Inguinal Hernia UnilateralOZONE-HERNIANCT07328698
Postoperative Ozonated Oil Dressing After Open Inguinal Hernia Repair: A Randomized Pilot Trial
A study testing ozonated oil and Standard Sterile Dressing in people with Inguinal Hernia Unilateral and Postoperative Wound Inflammation, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inguinal Hernia Unilateral, Postoperative Wound Inflammation
- What is being tested?
- ozonated oil and Standard Sterile Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Ali Rıza Erdoğan Private Practice Office
Niğde, Niğde Province
Ali Rıza Erdoğan, Medical Doctor, 05333558377, dralirizaerdogan@gmail.com
About this study
Official title: Effect of Postoperative Ozonated Oil Dressing on Early Wound Inflammation After Open Mesh Inguinal Hernia Repair: A Prospective Randomized Pilot Controlled 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.
Read the detailed description
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.
- Being tested
- ozonated oil, Standard Sterile Dressing
- Keywords
- Inguinal hernia repair, Open inguinal hernia surgery, Ozonated oil, Ozonated oil dressing, Postoperative wound inflammation, Surgical wound care, Topical ozone, Pilot randomized controlled trial, Clean surgical wound, Wound surface temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozonated oilDrug
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 DressingOther
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 group | Role | What they receive |
|---|---|---|
| Ozonated Oil Dressing | Experimental | 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. Receives: Drug: ozonated oil |
| Standard Sterile Dressing | Active comparator | 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. Receives: Other: Standard Sterile Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 3
Secondary outcomes (5)
Wound Surface Temperature Difference
Difference between mean surgical wound surface temperature and contralateral symmetrical skin temperature measured using a non-contact infrared thermometer.
Measured: Postoperative day 3
Postoperative Pain Score
Pain intensity at the surgical site measured using a 0-10 visual analog scale (VAS).
Measured: 6 hours, 24 hours, and postoperative day 3
Cosmetic Outcome Score
Patient-reported cosmetic satisfaction assessed using a 0-10 visual analog scale and photographic evaluation using the Hollander Wound Evaluation Score.
Measured: Postoperative day 30
Surgical Site Infection
Incidence of surgical site infection defined according to Centers for Disease Control and Prevention (CDC) criteria, collected for exploratory analysis.
Measured: Within 30 postoperative days
Additional Antibiotic Use or Unplanned Healthcare Visits
Any wound-related antibiotic treatment or unplanned medical visits due to wound complications during the postoperative follow-up period.
Measured: Within 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Feb 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, two-arm, parallel-group randomized pilot trial with 1:1 allocation to ozonated oil dressing versus standard sterile dressing after elective open mesh inguinal hernia repair, with follow-up through postoperative day 30.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alirıza Erdoğan, Nigde Omer Halisdemir University
- Investigators
- Ali Rıza Erdoğan, Medical doctor, Principal investigator, Private practice office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328698
- Sponsor's protocol ID
- 2025/140
- Acronym
- OZONE-HERNIA
- Status last verified
- Feb 2026
- First submitted
- 27 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a single-center pilot study with a small sample size, and the dataset includes clinical and photographic wound data that could pose a risk of re-identification. Data sharing was not planned at the time of study design.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Ozonated Oil Dressing on Early Wound Inflammation After Open Mesh Inguinal Hernia Repair: A Prospective Randomized Pilot Controlled Trial
- ClinicalTrials.gov ID
- NCT07328698
- Acronym / sponsor ID
- OZONE-HERNIA / 2025/140
- Keywords
- Inguinal hernia repair, Open inguinal hernia surgery, Ozonated oil, Ozonated oil dressing, Postoperative wound inflammation, Surgical wound care, Topical ozone, Pilot randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, two-arm, parallel-group randomized pilot trial with 1:1 allocation to ozonated oil dressing versus standard sterile dressing after elective open mesh inguinal hernia repair, with follow-up through postoperative day 30.
| Arm | Type | Receives |
|---|---|---|
| Ozonated Oil Dressing | Experimental | Drug: ozonated oilParticipants 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. |
| Standard Sterile Dressing | Active comparator | Other: Standard Sterile DressingParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozonated oilOzonated 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. | Drug | Ozonated Oil Dressing |
| Standard Sterile DressingA 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. | Other | Standard Sterile Dressing |
Primary outcome
Composite Wound Inflammation Score
Time frame: 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.
5 secondary outcomes
Wound Surface Temperature Difference
Time frame: Postoperative day 3
Postoperative Pain Score
Time frame: 6 hours, 24 hours, and postoperative day 3
Cosmetic Outcome Score
Time frame: Postoperative day 30
Surgical Site Infection
Time frame: Within 30 postoperative days
Additional Antibiotic Use or Unplanned Healthcare Visits
Time frame: Within 30 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a single-center pilot study with a small sample size, and the dataset includes clinical and photographic wound data that could pose a risk of re-identification. Data sharing was not planned at the time of study design.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Rıza Erdoğan, Medical doctor principal investigator
Private practice office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozonated oil and Standard Sterile Dressing in people with Inguinal Hernia Unilateral and Postoperative Wound Inflammation, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Rıza Erdoğan, Medical doctor (+905333558377, dralirizaerdogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Wound Inflammation Score (time frame: Postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.