Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Investigation of an Ozonated Oil for the Regeneration and Healing of Surgical Wounds in Patients Undergoing Breast Surgery
Sponsor: Laboratorios Ozoaqua
Summary
This is a multicentre, prospective, randomised, double-blind, placebo-controlled clinical study designed to evaluate the regenerative and wound-healing efficacy of OZOAQUA MD OZONATED OIL in surgical wounds in patients undergoing breast surgery. The study includes 50 participants, randomly assigned in a 1:1 ratio to two treatment groups. The primary objective is to determine whether ozonated oil improves and accelerates postoperative wound healing compared with placebo. Additional objectives include characterising the course of wound healing, comparing the user experience associated with both products, and correlating clinical and photographic assessments with instrumental measurements obtained using dermatological probes. Follow-up assessments are performed approximately 7, 15, 30, and 60 days after surgery. Evaluations include standardised image capture, scar assessment using the Vancouver Scar Scale and POSAS, and measurement of skin parameters using the Mexameter® and Cutometer®. The study is conducted at Vinalopó University Hospital and Elche General University Hospital.
Key Details
Gender
All
Age Range
25 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-02-06
Completion Date
2026-12
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
ozonated oil
OZOAQUA MD Ozonated Oil + chlorhexidine
Non ozonated oil
Non ozonated oil + chlorhexidine
Locations (2)
Elche General University Hospital
Elche, Spain
Vinalopó University Hospital, Elche
Elche, Spain