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NCT Number: NCT07523958

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lütfi Kırdar City Hospital Istanbul, Turkey

Istanbul, 34760, Turkey (Türkiye)

Location status: Recruiting

Location contact

Müzeyyen Ataseven, PhD, RN

CONTACT

[email protected]

+905052299474

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paraffin Oil

Other

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

Primary outcomes

  1. Incidence of Tourniquet-Related Skin Injury

    Time frame: At 0, 30, and 60 minutes after tourniquet removal

    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.

Secondary outcomes

  1. Severity of Skin Injury

    Time frame: At 0, 30, and 60 minutes after tourniquet removal

    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.

  2. Medical Device-Related Pressure Injury Risk Score

    Time frame: At 0 minutes after tourniquet removal

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muzeyyen Ataseven, PhD, RN

CONTACT

[email protected]

+90 505 229 9474

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital
  • Medipol University

Registry information

Official study title

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

Acronym: PARA-TOUR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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