Factors Influencing Wound Healing After Anal Fistula Surgery

NCT06592157 | Not Yet Recruiting DMC

• 1 other identifier: CG24317B
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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. 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. 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?

Conditions

Anal Fistula Surgery

Keywords

Ep ithelial Growth Factor New Epi; Anal Fistula Surgery; Wound Care

Outcome Measures

Primary Outcomes (4)

• 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)

  Day 7 and Day 21 after surgery

• 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)

  21 days (approximately three weeks of treatment)

• 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

  21 days (approximately three weeks of treatment)

• 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

  21 days (approximately three weeks of treatment)

Secondary Outcomes (13)

• Number of Participants Who Smoke

  At baseline (pre-surgery)

• Number of Participants with Alcohol Consumption

  At baseline (pre-surgery)

• Dietary Habits

  At baseline (pre-surgery)

• Sleep Patterns

  21 days (approximately three weeks of treatment)

• Nutritional Status

  21 days (approximately three weeks of treatment)

Study Arms (2)

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.

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.

Other: standard wound care

Interventions

NewEpi Plus Liquid Wound Dressing OTHER

1. 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.

Patients using New Epi epidermal growth factor

standard wound care OTHER

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.

Patients receiving standard wound care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing fistula surgery at Taichung Veterans General Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Central Study Contacts

Chun-Yu Lin, PhD

CONTACT

886-4-23592525; classicpiano2003@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 2024/9\~2026/6
• Access Criteria: 1. Access Personnel: Internal research team members, limited to authorized personnel involved in the research project, such as the principal investigator, data analysts, and clinically relevant physicians. 2. Access Content: Patient data, including age, gender, medical history, treatment details, and follow-up data. 3. Access Method: Data will be accessed through a secure network system or database, requiring individual authorization and password protection. All individuals or teams accessing the data must sign a confidentiality agreement.