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

NCT07155356 — Not applicable, Not yet recruiting, 222 participants, The Affiliated Hospital of Putian University

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

Registry	NCT07155356
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	222 (Estimated)
Sponsor	The Affiliated Hospital of Putian University (Other)
Conditions	Perianal Abscess
Interventions	Red light exposure, Red-blue light exposure (Device)
Dates	start 2025-09-15 (estimated), primary completion 2026-08-14 (estimated), completion 2026-09-30 (estimated), first posted 2025-09-04, last updated 2025-09-04
Locations	1 site in China

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
control group	No intervention		Routine care of patients after surgery for perianal abscesses.
Red Ligh Group	Experimental	Device: Red light exposure	Postoperative care of patients with perianal abscesses using routine plus red light irradiation.
Combined Red-Blue Light Group	Experimental	Device: Red-blue light exposure	Use of routine plus red and blue light in postoperative care of patients with perianal abscesses.

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。

+Outcome measures

Primary outcomes

Wound healing time [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

Postoperative pain intensity [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."
Peripheral tissue edema（Grade 0-3） [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.
Assessment of Granulation Tissue in Wound Bed [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.
Length of hospital stay [From surgery end to discharge (up to 7 days)]: Measured in hours with standardized discharge criteria.
Complication incidence [Within 30 days postoperatively]: Measurements include the incidence of postoperative bleeding, urinary retention, etc.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (1)

Facility	City	Country	Status
Affiliated Hospital of Putian University	Putian	China

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