Ozonated oil dressing after open inguinal hernia repair
Effect of Postoperative Ozonated Oil Dressing on Early Wound Inflammation After Open Mesh Inguinal Hernia Repair: A Prospective Randomized Pilot Controlled Trial
This trial tests whether an ozonated oil‑impregnated dressing can reduce early wound redness, swelling, tenderness, and pain after elective open inguinal hernia repair in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Locations | 1 site (Niğde, Niğde Province) |
| Trial ID | NCT07328698 on ClinicalTrials.gov |
What this trial studies
This single-center randomized pilot compares a CE‑certified ozonated oil‑impregnated dressing with a standard sterile dressing in adults undergoing elective unilateral open inguinal hernia repair. Participants are randomly assigned after surgery and wound inflammation is measured primarily on postoperative day 3 using a blinded composite clinical and photographic score, with additional measures of wound temperature, pain, cosmetic healing, and wound‑related problems through 30 days. The ozonated oil product is already used in routine wound care and is proposed to have antimicrobial and local anti‑inflammatory effects; the study focuses on early inflammatory signs rather than infection. As a pilot trial, it aims to provide preliminary data to help design larger, definitive studies.
Who should consider this trial
Good fit: Adults 18–75 years old with ASA physical status I–III who are scheduled for elective, unilateral open inguinal hernia repair and can provide informed consent are ideal candidates.
Not a fit: Patients with recurrent or emergency (incarcerated/strangulated) hernias, those undergoing additional procedures, people who are immunosuppressed, on anticoagulants or antiplatelets, have active dermatologic disease at the incision, known bleeding disorders, or who are pregnant would not be eligible or are unlikely to benefit.
Why it matters
Potential benefit: If successful, the dressing could reduce early postoperative inflammation and discomfort and improve cosmetic healing after open inguinal hernia repair.
How similar studies have performed: Ozonated oil is used in routine wound care and small or observational reports suggest possible benefit, but randomized evidence for reducing early inflammation after clean elective incisions is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 75 years * ASA physical status I-III * Scheduled for elective, unilateral open inguinal hernia repair * Able to provide written informed consent Exclusion Criteria: * Emergency inguinal hernia (incarcerated or strangulated) * Recurrent inguinal hernia * Concomitant surgical procedures during the same operation * Immunosuppression or long-term systemic steroid use * Use of anticoagulant or antiplatelet therapy * Known bleeding disorders * Active dermatologic disease at the surgical incision site * Pregnancy
Where this trial is running
Niğde, Niğde Province
- Dr. Ali Rıza Erdoğan Private Practice Office — Niğde, Niğde Province, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Ali Rıza Erdoğan, Medical doctor — Private practice office
- Study coordinator: Ali Rıza Erdoğan, Medical doctor
- Email: dralirizaerdogan@gmail.com
- Phone: +905333558377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.