Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07809308
NA

Clinical Investigation of an Ozonated Oil for the Regeneration and Healing of Surgical Wounds in Patients Undergoing Breast Surgery

Sponsor: Laboratorios Ozoaqua

View on ClinicalTrials.gov

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

DEVICE

ozonated oil

OZOAQUA MD Ozonated Oil + chlorhexidine

OTHER

Non ozonated oil

Non ozonated oil + chlorhexidine

Locations (2)

Elche General University Hospital

Elche, Spain

Vinalopó University Hospital, Elche

Elche, Spain