Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dhaka Medical College | OTHER |
Not provided
Not provided
Not provided
Not provided
Road traffic accidents (RTAs) remain a major public health concern worldwide and in Bangladesh, contributing significantly to injury, disability, and premature death. In resource limited settings like Bangladesh, it is crucial to understand the factors that influence survival following an RTA in order to develop effective prevention strategies and improve patient outcomes. Therefore, this study aims to determine the 30 day survival rate and identify predictors of survival among adult RTA victims treated at a tertiary care hospital in Bangladesh. The observational study will be carried out at Emergency and casualty department of Dhaka Medical College Hospital (DMCH) between October 2025 and March 2026. A total of 204 adults (≥18 years) presenting to the hospital's Casualty Department with RTA related injuries will be included. Informed written consent will be obtained from each patient or their legal guardian prior to enrollment. Data will be collected through structured face to face interviews, review of hospital records, and follow up on the 30th day of accident. The follow-up will be conducted either in person or by telephone. Variables will include patient demographics, accident circumstances, admission characteristics, injury pattern and severity, pre-hospital care, clinical condition at admission, hospital management provided, and treatment outcome. All data will be analyzed using SPSS version 25.0. Kaplan-Meier analysis will estimate survival probabilities, while Cox proportional hazards regression will be used to identify independent predictors of mortality. The findings of this study are expected to generate context-specific, evidence-based insights for strengthening trauma care protocols, gap related to emergency handling of the RTA patients, enhancing pre-hospital emergency services, and informing policy decisions aimed at reducing preventable RTA-related mortality and morbidity in Bangladesh.
Study Rationale:
Acne scars, notably atrophic scars, pose significant cosmetic and psychological concerns. Standard treatments include fractional lasers and microneedling-based interventions; however, rigorous comparative data in real-world clinical settings remain scarce. Recent evidence suggests ablative fractional CO2 laser and PRP-enhanced microneedling offer notable benefits. This split-face design allows direct comparison of efficacy, safety, and patient satisfaction between the modalities among Bangladeshi patients.
Study Design:
Type: Phase 3, open-label, randomized, split-face, comparative clinical trial
Planned Sample Size: 116 participants
Setting: Department of Dermatology, Dhaka Medical College Hospital, Bangladesh
Duration: April 2025 to March 2026
Randomization: Side of face assigned to either intervention via coin toss
Blinding: Open-label; outcome assessment by independent dermatologist blinded to intervention side
Eligibility Criteria:
Inclusion:
Age >18 years
Both sexes
Grade 2-4 acne scarring (Goodman & Baron qualitative grading)
Equal baseline scar grades on both facial halves
Atrophic scars only (no active acne)
Exclusion:
History of keloidal tendency
Bleeding or platelet disorders
Major surgery in past 6 months
Active facial infection (e.g., herpes, folliculitis)
HIV, hepatitis B surface antigen (HBsAg), or chronic illness
Pregnancy
Interventions:
Ablative Fractional CO2 Laser:
Pre-treatment: 2.5% lidocaine + 2.5% prilocaine cream (45 minutes), antiseptic cleansing
Device: SmartXide DOT Fractionated CO2 Laser (15 W, 800 μm spacing, 600 µs dwell, stack 2)
Three sessions, one month apart
PRP with Microneedling:
Pre-treatment: 2.5% lidocaine + 2.5% prilocaine cream (2 hours), antiseptic cleansing
PRP Preparation: 8 mL blood with double spin centrifugation to yield 2 mL PRP, platelet count verified
Intradermal PRP injection (nappage technique), followed by dermapen microneedling (1.5 mm depth, 12-needle cartridge, 4-directional passes)
Three sessions, one month apart
Follow-up and Data Collection:
Baseline, day 30, day 60, final (day 90 post first session)
Outcome measures collected via clinical assessments, standardized photographs, patient questionnaires, and independent dermatologist review
Adverse events monitored throughout
Outcome Measures:
Primary:
Change in Goodman & Baron quantitative and qualitative acne scar grades at 90 days
Secondary:
Independent dermatologist evaluation (10-point VAS, categorized for analysis)
Patient satisfaction (5-point Likert scale)
Frequency and type of adverse events/side effects
Subgroup analyses by scar severity, skin type, and sex
Statistical Analysis:
All analyses by intention-to-treat
Continuous data: Paired t-tests (within-group), independent t-test or Mann-Whitney U (between modalities)
Qualitative grades: McNemar's test (within-group), chi-square (between modalities)
Categorical responses (dermatologist VAS, satisfaction, side effects): chi-square or Fisher exact
95% confidence intervals, significance level 0.05
Safety Monitoring:
Data and Safety Monitoring Board (DSMB) of independent experts
GCP compliance and interim reviews
Adverse event reporting follows national and institutional guidelines
Ethical Considerations:
Written informed consent (Bengali/English)
Withdrawal permitted at any time without detriment to care
Confidential data handling in accordance with local regulations
Institutional ethics committee approval obtained
Keywords:
Acne scars, fractional CO2 laser, platelet-rich plasma, microneedling, randomized trial, Bangladesh, split-face, dermatology, Goodman and Baron, patient satisfaction, safety
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablative fractional CO2 laser | Active Comparator | Participants will receive ablative fractional CO₂ laser therapy on one side of the face using the SmartXide DOT Fractionated CO₂ Laser system. Treatment parameters include 15 W power, 800 µm spacing, 600 µs dwell time, and stack level 2. A total of three sessions will be administered, each one month apart. |
|
| Platelet-Rich Plasma (PRP) With Microneedling | Experimental | Participants will receive intradermal injections of autologous PRP followed by microneedling on the opposite side of the face. PRP will be prepared using a double-spin centrifugation method from 8 mL of venous blood. Microneedling will be performed with a Dermapen (12-needle cartridge, 1.5 mm depth) until pinpoint bleeding is observed. A total of three sessions will be administered, each one month apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablative Fractional CO₂ Laser | Procedure | Participants will receive ablative fractional CO₂ laser therapy on one side of the face using the SmartXide DOT Fractionated CO₂ Laser system. Treatment parameters: 15 W power, 800 µm spacing, 600 µs dwell time, stack level 2. Sessions: 3, each one month apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Goodman and Baron Acne Scar Grading (Quantitative and Qualitative) | Improvement in acne scars will be assessed using the Goodman and Baron quantitative global acne scarring grading system and qualitative global acne scarring grading system. | Day 30 (prior to Session 2), Day 60 (prior to Session 3), and at the final follow-up visit on Day 150 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Jahid Hasan, MBBS, MPH | Contact | +8801767818973 | dr.jahid61@gmail.com | |
| Tamanna Tabassum, MBBS, MPH | Contact | +8801755383138 | dr.tabassum1991@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhala Medical College | Dhaka | Bangladesh |
At this time, there is no plan to share individual participant data (IPD) from this study. This decision is based on institutional policy, local regulatory considerations, and the need to protect participant confidentiality. De-identified data may be considered for sharing in the future upon appropriate request and with approval from the study's ethical review committee, but no prospective data sharing plan is in place at present.
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, split-face, open-label trial. Each participant will receive ablative fractional CO₂ laser therapy on one side of the face and platelet-rich plasma (PRP) with microneedling on the other side. The split-face design allows within-participant comparison of the two treatment modalities.
Not provided
Not provided
Not provided
Not provided
|
| Platelet-Rich Plasma (PRP) With Microneedling | Procedure | Participants will receive intradermal autologous PRP injections prepared by double-spin centrifugation from 8 mL of venous blood, followed by microneedling with a Dermapen (12-needle cartridge, 1.5 mm depth). Endpoint: pinpoint bleeding. Sessions: 3, each one month apart. |
|