Actively Recruiting
Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR RCT)
Led by Istanbul Medipol University Hospital · Updated on 2026-06-04
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
I
Istanbul Medipol University Hospital
Lead Sponsor
K
Kartal Dr. Lütfi Kirdar City Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of topical paraffin oil to prevent skin injuries caused by pneumatic tourniquets in adults undergoing elective upper extremity surgery. Pneumatic tourniquets help create a bloodless surgical field but may cause skin problems such as redness, swelling, abrasions, blisters, and burns due to pressure and friction. This randomized controlled trial aims to find a simple, cost-effective way to protect the skin during surgery and improve patient safety and comfort. Participants will be randomly assigned to one of two groups: one will receive paraffin oil applied to the skin before tourniquet placement in addition to the usual protective dressing, while the other will receive only the routine dressing. Both groups will receive standard surgical and anesthetic care. Skin condition will be checked immediately after the tourniquet is removed and again at 30 and 60 minutes after surgery using standardized assessment tools. During the study, participants will undergo skin evaluations at these specific times to monitor any signs of injury. Data will be collected systematically and analyzed to compare the number and severity of skin lesions between groups. The research team will also assess the risk score for pressure injuries at tourniquet removal. Participation involves following study procedures and providing informed consent, with safety and compliance monitored throughout the trial period.
CONDITIONS
Brief Title
Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for elective upper extremity surgery requiring pneumatic tourniquet application
- ASA physical status I-III
- Body mass index (BMI) less than 30 kg/m²
- Able to provide informed consent
- Willing to participate in the study
You will not qualify if you...
- Age under 18 years
- Known skin 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 or higher)
- Emergency surgery
- Transferred to intensive care after surgery
- Major postoperative complications such as hematoma, seroma, nerve injury, or significant bleeding
- Unable to communicate or follow study procedures
- Withdrawal from the study at any time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants receive topical paraffin oil application or routine protective dressing before tourniquet placement during elective upper extremity surgery.
1 surgical visit (in-person)
Duration - 1 hour after surgery
Participants are evaluated for skin integrity immediately after tourniquet removal and at 30 and 60 minutes postoperatively using standardized criteria.
3 post-operative assessments (in-person)
Trial Site Locations
Total: 1 location
1
Kartal Dr. Lütfi Kırdar City Hospital Istanbul, Turkey
Istanbul, Turkey (Türkiye), 34760
Actively Recruiting
Research Team
M
Muzeyyen Ataseven, PhD, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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