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Search / Trial NCT07033039

Evaluation of Preventive Photobiomodulation in Postoperative Rhinoplasty Edema

Launched by UNIVERSITY OF NOVE DE JULHO · Jun 13, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Photobiomodulation Low Level Laser Therapy Postoperative Inflammation

ClinConnect Summary

This clinical trial is studying whether a special light treatment called photobiomodulation (PBM), given before nose surgery (rhinoplasty), can help reduce swelling around the eyes after the operation. The study will include 60 patients who will be randomly divided into two groups: one group will receive the light therapy before surgery, and the other group will not. The researchers will carefully measure swelling, bruising, pain, skin thickness, and the need for pain medications after surgery. They will also use a questionnaire to understand how patients feel about the appearance and function of their nose over time. Follow-up visits will happen several times within the first year after surgery to track recovery and any side effects.

To join the study, patients must be generally healthy adults without other medical problems, scheduled for their first rhinoplasty surgery. People who take blood thinners, anti-inflammatory drugs, or steroids, or who need a revision or more complex nose surgery, won’t be eligible. Participants can expect to receive the light therapy before surgery if assigned to that group, and then have regular check-ups to monitor their healing. This study aims to find out if this light treatment is a safe and effective way to reduce swelling and improve recovery after rhinoplasty.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ASA physical status I or II
  • No comorbidities or pre-existing medical conditions
  • Scheduled for primary rhinoplasty -
  • Exclusion Criteria:
  • Use of anticoagulant, anti-inflammatory, or corticosteroid medications
  • Indications for secondary or revision rhinoplasty
  • Indications for closed rhinoplasty
  • Surgical procedures performed using instruments other than a 3 mm curved angled osteotome with a guide for osteotomies
  • The occurrence of intraoperative complications, such as hemorrhage or technical difficulties
  • History of previous nasal filler procedures with hyaluronic acid
  • Use of vitamin A derivatives (e.g., oral isotretinoin or topical retinoic acid) within 30 days before surgery
  • Known allergy to any medications listed as mandatory for intraoperative or postoperative care
  • -

About University Of Nove De Julho

The University of Nove de Julho (UNINOVE) is a prestigious educational institution located in São Paulo, Brazil, renowned for its commitment to advancing research and innovation in the field of health sciences. As a clinical trial sponsor, UNINOVE aims to foster collaboration between academia and the healthcare industry, facilitating the development and evaluation of novel therapeutic interventions. With a robust infrastructure and a team of experienced researchers, the university is dedicated to conducting high-quality clinical trials that adhere to rigorous ethical standards and regulatory guidelines, ultimately contributing to improved health outcomes and the enhancement of medical knowledge.

Locations

Patients applied

0 patients applied

Trial Officials

Cinthya CG Duran, PhD

Principal Investigator

University of Nove de Julho

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported