NCT07155356

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

July 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

July 31, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

perianal abscessred light phototherapyred and blue light phototherapywound healing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Postoperative pain intensity

    Baseline, Day 1, 3, 5, 7, and Day 14±2

  • Peripheral tissue edema(Grade 0-3)

    Day 1, 3, 5, 7, and Day 14±2

  • Assessment of Granulation Tissue in Wound Bed

    Day 1, 3, 5, 7, and Day 14±2

  • Length of hospital stay

    From surgery end to discharge (up to 7 days)

  • Complication incidence

    Within 30 days postoperatively

Study Arms (3)

control group

NO INTERVENTION

Routine care of patients after surgery for perianal abscesses.

Red Ligh Group

EXPERIMENTAL

Postoperative care of patients with perianal abscesses using routine plus red light irradiation.

Device: Red light exposure

Combined Red-Blue Light Group

EXPERIMENTAL

Use of routine plus red and blue light in postoperative care of patients with perianal abscesses.

Device: Red-blue light exposure

Interventions

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

Red Ligh Group

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

Combined Red-Blue Light Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Putian University

Putian, China

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Chenxing C Jian

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

September 4, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

August 14, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations