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Clinical Trials in Turkey / NCT07328698
Recruiting Not applicable

Postoperative Ozonated Oil Dressing After Open Inguinal Hernia Repair: A Randomized Pilot Trial

NCT07328698 · tracked via the Priya Life Science Turkey tracker
Sponsor
Nigde Omer Halisdemir University
Phase
Not applicable
Started
2026-02-10
Last updated
2026-02-11

Condition(s) studied

Inguinal Hernia UnilateralPostoperative Wound Inflammation

Investigational drug(s) / intervention(s)

ozonated oilStandard Sterile Dressing

ozonated oil: Ozonated oil-impregnated sterile gauze is applied topically to the surgical incision immediately after skin closure. The dressing is changed once daily for the first 48 hours postoperatively, followed by standard wound care according to institutional routine.

Standard Sterile Dressing: A standard sterile dry dressing is applied to the surgical incision after skin closure and removed within 24-48 hours postoperatively. Subsequent wound care is continued according to routine institutional practice.

Study summary

This study looks at whether a special wound dressing containing ozonated oil can reduce early wound inflammation after open inguinal hernia surgery. Open inguinal hernia repair is a common operation, and although infection rates are low, many patients experience redness, swelling, tenderness, or discomfort at the surgical site during the first days after surgery.

Participants undergoing elective open inguinal hernia repair will be randomly assigned to receive either an ozonated oil-impregnated dressing or a standard sterile dressing after the operation. The main outcome is the level of wound inflammation measured on the third day after surgery. Other outcomes include wound temperature, pain levels, cosmetic healing, and wound-related problems during the first 30 days.

The ozonated oil used in this study is a CE-certified medical product that is already used in routine wound care. This pilot study aims to provide preliminary data to help determine whether ozonated oil dressing may improve early wound healing compared with standard care.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite Wound Inflammation Score — Postoperative day 3
    A composite wound inflammation score ranging from 0 to 12, consisting of erythema, edema, and exudate graded from standardized wound photographs (0-3 points each) and wound tenderness assessed during clinical examination (0-3 points). Wound photographs are independently evaluated by two blinded surgeons.

Trial sites (1)

FacilityCityRegionStatus
Dr. Ali Rıza Erdoğan Private Practice Office Niğde Niğde Province Recruiting

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Other trials for the same condition

Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair Starting soon
Comparison of Quadro-Iliac Plane Block and Transversalis Fascia Plane Block for Open Inguinal Hernia Repair Starting soon
Intrathecal Morphine and Transversalis Fascia Plane Block for Analgesia After Open Inguinal Hernia Repair Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07328698 on ClinicalTrials.gov ↗ ← All trials in Turkey