An interventional study of Paraffin Oil in Pressure Injury, Skin Lesions and Skin Injury, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Prevention
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.
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.
IInclusion Criteria:
Exclusion Criteria:
Participants receive topical paraffin oil application before tourniquet placement in addition to routine protective dressing.
Other: Paraffin Oil
Participants receive routine protective dressing without paraffin oil application.
Topical paraffin oil is applied to the skin area before tourniquet placement.
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 removal
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 removal
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 removal
Plan to share: No — 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.
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Istanbul Medipol University Hospital