Actively Recruiting
Effect of Postoperative Ozonated Oil Dressing on Early Wound Inflammation After Open Mesh Inguinal Hernia Repair: A Prospective Randomized Pilot Controlled Trial
Led by Nigde Omer Halisdemir University · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a special wound dressing containing ozonated oil can reduce early wound inflammation after open inguinal hernia surgery. This surgery is common, and while infection rates are low, many patients experience redness, swelling, tenderness, or discomfort at the surgical site shortly after the operation. The study focuses on early wound inflammation rather than infection, aiming to gather preliminary data on the dressing's effects compared to standard care. Participants undergoing elective open inguinal hernia repair will be randomly assigned to one of two groups: one group will receive a sterile gauze dressing impregnated with CE-certified ozonated oil applied immediately after skin closure, with the dressing changed once daily for the first 48 hours, followed by standard wound care. The other group will receive a standard sterile dry dressing removed within 24 to 48 hours postoperatively, with subsequent wound care as per routine institutional practice. During the study, participants will be monitored for wound inflammation on the third day after surgery using a composite clinical and photographic score assessed by blinded evaluators. Additional measures include wound surface temperature, pain levels at several time points, cosmetic healing assessed on day 30, and wound-related complications within 30 days. The study aims to provide data on feasibility and effect size to guide future larger studies, with a total participation window covering the first 30 postoperative days.
CONDITIONS
Brief Title
Postoperative Ozonated Oil Dressing After Open Inguinal Hernia Repair: A Randomized Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - First 48 hours postoperatively
Participants undergo elective open inguinal hernia repair surgery followed by application of the assigned dressing to the surgical incision. Dressings are managed daily during the immediate postoperative period.
Daily visits or dressing changes for 2 days
Duration - Up to 30 days postoperatively
Participants are followed to assess wound inflammation, pain, cosmetic outcome, and any surgical site infections or complications after surgery.
Visits at 6 hours, 24 hours, Day 3, and Day 30 postoperatively
Trial Site Locations
Total: 1 location
1
Dr. Ali Rıza Erdoğan Private Practice Office
Niğde, Niğde Province, Turkey (Türkiye)
Actively Recruiting
Research Team
A
Ali Rıza Erdoğan, Medical doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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