Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR)

Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Pressure Injury; Skin Lesions; Skin Injury
• Intervention / Treatment: Other: Paraffin Oil

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muzeyyen Ataseven, PhD, RN; Phone Number: +90 505 229 9474; Email: muzeyyenataseven@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34760
    • Recruiting
    • Kartal Dr. Lütfi Kırdar City Hospital Istanbul, Turkey
    • Contact: Müzeyyen Ataseven, PhD, RN; Phone Number: +905052299474; Email: muzeyyenataseven@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paraffin Oil Group; Participants receive topical paraffin oil application before tourniquet placement in addition to routine protective dressing.	Other: Paraffin Oil; Topical paraffin oil is applied to the skin area before tourniquet placement.
No Intervention: Control Group; Participants receive routine protective dressing without paraffin oil application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 0, 30, and 60 minutes after tourniquet removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 0, 30, and 60 minutes after tourniquet removal
Medical Device-Related Pressure Injury Risk Score	Risk of pressure injury associated with medical devices will be assessed using a standardized risk assessment scale immediately after tourniquet removal.	At 0 minutes after tourniquet removal

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: Medipol University; Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Tourniquet; Upper Extremity Surgery; Paraffin Oil; Skin Injury Prevention
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer; Organic Chemicals; Hydrocarbons; Petrolatum; Mineral Oil
• Other Study ID Numbers: TURNIKE-PARAFIN-RCT-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared to protect participant confidentiality and comply with ethical regulations. Data will be used exclusively for the purposes of this study by the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No