The Role of Amniotic Membrane in Promoting Rapid Recovery of Buccal Mucosal Defect After Harvesting Oral Mucosa for Urethral Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Postoperative donor-site epithelialization of the buccal donor site using Oral Mucosa Rating Scale (OMRS)
研究概览
简要总结
investigators use biological material to enhance recovery of oral cavity row area after harvesting a graft from it to use it in urethral reconstruction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients were eligible for inclusion if they met the following criteria:
- •Adult patients (≥18 years)
- •Diagnosed with anterior urethral stricture requiring substitution urethroplasty
- •Planned use of buccal mucosal graft for urethral reconstruction
- •Ability to provide informed consent and comply with follow-up protocol
排除标准
- •Patients were excluded if they had:
- •Previous buccal mucosal graft harvest
- •Active oral infection or mucosal pathology
- •History of oral malignancy or radiotherapy
- •Uncontrolled systemic disease (e.g., poorly controlled diabetes mellitus)
- •Immunosuppression or chronic steroid use
- •Known allergy to biological graft materials
研究组 & 干预措施
Amniotic membrane coverage group
Application of amniotic membrane in buccal graft site after harvesting buccal mucosa graft for using it in uretheroplasty
干预措施: use of amniotic membrane as a biological dressing over buccal mucosal raw area (Biological)
Classic non closure technique
Classic non closure technique of buccal graft site
结局指标
主要结局
Postoperative donor-site epithelialization of the buccal donor site using Oral Mucosa Rating Scale (OMRS)
时间窗: from the first day post op to 12 weeks
Oral Mucosa Rating Scale (OMRS): visual assessment of oral mucosa erythema, ulceration granulation, suppuration, and edema. * Erythema (Redness): from (0) normal to (3) severe * Ulceration: from (0) normal to (3) severe * Granulation Tissue (Healing/Chronic Inflammation): from (0) normal to (3) severe * Suppuration (Pus/Infection): from (0) normal to (3) severe * Edema (Swelling): from (0) normal to (3) severe
• Postoperative donor-site epithelialization of the buccal donor site using Landry Healing Index (HI) Scores
时间窗: post op week 1 and 4
Landry Healing Index (HI) Scores (1-5). The HI scores wound healing on a 1-to-5 scale, where a higher score indicates better, more accelerated healing:
Postoperative donor-site epithelialization of the buccal donor site using Early wound healing score
时间窗: post op day 1
EHS Component Breakdown (Total: 10 points): the higher the score indicate better healing * Clinical Signs of Re-epithelialization (CSR - 6 points max) * Clinical Signs of Hemostasis (CSH - 2 points max) * Clinical Signs of Inflammation (CSI - 2 points max)
次要结局
- Postoperative pain assessed by Visual Analogue Scale (VAS)(from first day post operative to 12 weeks)
- Degree of oral aperture restriction (trismus),(Postoperative day 1 through week 12)
- Oral health-related quality of life(Postoperative weeks 6 and 12)
研究者
mohamed elsayed mousa mohamed owis
Dr.
Zagazig University