Urethral StrictureNCT07508566
A Comparative Study of the Antibacterial Effects of Two Preoperative Hair Removal Methods in Male Patients With Urethral Stricture
A study testing Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG). in people with Urethral Stricture, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Male urethral stricture is one of the common diseases in urology, with risk factors including a history of hypospadias surgery, indwelling urinary catheterization or instrumental manipulation, trauma, transurethral surgery, and prostate cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Aug 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged ≥18 years with a clinically confirmed diagnosis of urethral stricture, who are scheduled to undergo lingual mucosal urethroplasty or end-to-end urethral anastomosis.
- Possess normal cognitive and communication abilities, and be able to cooperate with preoperative cleaning procedures and postoperative follow-up.
- No history of topical antimicrobial therapy on the perineal region before surgery, and no systemic antibiotic administration within 1 week prior to surgery.
- Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Complicated with severe systemic infectious diseases, or suffering from immunodeficiency diseases (e.g., AIDS, long-term use of immunosuppressants).
- Presence of skin damage, ulcers, eczema or other dermatoses on the perineal skin, which may interfere with cleaning procedures and bacterial sample collection.
- A definite history of allergy to chlorhexidine gluconate (CHG) or study-related supplies.
- Having surgical contraindications such as severe hepatic and renal insufficiency, or coagulation dysfunction.
- Inability to cooperate with preoperative cleaning procedures, or failure to complete postoperative follow-up due to personal reasons
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Wei contact
About this study
Male urethral stricture is one of the common diseases in urology, with risk factors including a history of hypospadias surgery, indwelling urinary catheterization or instrumental manipulation, trauma, transurethral surgery, and prostate cancer treatment. Its main clinical manifestations are dysuria, weak urinary stream and frequent micturition, which seriously affect patients' quality of life.
Surgery is the main treatment for moderate to severe urethral stricture. Among various surgical procedures, lingual mucosal urethroplasty and end-to-end urethral anastomosis are widely used in clinical practice due to their high long-term patency rates. However, postoperative complications still plague patients. According to reports, the incidence of urinary tract infection within 30 days after surgery ranges from 6.7% to 21%, and the incidence of surgical site infection (SSI) reaches 4.1%. SSI not only impairs surgical efficacy, but also may prolong hospital stay, increase medical costs and even lead to poor prognosis. As defined by the U.S. Centers for Disease Control and Prevention (CDC), SSI refers to surgery-related infections occurring within 30 days after surgery (or up to 1 year if an implant is present), which are specifically classified into three types: superficial incisional SSI, deep incisional SSI, and organ/space SSI. There are significant regional differences in the global incidence of SSI: it is approximately 2.8% in developed countries, while it can be as high as 22.8% in resource-limited regions, indicating an urgent need to optimize perioperative infection prevention and control strategies.
Read more
The World Health Organization (WHO) has identified standardized preoperative skin preparation as one of the key measures for preventing SSI. The skin is the main source of bacterial colonization in the surgical area. In particular, the perineum, due to its moist environment, numerous folds and easy accumulation of secretions, is prone to becoming a breeding ground for opportunistic pathogens such as Escherichia coli, Klebsiella pneumoniae, Staphylococcus epidermidis and Enterococcus faecalis-all of which are common pathogenic bacteria causing postoperative infections in male patients with urethral stricture.
Effective preoperative skin cleansing can significantly reduce the local microbial load and the risk of intraoperative contamination, thereby lowering the probability of postoperative infection. Therefore, preoperative skin preparation is not only a routine nursing procedure, but also a crucial component of perioperative infection control. Traditional preoperative skin preparation mostly involves wiping with warm water or normal saline, which can remove surface dirt but lacks sustained antibacterial effects and is difficult to effectively inhibit bacterial regrowth. In recent years, chlorhexidine gluconate (CHG) has gradually become the preferred product for preoperative skin disinfection due to its broad-spectrum antibacterial activity, rapid bactericidal effect and persistent residual action. A number of high-quality studies have confirmed that preoperative showering or local wiping with CHG can significantly reduce the incidence of SSI in orthopedic surgery, cesarean section and implantation of cardiac electronic devices.
However, in the field of urology, especially for complex urethral reconstructive surgeries involving the perineal region (such as lingual mucosal urethroplasty and end-to-end urethral anastomosis), studies on the inhibitory effect of local CHG application on skin bacterial colonization and its clinical value remain scarce. Such surgeries are classified as "clean-contaminated" procedures, characterized by long operative time and extensive tissue exposure. In addition, some surgical techniques require tissue harvesting from the oral cavity, which brings the risk of multiple infection sources and imposes higher requirements for aseptic management of the surgical area. Existing studies mostly take postoperative infection rate as the endpoint indicator, and few focus on the impact of preoperative interventions on the dynamic changes of skin microorganisms. Quantitative detection of colony-forming units (CFU) and bacterial species distribution in key anatomical sites can more objectively evaluate the immediate and sustained bacteriostatic effects of different skin preparation methods, thereby revealing their underlying mechanisms of action.
Therefore, this study intends to conduct a prospective research to compare the bacteriostatic effects of different preoperative skin preparation methods in the target population, so as to provide clinical practice with more evidence-based guidelines for perioperative skin preparation procedures.
- Conditions
- Urethral Stricture
- Being tested
- Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG).
- Keywords
- Urethral Stricture, surgical site infection, lingual mucosal urethroplasty, end-to-end urethral anastomosis
- Medical subject headings
- Urethral Stricture, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG).Other
Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG). Frequency and sites of wiping: Twice daily for 3 to 5 days before surgery. The urethral orifice, penis, scrotum and the perineal surrounding skin were disinfected.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG). Frequency and sites of wiping: Twice daily for 3 to 5 days before surgery. The urethral orifice, penis, scrotum and the perineal surrounding skin were disinfected. Receives: Other: Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG). |
| Control group | No intervention | Wiping with a warm water-soaked towel, with the same wiping frequency and sites as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the bacterial load and the identified bacterial species
Sterile cotton swabs moistened with normal saline were used to collect bacterial samples from three sites: the inner surface of the penile foreskin, the penoscrotal junction, and the base of the scrotum. The bacterial load (CFU/cm², a quantitative index expressed as colony-forming units) and the identified bacterial species were recorded.
Measured: Sampling was performed at three time points: before wiping, after wiping (on the morning of the operation day), and on the 3rd postoperative day (when the wound dressing was removed).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong He, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508566
- Sponsor's protocol ID
- 2026-0196
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Antibacterial Effects of Two Preoperative Hair Removal Methods in Male Patients With Urethral Stricture
- ClinicalTrials.gov ID
- NCT07508566
- Acronym / sponsor ID
- 2026-0196
- Conditions
- Urethral Stricture
- Keywords
- Urethral Stricture, surgical site infection, lingual mucosal urethroplasty, end-to-end urethral anastomosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 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.
Male urethral stricture is one of the common diseases in urology, with risk factors including a history of hypospadias surgery, indwelling urinary catheterization or instrumental manipulation, trauma, transurethral surgery, and prostate cancer treatment. Its main clinical manifestations are dysuria, weak urinary stream and frequent micturition, which seriously affect patients' quality of life.
Surgery is the main treatment for moderate to severe urethral stricture. Among various surgical procedures, lingual mucosal urethroplasty and end-to-end urethral anastomosis are widely used in clinical practice due to their high long-term patency rates. However, postoperative complications still plague patients. According to reports, the incidence of urinary tract infection within 30 days after surgery ranges from 6.7% to 21%, and the incidence of surgical site infection (SSI) reaches 4.1%. SSI not only impairs surgical efficacy, but also may prolong hospital stay, increase medical costs and even lead to poor prognosis. As defined by the U.S. Centers for Disease Control and Prevention (CDC), SSI refers to surgery-related infections occurring within 30 days after surgery (or up to 1 year if an implant is present), which are specifically classified into three types: superficial incisional SSI, deep incisional SSI, and organ/space SSI. There are significant regional differences in the global incidence of SSI: it is approximately 2.8% in developed countries, while it can be as high as 22.8% in resource-limited regions, indicating an urgent need to optimize perioperative infection prevention and control strategies.
The World Health Organization (WHO) has identified standardized preoperative skin preparation as one of the key measures for preventing SSI. The skin is the main source of bacterial colonization in the surgical area. In particular, the perineum, due to its moist environment, numerous folds and easy accumulation of secretions, is prone to becoming a breeding ground for opportunistic pathogens such as Escherichia coli, Klebsiella pneumoniae, Staphylococcus epidermidis and Enterococcus faecalis-all of which are common pathogenic bacteria causing postoperative infections in male patients with urethral stricture.
Effective preoperative skin cleansing can significantly reduce the local microbial load and the risk of intraoperative contamination, thereby lowering the probability of postoperative infection. Therefore, preoperative skin preparation is not only a routine nursing procedure, but also a crucial component of perioperative infection control. Traditional preoperative skin preparation mostly involves wiping with warm water or normal saline, which can remove surface dirt but lacks sustained antibacterial effects and is difficult to effectively inhibit bacterial regrowth. In recent years, chlorhexidine gluconate (CHG) has gradually become the preferred product for preoperative skin disinfection due to its broad-spectrum antibacterial activity, rapid bactericidal effect and persistent residual action. A number of high-quality studies have confirmed that preoperative showering or local wiping with CHG can significantly reduce the incidence of SSI in orthopedic surgery, cesarean section and implantation of cardiac electronic devices.
However, in the field of urology, especially for complex urethral reconstructive surgeries involving the perineal region (such as lingual mucosal urethroplasty and end-to-end urethral anastomosis), studies on the inhibitory effect of local CHG application on skin bacterial colonization and its clinical value remain scarce. Such surgeries are classified as "clean-contaminated" procedures, characterized by long operative time and extensive tissue exposure. In addition, some surgical techniques require tissue harvesting from the oral cavity, which brings the risk of multiple infection sources and imposes higher requirements for aseptic management of the surgical area. Existing studies mostly take postoperative infection rate as the endpoint indicator, and few focus on the impact of preoperative interventions on the dynamic changes of skin microorganisms. Quantitative detection of colony-forming units (CFU) and bacterial species distribution in key anatomical sites can more objectively evaluate the immediate and sustained bacteriostatic effects of different skin preparation methods, thereby revealing their underlying mechanisms of action.
Therefore, this study intends to conduct a prospective research to compare the bacteriostatic effects of different preoperative skin preparation methods in the target population, so as to provide clinical practice with more evidence-based guidelines for perioperative skin preparation procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG).Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG). Frequency and sites of wiping: Twice daily for 3 to 5 days before surgery. The urethral orifice, penis, scrotum and the perineal surrounding skin were disinfected. |
| Control group | No intervention | –Wiping with a warm water-soaked towel, with the same wiping frequency and sites as the intervention group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged ≥18 years with a clinically confirmed diagnosis of urethral stricture, who are scheduled to undergo lingual mucosal urethroplasty or end-to-end urethral anastomosis.
- Possess normal cognitive and communication abilities, and be able to cooperate with preoperative cleaning procedures and postoperative follow-up.
- No history of topical antimicrobial therapy on the perineal region before surgery, and no systemic antibiotic administration within 1 week prior to surgery.
- Voluntarily participate in this study and sign the informed consent form.
Key exclusion criteria (5 listed)
- Complicated with severe systemic infectious diseases, or suffering from immunodeficiency diseases (e.g., AIDS, long-term use of immunosuppressants).
- Presence of skin damage, ulcers, eczema or other dermatoses on the perineal skin, which may interfere with cleaning procedures and bacterial sample collection.
- A definite history of allergy to chlorhexidine gluconate (CHG) or study-related supplies.
- Having surgical contraindications such as severe hepatic and renal insufficiency, or coagulation dysfunction.
- Inability to cooperate with preoperative cleaning procedures, or failure to complete postoperative follow-up due to personal reasons
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 |
|---|---|---|
| Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG).Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG). Frequency and sites of wiping: Twice daily for 3 to 5 days before surgery. The urethral orifice, penis, scrotum and the perineal surrounding skin were disinfected. | Other | Intervention group |
Primary outcome
the bacterial load and the identified bacterial species
Time frame: Sampling was performed at three time points: before wiping, after wiping (on the morning of the operation day), and on the 3rd postoperative day (when the wound dressing was removed).
Sterile cotton swabs moistened with normal saline were used to collect bacterial samples from three sites: the inner surface of the penile foreskin, the penoscrotal junction, and the base of the scrotum. The bacterial load (CFU/cm², a quantitative index expressed as colony-forming units) and the identified bacterial species were recorded.
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 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Wei contact
Hong He principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Wiping with wet wipes containing 2% chlorhexidine gluconate (CHG). in people with Urethral Stricture, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 5 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Luopei Wei (0571-56532836, weiluopeiwlp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the bacterial load and the identified bacterial species (time frame: Sampling was performed at three time points: before wiping, after wiping (on the morning of the operation day), and on the 3rd postoperative day (when the wound dressing was removed).). 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 Apr 2026.