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The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization

The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization

Recruiting
18-43 years
Female
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Infertility

NCT06319573

Ginefiv

13 May 2026

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FAQs

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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