Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paraffin Oil.
- Who it may be relevant to
- Registry conditions: Pressure Injury, Skin Lesions, Skin Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR RCT)
Overview
This randomized controlled trial aims to evaluate the effectiveness of topical paraffin oil application in preventing tourniquet-related skin lesions in patients undergoing upper extremity surgery. Pneumatic tourniquets are commonly used to provide a bloodless surgical field; however, they may cause skin complications such as erythema, edema, abrasions, blisters, and burns. In this study, adult patients undergoing elective upper extremity surgery will be randomly assigned to either an intervention group receiving topical paraffin oil application in addition to routine protective dressing or a control group receiving routine care only. Skin integrity will be assessed immediately after tourniquet removal and at 30 and 60 minutes postoperatively using standardized skin assessment criteria. The findings of this study are expected to contribute to the development of effective, simple, and cost-efficient strategies to prevent tourniquet-related skin complications and improve patient safety and postoperative comfort.
Detailed description
Pneumatic tourniquets are widely used in upper extremity surgeries to provide a bloodless surgical field, allowing better visualization and surgical precision. Despite their benefits, tourniquet application may lead to various complications, particularly skin-related injuries such as erythema, edema, abrasions, blisters, and burns. These complications are often associated with pressure, friction, and prolonged application time.
Current preventive strategies include the use of protective padding materials; however, these methods do not completely eliminate the risk of skin damage. Strengthening the skin barrier using topical agents may provide an additional protective effect. Paraffin oil, known for its barrier-forming and moisturizing properties, has the potential to reduce mechanical stress and transepidermal water loss, thereby protecting the skin.
This study is designed as a prospective, two-arm, parallel-group randomized controlled trial conducted in a single center. Eligible adult patients undergoing elective upper extremity surgery will be randomly assigned to either the intervention group (paraffin oil application plus routine care) or the control group (routine care only) using a computer-generated block randomization method.
The intervention will involve the application of topical paraffin oil to the skin area where the pneumatic tourniquet will be placed before surgery. Both groups will receive standard surgical and anesthetic care according to institutional protocols.
Skin integrity will be evaluated immediately after tourniquet removal and at 30 and 60 minutes postoperatively using standardized pressure injury classification criteria. Data will be collected using structured forms, and statistical analysis will be performed to compare the incidence and severity of skin lesions between the groups.
This study aims to provide evidence on the effectiveness of a simple, low-cost, and easily applicable intervention for preventing tourniquet-related skin complications. The results may contribute to improving clinical practice guidelines and enhancing patient safety in surgical settings.
Interventions
- Other Paraffin Oil
Topical paraffin oil is applied to the skin area before tourniquet placement.
Primary outcome measures
- Incidence of Tourniquet-Related Skin Injury [Time frame: At 0, 30, and 60 minutes after tourniquet removal]
Secondary outcome measures (2)
- Severity of Skin Injury [Time frame: At 0, 30, and 60 minutes after tourniquet removal]
- Medical Device-Related Pressure Injury Risk Score [Time frame: At 0 minutes after tourniquet removal]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Turkey (Türkiye) · 1 center
- Kartal Dr. Lütfi Kırdar City Hospital Istanbul, Turkey — Istanbul
Identifiers
NCT: NCT07523958 · TURNIKE-PARAFIN-RCT-2026