Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery

NCT07523958 | Recruiting

• 1 other identifier: TURNIKE-PARAFIN-RCT-2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Injury; Skin Lesions; Skin Injury

Keywords

Paraffin Oil; Tourniquet; Upper Extremity Surgery; Skin Injury Prevention; Randomized Controlled Trial

Outcome Measures

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.

  At 0, 30, and 60 minutes after tourniquet removal

Secondary Outcomes (2)

• Severity of Skin Injury

  At 0, 30, and 60 minutes after tourniquet removal

• Medical Device-Related Pressure Injury Risk Score

  At 0 minutes after tourniquet removal

Study Arms (2)

Paraffin Oil Group

EXPERIMENTAL

Participants receive topical paraffin oil application before tourniquet placement in addition to routine protective dressing.

Other: Paraffin Oil

Control Group

NO INTERVENTION

Participants receive routine protective dressing without paraffin oil application.

Interventions

Paraffin Oil OTHER

Topical paraffin oil is applied to the skin area before tourniquet placement.

Paraffin Oil Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Kartal Dr. Lütfi Kirdar City Hospital: collaborator
• Medipol University: collaborator

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital Istanbul, Turkey

Istanbul, 34760, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Mineral Oil

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Petrolatum; Hydrocarbons; Organic Chemicals

Central Study Contacts

Muzeyyen Ataseven, PhD, RN

CONTACT

+90 505 229 9474; muzeyyenataseven@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician responsible for data analysis will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Assistant Professor

Model Details: Participants will be randomly assigned to either an intervention group receiving topical paraffin oil application in addition to routine care or a control group receiving routine care only in a parallel design.

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: January 12, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)