Microbial ContaminationNCT07517341
Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
A study testing Vacuum-Assisted Electric Shaver (VD-ETM) Method in people with Microbial Contamination and Environmental Contamination, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Microbial Contamination, Environmental Contamination
- What is being tested?
- Vacuum-Assisted Electric Shaver (VD-ETM) Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 30 Dec 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
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
Bilecik Şeyh Edebali Üniversitesi
Bilecik, Merkez, 11100
About this study
Official title: An Evaluation of the Effects of Using a Vacuum-Assisted Electric Shaver for Preoperative Hair Removal on Microbial Environmental Contamination and the Skin
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.
Read the 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.
- Being tested
- Vacuum-Assisted Electric Shaver (VD-ETM) Method
- Keywords
- Vacuum-assisted electric hair removal system, Surgical site infection, Hair removal, Microbial contamination, Skin integrity
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-Assisted Electric Shaver (VD-ETM) MethodDevice
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
| Study group | Role | What they receive |
|---|---|---|
| müdahale kolu | Experimental | 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 Receives: Device: Vacuum-Assisted Electric Shaver (VD-ETM) Method |
| kontrol grubu | No intervention | No interventions will be performed on the control group by the researcher; the institution's standard protocol will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Environmental Contamination
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)
Measured: Time Frame: Immediately after completion of the hair removal procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ContaminationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Aydın, Bilecik Seyh Edebali Universitesi
- Investigators
- Dilek AYGİN, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517341
- Sponsor's protocol ID
- BilecikSeyhEU-CHH-EA-01
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effects of Using a Vacuum-Assisted Electric Shaver for Preoperative Hair Removal on Microbial Environmental Contamination and the Skin
- ClinicalTrials.gov ID
- NCT07517341
- Acronym / sponsor ID
- BilecikSeyhEU-CHH-EA-01
- Keywords
- Vacuum-assisted electric hair removal system, Surgical site infection, Hair removal, Microbial contamination, Skin integrity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| müdahale kolu | Experimental | Device: Vacuum-Assisted Electric Shaver (VD-ETM) MethodThe 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 |
| kontrol grubu | No intervention | –No interventions will be performed on the control group by the researcher; the institution's standard protocol will be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
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 |
|---|---|---|
| Vacuum-Assisted Electric Shaver (VD-ETM) MethodThe 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 | Device | müdahale kolu |
Primary outcome
Microbial Environmental Contamination
Time frame: 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)
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 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Dilek AYGİN study director
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-Assisted Electric Shaver (VD-ETM) Method in people with Microbial Contamination and Environmental Contamination, run by Bilecik Seyh Edebali Universitesi 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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Oct 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 Esma AYDIN (+905316901620, esma.aydin@bilecik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Environmental Contamination (time frame: Time Frame: Immediately after completion of the hair removal procedure). 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 2 Oct 2026.