Pressure InjuryPARA-TOURNCT07523958
Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery
A study testing Paraffin Oil in people with Pressure Injury and Skin Lesions, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Skin Lesions, Skin Injury
- What is being tested?
- Paraffin Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kartal Dr. Lütfi Kırdar City Hospital Istanbul, Turkey
Istanbul, 34760
Müzeyyen Ataseven, PhD, RN, +905052299474, muzeyyenataseven@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pressure Injury, Skin Lesions, Skin Injury
- Being tested
- Paraffin Oil
- Keywords
- Paraffin Oil, Tourniquet, Upper Extremity Surgery, Skin Injury Prevention, Randomized Controlled Trial
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraffin OilOther
Topical paraffin oil is applied to the skin area before tourniquet placement.
| Study group | Role | What they receive |
|---|---|---|
| Paraffin Oil Group | Experimental | Participants receive topical paraffin oil application before tourniquet placement in addition to routine protective dressing. Receives: Other: Paraffin Oil |
| Control Group | No intervention | Participants receive routine protective dressing without paraffin oil application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 0, 30, and 60 minutes after tourniquet removal
Secondary outcomes (2)
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.
Measured: 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.
Measured: At 0 minutes after tourniquet removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start12 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital, Medipol University
- Responsible party
- Principal investigator, muzeyyen ataseven, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523958
- Sponsor's protocol ID
- TURNIKE-PARAFIN-RCT-2026
- Acronym
- PARA-TOUR
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR RCT)
- ClinicalTrials.gov ID
- NCT07523958
- Acronym / sponsor ID
- PARA-TOUR / TURNIKE-PARAFIN-RCT-2026
- Conditions
- Pressure Injury, Skin Lesions, Skin Injury
- Keywords
- Paraffin Oil, Tourniquet, Upper Extremity Surgery, Skin Injury Prevention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital, Medipol University
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paraffin Oil Group | Experimental | Other: Paraffin OilParticipants receive topical paraffin oil application before tourniquet placement in addition to routine protective dressing. |
| Control Group | No intervention | –Participants receive routine protective dressing without paraffin oil application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraffin OilTopical paraffin oil is applied to the skin area before tourniquet placement. | Other | Paraffin Oil Group |
Primary outcome
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.
2 secondary outcomes
Severity of Skin Injury
Time frame: At 0, 30, and 60 minutes after tourniquet removal
Medical Device-Related Pressure Injury Risk Score
Time frame: At 0 minutes after tourniquet removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin Oil in people with Pressure Injury and Skin Lesions, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muzeyyen Ataseven, PhD, RN (+90 505 229 9474, muzeyyenataseven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Tourniquet-Related Skin Injury (time frame: At 0, 30, and 60 minutes after tourniquet removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.