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

Официальное название

Effect of Postoperative Ozonated Oil Dressing on Early Wound Inflammation After Open Mesh Inguinal Hernia Repair: A Prospective Randomized Pilot Controlled Trial

Обзор

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.

Подробное описание

Early postoperative wound inflammation following open inguinal hernia repair may affect patient comfort, recovery experience, and cosmetic outcome, even in the absence of surgical site infection. Although open mesh inguinal hernia repair is classified as clean surgery, localized inflammatory findings such as erythema, edema, tenderness, and increased wound temperature are commonly observed during the early postoperative period.

Ozonated oil is a CE-certified topical medical product that has been used in routine clinical practice for wound care in dermatology, plastic surgery, and chronic wound management. Its proposed mechanisms include antimicrobial activity, modulation of local inflammatory response, and support of tissue repair. However, randomized evidence evaluating its effect on early inflammatory response in clean elective surgical incisions remains limited, and most existing studies rely primarily on subjective assessments.

This single-center, prospective, randomized pilot controlled trial is designed to compare ozonated oil-impregnated dressing with standard sterile dressing after elective open inguinal hernia repair. The study focuses on early wound inflammation rather than infection as the primary endpoint, using a composite clinical and photographic inflammation score assessed by blinded evaluators. Objective assessment of local inflammation is supported by non-contact infrared wound surface temperature measurement.

Due to the low expected incidence of surgical site infection in this surgical setting, the study is not powered to detect statistically significant differences in infection rates. Infection-related outcomes are therefore collected for exploratory purposes only. As a pilot trial, the primary aim is to generate preliminary data on feasibility, effect size, and outcome variability to inform the design of future larger-scale randomized studies.

Вмешательства

• Препарат 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.
• Другое 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.

Первичные конечные точки

• Composite Wound Inflammation Score [Срок оценки: Postoperative day 3]

Вторичные конечные точки (5)

• Wound Surface Temperature Difference [Срок оценки: Postoperative day 3]
• Postoperative Pain Score [Срок оценки: 6 hours, 24 hours, and postoperative day 3]
• Cosmetic Outcome Score [Срок оценки: Postoperative day 30]
• Surgical Site Infection [Срок оценки: Within 30 postoperative days]
• Additional Antibiotic Use or Unplanned Healthcare Visits [Срок оценки: Within 30 postoperative days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Dr. Ali Rıza Erdoğan Private Practice Office — Niğde

Идентификаторы

NCT: NCT07328698 · 2025/140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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