Factors Influencing Wound Healing After Anal Fistula Surgery | NCT06592157

NCT06592157

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NewEpi Plus Liquid Wound Dressing	Other	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. 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. Use once a day for 21 days. The frequency of use can be adjusted according to the physician's instructions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound Healing Speed	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. Unit of Measure: Percentage of wound closure per day (%/day)	Day 7 and Day 21 after surgery
Postoperative Pain Assessment	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. Unit of Measure: VAS score (0-10)	21 days (approximately three weeks of treatment)
Daily Painkiller Usage	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. Unit of Measure: Number of painkillers per day	21 days (approximately three weeks of treatment)
Complication Rate	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. Unit of Measure: Number of participants	21 days (approximately three weeks of treatment)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Smoke	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. Unit of Measure: Number of participants	At baseline (pre-surgery)

Eligibility Module

Name	Role	Phone	Extension	Email
Chun-Yu Lin, PhD	Contact	886-4-23592525	5162	classicpiano2003@gmail.com

IPD Sharing Statement Module