receive a sham photobiomodulation procedure one hour before rhinoplasty, in addition to standard surgical and perioperative care.
Related Therapeutic Areas
Sponsors
Leads: University of Nove de Julho

This content was sourced from clinicaltrials.gov