Anal Fistula SurgeryNCT06592157
Factors Influencing Wound Healing After Anal Fistula Surgery
An observational study of Anal Fistula Surgery, run by Taichung Veterans General Hospital.
Trial summary
The objective of this observational study is to analyze the factors influencing wound healing after anal fistula surgery and to assess the effectiveness of interventions in improving overall patient outcomes post-surgery. The primary questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula Surgery
- What is being tested?
- NewEpi Plus Liquid Wound Dressing and standard wound care
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing fistula surgery at Taichung Veterans General Hospital.
Who may be able to join
- Patients over 18 years old.
- Have undergone anal fistula surgery with complete surgical records.
- No significant surgical contraindications, such as:Acute infection or inflammation,Severe cardiopulmonary insufficiency,Coagulation disorders,Immunodeficiency,Local skin lesions.
- Understand and are willing to participate in the study.Willing to sign the informed consent form.
Who cannot join
- Patients under 18 years of age.
- Pregnant or breastfeeding women.
- Individuals with pre-existing severe heart, liver, or kidney diseases.
- Individuals with active infections or systemic diseases.
- Individuals who have previously undergone similar surgeries.
- Individuals with immune dysfunction (such as HIV infection).
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this observational study is to analyze the factors influencing wound healing after anal fistula surgery and to assess the effectiveness of interventions in improving overall patient outcomes post-surgery. The primary questions this study aims to answer are:
- Does the use of the growth factor (New Epi) contribute to accelerating wound healing, reducing the risk of infection, and enhancing patient recovery speed after surgery?
- Do other factors, such as infection, nutritional status, diabetes, surgical methods, patient age and overall health, immune status, and lifestyle habits, affect the healing of surgical wounds?
- Conditions
- Anal Fistula Surgery
- Being tested
- NewEpi Plus Liquid Wound Dressing, standard wound care
- Keywords
- Ep ithelial Growth Factor New Epi, Anal Fistula Surgery, Wound Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NewEpi Plus Liquid Wound DressingOther
- Hold the spray nozzle 7-10 cm away from the wound. Apply the product evenly over the wound, with a dosage of one spray (0.1 ml) per 10x10 cm² of wound area.
- Wait for 2 minutes. It is not necessary to wait until the solution is completely dry; you can proceed with applying ointments and various types of dressings as directed by the physician.
- Use once a day for 21 days. The frequency of use can be adjusted according to the physician\'s instructions.
standard wound careOther
The standard wound care protocol aims to provide comprehensive and systematic care for patients to ensure smooth healing of surgical wounds. These care measures include regular cleaning, disinfection, dressing changes, and continuous observation and assessment of the wound condition. Through strict aseptic techniques and scientific care procedures, standard wound care effectively reduces the risk of infection and promotes wound healing.
| Study group | Role | What they receive |
|---|---|---|
| Patients using New Epi epidermal growth factor | Patients using New Epi epidermal growth factor who are over 18 years old, confirmed to require fistula surgery, without significant surgical contraindications, able to understand and willing to participate in the study, and willing to sign the informed consent form. Receives: Other: NewEpi Plus Liquid Wound Dressing | |
| Patients receiving standard wound care | Patients receiving standard wound care who are over 18 years old, confirmed to require fistula surgery, without significant surgical contraindications, able to understand and willing to participate in the study, and willing to sign the informed consent form. Receives: Other: standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Speed
- Description: Wound healing will be assessed using AI-driven models, such as ResNet and EfficientNet, to track the healing process over time. Healing speed will be reported as the percentage of wound closure per day, based on image analysis.
- Unit of Measure: Percentage of wound closure per day (%/day)
Measured: Day 7 and Day 21 after surgery
Postoperative Pain Assessment
- Description: Pain levels will be assessed using the Visual Analog Scale (VAS), where patients rate their pain on a scale of 0 (no pain) to 10 (worst pain). Higher scores indicate worse outcomes.
- Unit of Measure: VAS score (0-10)
Measured: 21 days (approximately three weeks of treatment)
Daily Painkiller Usage
- Description: The number of pain relief medications taken by the patient each day will be recorded. This measure will assess the level of pain management required post-surgery. A higher number of painkillers used indicates more pain or less effective pain control.
- Unit of Measure: Number of painkillers per day
Measured: 21 days (approximately three weeks of treatment)
Complication Rate
- Description: The incidence of complications, such as infection, bleeding, or wound dehiscence, will be tracked. The number of participants experiencing any complications will be reported.
- Unit of Measure: Number of participants
Measured: 21 days (approximately three weeks of treatment)
Secondary outcomes (13)
Number of Participants Who Smoke
- Description: Smoking status will be recorded for all participants, categorizing them as current smokers, former smokers, or non-smokers. This will help assess whether smoking affects wound healing outcomes.
- Unit of Measure: Number of participants
Measured: At baseline (pre-surgery)
Number of Participants with Alcohol Consumption
- Description: Alcohol consumption will be documented, with participants categorized based on their usage patterns (e.g., none, occasional, or frequent use). This measure will examine any correlation between alcohol use and wound healing.
- Unit of Measure: Number of participants
Measured: At baseline (pre-surgery)
Dietary Habits
- Description:By recording dietary habits (vegetarian or non-vegetarian; dining out or home-cooked meals), we aim to determine whether diet affects the healing of surgical wounds.
- Unit of Measure: Number of participants
Measured: At baseline (pre-surgery)
Sleep Patterns
- Description: By recording sleep times (before 10 PM, 10 PM to midnight, midnight to 2 AM, after 2 AM), we aim to determine whether sleep patterns affect the healing of surgical wounds.
- Unit of Measure: Number of participants
Measured: 21 days (approximately three weeks of treatment)
Nutritional Status
- Description: Nutritional status will be assessed by tracking recent weight loss (more than 5% after surgry 3 weeks). This will evaluate the potential impact of poor nutrition on wound healing.
- Unit of Measure: Number of participants
Measured: 21 days (approximately three weeks of treatment)
HbA1C Levels to Assess Diabetes Control
- Description: HbA1C levels will be measured to evaluate diabetes control and its influence on postoperative wound healing.
- Unit of Measure: HbA1C (%)
Measured: 21 days (approximately three weeks of treatment)
BUN levels
- Description: The study will assess whether blood urea nitrogen (BUN) levels, measured through blood tests, have an impact on wound healing.
- Unit of Measure: BUN (mg/dL)
Measured: At baseline and Day 21 after surgery
eGFR values
- The study will evaluate whether glomerular filtration rate (eGFR) values, assessed through blood tests, influence wound healing.
- Unit of Measure: eGFR (mL/min/1.73 m²)
Measured: At baseline and Day 21 after surgery
creatinine levels
- The study will assess whether creatinine levels, evaluated through blood tests, have an impact on wound healing.
- Unit of Measure: creatinine (mg/dL)
Measured: At baseline and Day 21 after surgery
AST (SGOT) levels
- Description: Liver function will be assessed by measuring AST (SGOT) . This evaluation will help determine whether liver function impacts wound healing.
- Unit of Measure: U/L
Measured: At baseline and Day 21 after surgery
ALT (SGPT) levels
- Description: Liver function will be assessed by measuring ALT (SGPT) . This evaluation will help determine whether liver function impacts wound healing.
- Unit of Measure: U/L
Measured: At baseline and Day 21 after surgery
Total Bilirubin levels
- Description: Liver function will be assessed by measuring Total Bilirubin. This evaluation will help determine whether liver function impacts wound healing.
- Unit of Measure:mg/dL
Measured: At baseline and Day 21 after surgery
Direct Bilirubin levels
1.Description: Liver function will be assessed by measuring Direct Bilirubin. This evaluation will help determine whether liver function impacts wound healing. 2. Unit of Measure:mg/dL
Measured: At baseline and Day 21 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Fistula SurgeryStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592157
- Sponsor's protocol ID
- CG24317B
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Wound Healing After Anal Fistula Surgery
- ClinicalTrials.gov ID
- NCT06592157
- Acronym / sponsor ID
- CG24317B
- Conditions
- Anal Fistula Surgery
- Keywords
- Ep ithelial Growth Factor New Epi, Anal Fistula Surgery, Wound Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The objective of this observational study is to analyze the factors influencing wound healing after anal fistula surgery and to assess the effectiveness of interventions in improving overall patient outcomes post-surgery. The primary questions this study aims to answer are:
- Does the use of the growth factor (New Epi) contribute to accelerating wound healing, reducing the risk of infection, and enhancing patient recovery speed after surgery?
- Do other factors, such as infection, nutritional status, diabetes, surgical methods, patient age and overall health, immune status, and lifestyle habits, affect the healing of surgical wounds?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients using New Epi epidermal growth factor | – | Other: NewEpi Plus Liquid Wound DressingPatients using New Epi epidermal growth factor who are over 18 years old, confirmed to require fistula surgery, without significant surgical contraindications, able to understand and willing to participate in the study, and willing to sign the informed consent form. |
| Patients receiving standard wound care | – | Other: standard wound carePatients receiving standard wound care who are over 18 years old, confirmed to require fistula surgery, without significant surgical contraindications, able to understand and willing to participate in the study, and willing to sign the informed consent form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing fistula surgery at Taichung Veterans General Hospital.
Key inclusion criteria (4 listed)
- Patients over 18 years old.
- Have undergone anal fistula surgery with complete surgical records.
- No significant surgical contraindications, such as:Acute infection or inflammation,Severe cardiopulmonary insufficiency,Coagulation disorders,Immunodeficiency,Local skin lesions.
- Understand and are willing to participate in the study.Willing to sign the informed consent form.
Key exclusion criteria (6 listed)
- Patients under 18 years of age.
- Pregnant or breastfeeding women.
- Individuals with pre-existing severe heart, liver, or kidney diseases.
- Individuals with active infections or systemic diseases.
- Individuals who have previously undergone similar surgeries.
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 |
|---|---|---|
| NewEpi Plus Liquid Wound Dressing1. Hold the spray nozzle 7-10 cm away from the wound. Apply the product evenly over the wound, with a dosage of one spray (0.1 ml) per 10x10 cm² of wound area. 2. Wait for 2 minutes. It is not necessary to wait until the solution is completely dry; you can proceed with applying ointments and various types of dressings as directed by the physician. 3. Use once a day for 21 days. The frequency of use can be adjusted according to the physician\'s instructions. | Other | Patients using New Epi epidermal growth factor |
| standard wound careThe standard wound care protocol aims to provide comprehensive and systematic care for patients to ensure smooth healing of surgical wounds. These care measures include regular cleaning, disinfection, dressing changes, and continuous observation and assessment of the wound condition. Through strict aseptic techniques and scientific care procedures, standard wound care effectively reduces the risk of infection and promotes wound healing. | Other | Patients receiving standard wound care |
Primary outcome
Wound Healing Speed
Time frame: Day 7 and Day 21 after surgery
1. Description: Wound healing will be assessed using AI-driven models, such as ResNet and EfficientNet, to track the healing process over time. Healing speed will be reported as the percentage of wound closure per day, based on image analysis. 2. Unit of Measure: Percentage of wound closure per day (%/day)
Postoperative Pain Assessment
Time frame: 21 days (approximately three weeks of treatment)
1. Description: Pain levels will be assessed using the Visual Analog Scale (VAS), where patients rate their pain on a scale of 0 (no pain) to 10 (worst pain). Higher scores indicate worse outcomes. 2. Unit of Measure: VAS score (0-10)
Daily Painkiller Usage
Time frame: 21 days (approximately three weeks of treatment)
1. Description: The number of pain relief medications taken by the patient each day will be recorded. This measure will assess the level of pain management required post-surgery. A higher number of painkillers used indicates more pain or less effective pain control. 2. Unit of Measure: Number of painkillers per day
Complication Rate
Time frame: 21 days (approximately three weeks of treatment)
1. Description: The incidence of complications, such as infection, bleeding, or wound dehiscence, will be tracked. The number of participants experiencing any complications will be reported. 2. Unit of Measure: Number of participants
13 secondary outcomes
Number of Participants Who Smoke
Time frame: At baseline (pre-surgery)
Number of Participants with Alcohol Consumption
Time frame: At baseline (pre-surgery)
Dietary Habits
Time frame: At baseline (pre-surgery)
Sleep Patterns
Time frame: 21 days (approximately three weeks of treatment)
Nutritional Status
Time frame: 21 days (approximately three weeks of treatment)
HbA1C Levels to Assess Diabetes Control
Time frame: 21 days (approximately three weeks of treatment)
BUN levels
Time frame: At baseline and Day 21 after surgery
eGFR values
Time frame: At baseline and Day 21 after surgery
creatinine levels
Time frame: At baseline and Day 21 after surgery
AST (SGOT) levels
Time frame: At baseline and Day 21 after surgery
ALT (SGPT) levels
Time frame: At baseline and Day 21 after surgery
Total Bilirubin levels
Time frame: At baseline and Day 21 after surgery
Direct Bilirubin levels
Time frame: At baseline and Day 21 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula Surgery, run by Taichung Veterans General Hospital.
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 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yu Lin, PhD (886-4-23592525 ext. 5162, classicpiano2003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Speed (time frame: Day 7 and Day 21 after surgery). The study lists 4 primary outcomes in all. 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 19 Sep 2024.