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NCT Number: NCT07155356

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

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.

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Key information

Conditions

Perianal Abscess Erythema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Putian University

Putian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Red light exposure

Device

Patients in the red light group received red light therapy concurrently with standard care.

Red-blue light exposure

Device

Patients in the red and blue light group received combined red and blue light therapy concurrently with standard care。

Primary outcomes

  1. Wound healing time

    Time frame: Measurements were taken over a time frame of 24 hours postoperatively to complete epithelialisation.

    Defined as 100% re-epithelialization assessed by blinded evaluator.

Secondary outcomes

  1. Postoperative pain intensity

    Time frame: Baseline, Day 1, 3, 5, 7, and Day 14±2

    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."

  2. Peripheral tissue edema（Grade 0-3）

    Time frame: Day 1, 3, 5, 7, and Day 14±2

    • 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.

  3. Assessment of Granulation Tissue in Wound Bed

    Time frame: Day 1, 3, 5, 7, and Day 14±2

    • 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.

  4. Length of hospital stay

    Time frame: From surgery end to discharge (up to 7 days)

    Measured in hours with standardized discharge criteria.

  5. Complication incidence

    Time frame: Within 30 days postoperatively

    Measurements include the incidence of postoperative bleeding, urinary retention, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenxing C Jian

CONTACT

[email protected]

+8613959538950

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Putian University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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