The Role of Amniotic Membrane in Promoting Rapid Recovery of Buccal Mucosal Defect After Harvesting Oral Mucosa for Urethral Reconstruction

Zagazig University58 enrolled

Overview

investigators use biological material to enhance recovery of oral cavity row area after harvesting a graft from it to use it in urethral reconstruction

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Buccal Mucosal Defect

Interventions

use of amniotic membrane as a biological dressing over buccal mucosal raw areaBIOLOGICAL

use of amniotic membrane as a biological dressing over buccal mucosal raw area versus classic non closure technique after using BMG in urethroplasty for urethral stricture

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Zagazig University

Zagazig, Egypt

Outcomes

Primary Outcomes

Postoperative donor-site epithelialization of the buccal donor site using Oral Mucosa Rating Scale (OMRS)

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

Time frame: from the first day post op to 12 weeks

• Postoperative donor-site epithelialization of the buccal donor site using Landry Healing Index (HI) Scores

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:

Time frame: post op week 1 and 4

Postoperative donor-site epithelialization of the buccal donor site using Early wound healing score

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)

Time frame: post op day 1

Secondary Outcomes

Postoperative pain assessed by Visual Analogue Scale (VAS)

assessed by Visual Analogue Scale (VAS): form (0) which means no pain to (10) which means severe pain

Time frame: from first day post operative to 12 weeks

Degree of oral aperture restriction (trismus),

assessed by inter-incisor distance measurement

Time frame: Postoperative day 1 through week 12

Oral health-related quality of life

Data from ClinicalTrials.gov

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