Effect of Red and Blue Light Irradiation on Postoperative Wound Healing in Perianal Abscess: a Single-center Prospective Open-label Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Wound healing time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years;
- •Clinical diagnosis of perianal abscess；
- •Procedure: Radical resection with incision and drainage.
排除标准
- •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.
研究组 & 干预措施
control group
Routine care of patients after surgery for perianal abscesses.
Red Ligh Group
Postoperative care of patients with perianal abscesses using routine plus red light irradiation.
干预措施: Red light exposure (Device)
Combined Red-Blue Light Group
Use of routine plus red and blue light in postoperative care of patients with perianal abscesses.
干预措施: Red-blue light exposure (Device)
结局指标
主要结局
Wound healing time
时间窗: Measurements were taken over a time frame of 24 hours postoperatively to complete epithelialisation.
Defined as 100% re-epithelialization assessed by blinded evaluator.
次要结局
- 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)