Effect of Postoperative Ozonated Oil Dressing on Early Wound Inflammation After Open Mesh Inguinal Hernia Repair: A Prospective Randomized Pilot Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Composite Wound Inflammation Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Surgeons and clinical staff applying the dressing are not blinded due to the nature of the intervention and the characteristic odor of ozonated oil. Participants are not informed of group allocation and are unable to distinguish the dressing content. Outcome assessors, wound photograph evaluators, and statisticians are blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ozonated Oil Dressing
Participants receive a sterile gauze dressing impregnated with CE-certified ozonated oil applied to the surgical incision after skin closure. The dressing is changed once daily for the first 48 hours, followed by standard wound care.
干预措施: ozonated oil (Drug)
Standard Sterile Dressing
Participants receive a standard sterile dry dressing applied to the surgical incision after skin closure. The dressing is removed within 24-48 hours postoperatively, and subsequent wound care is continued according to routine institutional practice.
干预措施: Standard Sterile Dressing (Other)
结局指标
主要结局
Composite Wound Inflammation Score
时间窗: 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.
次要结局
- Wound Surface Temperature Difference(Postoperative day 3)
- Postoperative Pain Score(6 hours, 24 hours, and postoperative day 3)
- Cosmetic Outcome Score(Postoperative day 30)
- Additional Antibiotic Use or Unplanned Healthcare Visits(Within 30 postoperative days)
- Surgical Site Infection(Within 30 postoperative days)
研究者
Alirıza Erdoğan
Medical doctor, General surgery
Nigde Omer Halisdemir University