Factors Influencing Wound Healing After Anal Fistula Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NewEpi Plus Liquid Wound Dressing, standard wound care.
- Who it may be relevant to
- Registry conditions: Anal Fistula Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Interventions
- Other 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. - 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.
Primary outcome measures
- Wound Healing Speed [Time frame: Day 7 and Day 21 after surgery]
- Postoperative Pain Assessment [Time frame: 21 days (approximately three weeks of treatment)]
- Daily Painkiller Usage [Time frame: 21 days (approximately three weeks of treatment)]
- Complication Rate [Time frame: 21 days (approximately three weeks of treatment)]
Secondary outcome measures (12)
- 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]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06592157 · CG24317B