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Enrolling by Invitation

NCT Number: NCT07300137

Comparison of Amniotic Membrane Dressing and Aquacel®Ag in Second-degree Burns

To compare the outcome of amniotic membrane dressing versus Aquacel® Ag dressing with respect to the duration of healing in patients with second-degree burns within the local demographic setting. This study aims to address the existing gap in the literature by comparing the efficacy of amniotic membrane dressing and Aquacel® Ag dressing in the management of second-degree burns. Although Aquacel® Ag has been extensively studied for partial-thickness burns, it has not been directly compared with human amniotic membrane dressing, and no randomized controlled trial has yet evaluated these two treatment modalities. The findings of this study are expected to provide healthcare providers with an effective and cost-efficient dressing option for burn patients, particularly in resource-limited countries, while minimizing morbidity.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patel hospital

Karachi, Sindh, 75300, Pakistan

About this study

Burns pose a significant global health burden, particularly in low- and middle-income countries. Optimal wound care is essential to enhance healing, reduce complications, and minimize the need for surgical interventions. Human amniotic membrane dressings and silver-impregnated hydrofiber dressings such as Aquacel® Ag are commonly used options for the management of second-degree burns, each offering distinct biological properties and clinical benefits.

This randomized controlled trial aims to compare the efficacy of amniotic membrane dressing with Aquacel® Ag (sodium carboxymethylcellulose silver dressing) in terms of wound healing in patients with second-degree burns. The study will include patients presenting within 72 hours of injury with burns involving ≤40% total body surface area (TBSA). A total of 100 participants will be enrolled using non-probability convenience sampling and randomized through a computer-generated method into two groups. Group A will receive amniotic membrane dressings, while Group B will be treated with Aquacel® Ag dressings.

In Group A, dressings will be changed every 72 hours. In Group B, secondary dressings will be changed and the wound will be reviewed for soakage or gross contamination, with dressings continued until complete wound healing is achieved. Based on the study hypothesis, amniotic membrane dressings are expected to provide a clinically superior alternative to Aquacel® Ag dressings in the management of second-degree burns, particularly with respect to healing time and participant comfort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • second degree burns (till 40% TBSA)
  • In patients/ OPD
  • Fire Burn, Scald Burn, Flash Burn.

Exclusion criteria

  • Referred Cases, Infected Wounds, Diabetic Patients/ on immunosuppressants/ corticosteroids,
  • Electrical & Chemical Burns/

Treatment and study plan

preserved amniotic membrane dressing

Biological

application of preserved human amniotic membrane as a biological dressing for second degree burn wounds

Primary outcomes

  1. Healing

    Time frame: 21days

    comparison of healing time between aqua cel and amniotic membrane dressing

Sponsors and collaborators

Lead sponsor

Patel Hospital, Pakistan

Other

Registry information

Official study title

Comparison of Outcome of Amniotic Membrane Dressing vs Sodium Carboxylic Methyl Cellulose Silver Dressing (Aquacel®Ag) in Terms of Healing in Second-Degree Burns - A Randomized Controlled Trial''

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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