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

NCT07328698 | Recruiting

• 1 other identifier: 2025/140
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inguinal Hernia Unilateral; Postoperative Wound Inflammation

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

Outcome Measures

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.

  Postoperative day 3

Secondary Outcomes (5)

• Wound Surface Temperature Difference

  Postoperative day 3

• Postoperative Pain Score

  6 hours, 24 hours, and postoperative day 3

• Cosmetic Outcome Score

  Postoperative day 30

• Surgical Site Infection

  Within 30 postoperative days

• Additional Antibiotic Use or Unplanned Healthcare Visits

  Within 30 postoperative days

Study Arms (2)

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.

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.

Other: Standard Sterile Dressing

Interventions

ozonated oil DRUG

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.

Ozonated Oil Dressing

Standard Sterile Dressing OTHER

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.

Standard Sterile Dressing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Dr. Ali Rıza Erdoğan Private Practice Office

Niğde, Niğde Province, Turkey (Türkiye)

RECRUITING

Study Officials

• Ali Rıza Erdoğan, Medical doctor

  Private practice office

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Rıza Erdoğan, Medical doctor

CONTACT

+905333558377; dralirizaerdogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, General surgery

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: February 10, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)