Paraffin oil to protect skin from tourniquet damage during upper limb surgery
Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR RCT)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul Medipol University Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07523958 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.