Effect of Red and Blue Light Irradiation on Postoperative Wound Healing in Perianal Absces

Effect of Red and Blue Light Irradiation on Postoperative Wound Healing in Perianal Abscess: a Single-center Prospective Open-label Randomized Clinical Trial

This study aims to investigate whether specialized red-blue light irradiation facilitates faster postoperative recovery and reduces complication rates in patients following perianal abscess surgery. A total of 222 eligible patients were randomly allocated equally into three groups (74 per group):①Routine Care Group: Standard wound care including cleansing and dressing changes；②Red Light Therapy Group: Routine care plus red light phototherapy；③Combined Red-Blue Light Therapy Group: Routine care plus concurrent red and blue light phototherapy.Wound healing time and incidence of complications were compared to assess postoperative recovery across interventions. The primary hypothesis posits that adjunctive phototherapy-particularly combined red-blue light irradiation-will significantly enhance wound healing, reduce edema and pain, and decrease complication rates (e.g.bleeding, urinary retention) compared to routine care alone.

Study Overview

• Status: Not yet recruiting
• Conditions: Perianal Abscess
• Intervention / Treatment: Device: Red light exposure; Device: Red-blue light exposure

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chenxing C Jian; Phone Number: +8613959538950; Email: ptyyjcx@126.com

Study Locations

• China
  • Putian, China
    • Affiliated Hospital of Putian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged between 18 and 75 years;
• Clinical diagnosis of perianal abscess；
• Procedure: Radical resection with incision and drainage.

Exclusion Criteria:

• Concurrent anorectal disorders (hemorrhoids, anal fissure) or malignancies/infectious diseases；
• History of psychiatric disorders；
• Analgesic use within 7 days preoperatively；
• Coagulopathy or cardiac/hepatic dysfunction；
• Pregnancy or lactation；
• Contraindications to phototherapy；
• IBD-related perianal abscess.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Routine care of patients after surgery for perianal abscesses.
Experimental: Red Ligh Group; Postoperative care of patients with perianal abscesses using routine plus red light irradiation.	Device: Red light exposure; Patients in the red light group received red light therapy concurrently with standard care.
Experimental: Combined Red-Blue Light Group; Use of routine plus red and blue light in postoperative care of patients with perianal abscesses.	Device: Red-blue light exposure; Patients in the red and blue light group received combined red and blue light therapy concurrently with standard care。

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing time	Defined as 100% re-epithelialization assessed by blinded evaluator.	Measurements were taken over a time frame of 24 hours postoperatively to complete epithelialisation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	Assessed at rest and during defecation.Numerical Rating Scale will be used,patients are asked to choose a whole number (integer) from 0 to 10 that best describes their pain.0 usually means "no pain."10 means "the worst pain imaginable."	Baseline, Day 1, 3, 5, 7, and Day 14±2
Peripheral tissue edema（Grade 0-3）	Grade 0 (None): No edema.; Grade 1 (Mild): Mild edema with slight swelling around the incision; skin folds remain clearly visible.; Grade 2 (Moderate): Moderate edema with pronounced swelling around the incision; skin folds are indistinct.; Grade 3 (Severe): Severe edema with marked swelling around the incision; skin folds are obliterated.	Day 1, 3, 5, 7, and Day 14±2
Assessment of Granulation Tissue in Wound Bed	Grade 0 (Absent): No granulation tissue present.; Grade 1 (Poor): Minimal, pale, and friable granulation tissue with easy bleeding.; Grade 2 (Fair): Moderate amount of granulation tissue; pinkish-red in color but remains somewhat friable.; Grade 3 (Good): Healthy, abundant granulation tissue filling the wound bed; beefy red in color and firm to the touch, with minimal bleeding.	Day 1, 3, 5, 7, and Day 14±2
Length of hospital stay	Measured in hours with standardized discharge criteria.	From surgery end to discharge (up to 7 days)
Complication incidence	Measurements include the incidence of postoperative bleeding, urinary retention, etc.	Within 30 days postoperatively

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Putian University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 31, 2025
• First Submitted That Met QC Criteria: September 1, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: wound healing; perianal abscess; red light phototherapy; red and blue light phototherapy
• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Erythema
• Other Study ID Numbers: AHPutianU-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No