Factors Influencing Wound Healing After Anal Fistula Surgery

NCT ID: NCT06592157

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-06-30

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?

Conditions

Anal Fistula Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

NewEpi Plus Liquid Wound Dressing

Intervention Type: 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 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.

standard wound care

Intervention Type: 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.

Interventions

NewEpi Plus Liquid Wound Dressing

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.

Intervention Type: OTHER

standard wound care

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chun-Yu Lin, PhD

Role: CONTACT

classicpiano2003@gmail.com

886-4-23592525 ext. 5162

Other Identifiers

CG24317B

Identifier Type: -

Identifier Source: org_study_id