Environmental Contamination, Microbial Contamination
Conditions
Keywords
Vacuum-assisted electric hair removal system, Surgical site infection, Hair removal, Microbial contamination, Skin integrity
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVacuum-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, microbial contamination (measured by settle plates and sterile swab samples with CFU counts), skin irritation (assessed visually for redness, dryness, and irritation), and patient satisfaction (structured questionnaire). Swab samples will be collected before and after hair removal, environmental contamination will be assessed using petri dishes, and procedure duration will be recorded. All nurses will receive standardized training. Outcome Assessment: Surgical site infection (SSI) will be prospectively
Sponsors
Bilecik Seyh Edebali Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, participants and intervention providers cannot be blinded. However, the statistician performing the data analysis will remain blinded to group allocation. Data will be coded, and the statistician will analyze the outcomes without knowledge of whether participants belong to the intervention or control group.
Intervention model description
The study sample will consist of patients undergoing preoperative hair removal in the surgical area. Participants will be randomly assigned into two groups using block randomization: standard ETM will be used in one group, and VD-ETM in the other. All procedures will be performed in the operating room under the same conditions and using the same type of clipper head. Data will be collected using a demographic form, microbial contamination measurements (CFU via petri dishes and swab samples), skin irritation assessment (visual evaluation), and a patient satisfaction questionnaire. Swab samples will be obtained before and after hair removal, environmental contamination will be measured using petri dishes, and procedure duration will be recorded. Standardization will be ensured by training all practitioner nurses. Surgical site infection will be assessed prospectively on postoperative days 7 and 30 through clinical evaluation and, if necessary, via structured telephone interviews.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial Environmental Contamination | Time Frame: Immediately after completion of the hair removal procedure | Description: Environmental contamination will be measured using settle plates (Petri dishes containing culture medium) placed at standardized distances during preoperative hair removal. Plates will be exposed for 5-10 minutes, incubated at 37 °C for 24-72 hours, and colony-forming units (CFU) will be counted. Additional microbial contamination will be assessed using sterile swab samples collected from a standardized surface area (25×25 cm) before and after hair removal and cultured on agar plates. Measurement Unit: Colony-forming units (CFU/plate and CFU/cm²) |
Countries
Turkey (Türkiye)
Contacts
CONTACTEsma AYDIN
STUDY_DIRECTORDilek AYGİN
Sakarya University
Outcome results
None listed