Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity

Официальное название

An Evaluation of the Effects of Using a Vacuum-Assisted Electric Shaver for Preoperative Hair Removal on Microbial Environmental Contamination and the Skin

Обзор

This randomized controlled study aims to evaluate the effectiveness of a vacuum-assisted electric trimmer (VD-ETM) compared with a standard electric trimmer (ETM) for preoperative hair removal. The study will assess microbial and environmental contamination, surgical site infection (SSI), procedure duration, skin integrity, patient safety, and patient satisfaction. Preoperative hair removal is a critical step in preventing SSI; however, conventional ETM devices may contribute to environmental contamination due to dispersed hair particles. VD-ETM systems are designed to reduce this risk by simultaneously removing hair and capturing particles. This study will provide evidence on whether VD-ETM improves operating room hygiene and patient outcomes.

Подробное описание

This study is designed as a randomized controlled trial to evaluate the effectiveness of a vacuum-assisted electric trimmer (VD-ETM) compared with a standard electric trimmer (ETM) for preoperative hair removal. The primary focus is to assess microbial and environmental contamination associated with each method, as well as their impact on surgical site infection (SSI), skin integrity, procedure duration, and patient-related outcomes. Participants will be randomly assigned to the intervention (VD-ETM) or control (ETM) group using block randomization via an online randomization tool. All procedures will be performed preoperatively in the operating room under standardized conditions to ensure consistency between groups. Data collection will include demographic and clinical characteristics, microbial contamination (measured as colony-forming units \[CFU\] from settle plates and skin swab samples), environmental contamination, skin irritation (assessed by visual inspection), and patient satisfaction (evaluated using a structured questionnaire). Swab samples will be collected before and after hair removal, and procedure duration will be recorded. All practitioners will receive standardized training. Surgical site infection (SSI) will be assessed prospectively on postoperative days 7 and 30 through clinical evaluation and, when necessary, structured telephone follow-up. This study is expected to provide evidence-based data to improve preoperative hair removal practices, enhance patient and staff safety, and support evidence-based nursing interventions in surgical care.

Вмешательства

• Устройство Vacuum-Assisted Electric Shaver (VD-ETM) Method
  The study population will consist of patients requiring preoperative hair removal at the surgical site. Participants will be randomly assigned into two groups using block randomization: standard electric trimmer (ETM) or vacuum-assisted electric trimmer (VD-ETM). All procedures will be performed preoperatively in the operating room under standardized conditions, using the same boundaries and clipper head type. Data Collection: Data will include demographic and clinical characteristics, microbi

Первичные конечные точки

• Microbial Environmental Contamination [Срок оценки: Time Frame: Immediately after completion of the hair removal procedure]

Критерии участия

Критерии включения

• Male patients aged 18 years and older
• Scheduled for elective laparoscopic surgery
• Require preoperative hair removal at the surgical site
• Classified as ASA I, ASA II, or ASA III
• Able and willing to provide written informed consent

Критерии исключения

• Female patients
• Patients who do not require preoperative hair removal
• ASA IV or higher risk classification
• Presence of active skin lesions at the surgical site that may affect assessment (e.g., dermatitis, psoriasis, open wounds, prominent scars, recent sunburn)
• Use of any of the following within the last 7 days:
• Antimicrobial soap, lotion, or shampoo
• Topical or systemic antibiotics
• Steroid therapy
• Exposure to biocide-containing pools or thermal/spa waters
• Severe immunosuppression (e.g., absolute neutropenia, high-dose steroid therapy)
• Requirement for emergency surgery
• Known allergy to any products or procedures used in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Bilecik Şeyh Edebali Üniversitesi — Bilecik

Идентификаторы

NCT: NCT07517341 · BilecikSeyhEU-CHH-EA-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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