Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul Medipol University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Paraffin Oil
Other interventionTopical paraffin oil is applied to the skin area before tourniquet placement.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Paraffin Oil GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of Tourniquet-Related Skin Injury
The incidence of skin injury at the tourniquet application site will be assessed immediately after tourniquet removal (0 minutes) and at 30 and 60 minutes post-removal using clinical evaluation.
Time frame
At 0, 30, and 60 minutes after tourniquet removalSecondary outcomes
1
Severity of Skin Injury
The severity of skin injury at the tourniquet site will be evaluated at 0, 30, and 60 minutes after tourniquet removal using a standardized pressure injury classification system based on clinical observation.
Time frame
At 0, 30, and 60 minutes after tourniquet removal2
Medical Device-Related Pressure Injury Risk Score
The risk of pressure injuries associated with medical devices will be assessed immediately after the tourniquet is removed using a standard risk assessment scale. The medical device-related pressure injury risk assessment scale consists of 8 items, and the risk increases as the score decreases. The scale ranges from a minimum of 8 to a maximum of 27 points.
Time frame
At 0 minutes after tourniquet removalSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Medipol University Hospital
Lead sponsor
Kartal Dr. Lütfi Kirdar City Hospital
Collaborator
Medipol University
Collaborator
Source ClinicalTrials.gov