Paraffin oil to protect skin from tourniquet damage during upper limb surgery
Official title: Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR RCT)
Run by Istanbul Medipol University Hospital · NCT07523958 · Data updated 2026-11-12
This trial will try applying topical paraffin oil to the skin of adults having elective upper extremity surgery to see if it prevents tourniquet-related redness, blisters, or abrasions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Istanbul Medipol University Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | June 2026 |
| Study ends | July 2026 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07523958 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) scheduled for elective upper extremity surgery with pneumatic tourniquet use, ASA I–III, BMI <30 kg/m², who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with preexisting dermatologic disease at the tourniquet site, known allergy to paraffin oil, obesity (BMI ≥30), emergency surgery, or expected ICU transfer postoperatively are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, two-arm randomized controlled trial comparing topical paraffin oil plus routine protective dressing versus routine protective dressing alone in adults undergoing elective upper extremity surgery with a pneumatic tourniquet. Eligible patients are randomized using a computer-generated block method and the paraffin oil is applied to the skin area where the tourniquet will be placed before surgery. Skin integrity is assessed immediately after tourniquet removal and again at 30 and 60 minutes postoperatively using standardized skin assessment criteria. The trial aims to determine whether a simple, low-cost topical barrier can reduce short-term tourniquet-related skin complications.
Why it matters
Potential benefit: If successful, this could provide a simple, low-cost way to reduce tourniquet-related skin injuries during arm and hand surgeries.
How similar studies have gone: While barrier moisturizers and protective dressings have shown benefit in reducing friction-related skin injuries in other settings, using paraffin oil specifically to prevent tourniquet-related lesions is novel and not widely studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
IInclusion Criteria: * Age ≥18 years * Patients scheduled for elective upper extremity surgery requiring pneumatic tourniquet application * ASA physical status I-III * Body mass index (BMI) \<30 kg/m² * Ability to provide informed consent * Willingness to participate in the study Exclusion Criteria: * Age \<18 years * Known dermatological disease or existing skin lesion at the tourniquet application site * Allergy or sensitivity to paraffin oil or related substances * Severe systemic disease (ASA IV or higher) * Obesity (BMI ≥30 kg/m²) * Emergency surgery * Patients transferred to intensive care postoperatively * Development of major postoperative complications (e.g., hematoma, seroma, nerve injury, significant bleeding) * Inability to communicate or comply with study procedures * Withdrawal from the study at any time
Where it's running
-
Kartal Dr. Lütfi Kırdar City Hospital Istanbul, Turkey
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Muzeyyen Ataseven, PhD, RN
- Email: muzeyyenataseven@hotmail.com
- Phone: +90 505 229 9474
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.