Postoperative Ozonated Oil Dressing After Open Inguinal Hernia Repair: A Randomized Pilot Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNigde Omer Halisdemir University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Emergency inguinal hernia (incarcerated or strangulated)
Recurrent inguinal hernia
Concomitant surgical procedures during the same operation
Immunosuppression or long-term systemic steroid use
Trial design
Design model
Parallel
Treatments tested in this trial
ozonated oil
DrugOzonated 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
Other interventionA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Ozonated Oil DressingExperimental treatment 1 intervention
Group B: Standard Sterile DressingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite Wound Inflammation Score
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.
Time frame
Postoperative day 3Secondary outcomes
1
Wound Surface Temperature Difference
Difference between mean surgical wound surface temperature and contralateral symmetrical skin temperature measured using a non-contact infrared thermometer.
Time frame
Postoperative day 32
Postoperative Pain Score
Pain intensity at the surgical site measured using a 0-10 visual analog scale (VAS).
Time frame
6 hours, 24 hours, and postoperative day 33
Cosmetic Outcome Score
Patient-reported cosmetic satisfaction assessed using a 0-10 visual analog scale and photographic evaluation using the Hollander Wound Evaluation Score.
Time frame
Postoperative day 304
Surgical Site Infection
Incidence of surgical site infection defined according to Centers for Disease Control and Prevention (CDC) criteria, collected for exploratory analysis.
Time frame
Within 30 postoperative daysSponsors and contacts
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Source ClinicalTrials.gov