Factors Influencing Wound Healing After Anal Fistula Surgery
ConditionAnal Fistula Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital
About this trial
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. 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? 2. 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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients undergoing fistula surgery at Taichung Veterans General Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NewEpi Plus Liquid Wound Dressing
Other intervention1. 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.
standard wound care
Other interventionThe 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Patients using New Epi epidermal growth factor1 intervention
Group B: Patients receiving standard wound care1 intervention
Trial outcomes
Primary outcomes
1
Wound Healing Speed
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)
Time frame
Day 7 and Day 21 after surgery2
Postoperative Pain Assessment
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)
Time frame
21 days (approximately three weeks of treatment)3
Daily Painkiller Usage
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
Time frame
21 days (approximately three weeks of treatment)4
Complication Rate
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
Time frame
21 days (approximately three weeks of treatment)Secondary outcomes
1
Number of Participants Who Smoke
1. 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. 2. Unit of Measure: Number of participants
Time frame
At baseline (pre-surgery)2
Number of Participants with Alcohol Consumption
1. 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. 2. Unit of Measure: Number of participants
Time frame
At baseline (pre-surgery)3
Dietary Habits
1. 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. 2. Unit of Measure: Number of participants
Time frame
At baseline (pre-surgery)4
Sleep Patterns
1. 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. 2. Unit of Measure: Number of participants
Time frame
21 days (approximately three weeks of treatment)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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