Factors Influencing Wound Healing After Anal Fistula Surgery

Not yet recruiting

• Conditions: Anal Fistula Surgery
• Interventions: Other: NewEpi Plus Liquid Wound Dressing; Other: standard wound care

• Registration Number: NCT06592157
• Lead Sponsor: Taichung Veterans General Hospital

Brief 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. 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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-08
• Last Update Submitted: 2024-09-08
• Study Start: 2024-09-10
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients using New Epi epidermal growth factor	NewEpi Plus Liquid Wound Dressing	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.
Patients receiving standard wound care	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.

Primary Outcome Measures

Name	Time	Method
Wound Healing Speed	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Smoke	At baseline (pre-surgery)	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
Number of Participants with Alcohol Consumption	At baseline (pre-surgery)	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
Dietary Habits	At baseline (pre-surgery)	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
Sleep Patterns	21 days (approximately three weeks of treatment)	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
Nutritional Status	21 days (approximately three weeks of treatment)	1. 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.; 2. Unit of Measure: Number of participants
HbA1C Levels to Assess Diabetes Control	21 days (approximately three weeks of treatment)	1. Description: HbA1C levels will be measured to evaluate diabetes control and its influence on postoperative wound healing.; 2. Unit of Measure: HbA1C (%)
BUN levels	At baseline and Day 21 after surgery	1. Description: The study will assess whether blood urea nitrogen (BUN) levels, measured through blood tests, have an impact on wound healing.; 2. Unit of Measure: BUN (mg/dL)
eGFR values	At baseline and Day 21 after surgery	1. The study will evaluate whether glomerular filtration rate (eGFR) values, assessed through blood tests, influence wound healing.; 2. Unit of Measure: eGFR (mL/min/1.73 m²)
creatinine levels	At baseline and Day 21 after surgery	1. The study will assess whether creatinine levels, evaluated through blood tests, have an impact on wound healing.; 2. Unit of Measure: creatinine (mg/dL)
AST (SGOT) levels	At baseline and Day 21 after surgery	1. Description: Liver function will be assessed by measuring AST (SGOT) . This evaluation will help determine whether liver function impacts wound healing.; 2. Unit of Measure: U/L
ALT (SGPT) levels	At baseline and Day 21 after surgery	1. Description: Liver function will be assessed by measuring ALT (SGPT) . This evaluation will help determine whether liver function impacts wound healing.; 2. Unit of Measure: U/L
Total Bilirubin levels	At baseline and Day 21 after surgery	1. Description: Liver function will be assessed by measuring Total Bilirubin. This evaluation will help determine whether liver function impacts wound healing.; 2. Unit of Measure:mg/dL
Direct Bilirubin levels	At baseline and Day 21 after surgery	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