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

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''

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Second Degree Burns
• Intervention / Treatment: Biological: preserved amniotic membrane dressing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75300
      • Patel hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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/

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amniotic membrane dressing group; application of preserved amniotic membrane dressing on second degree burns until healed	Biological: preserved amniotic membrane dressing; application of preserved human amniotic membrane as a biological dressing for second degree burn wounds
Active Comparator: Aqua cel (Ag) dressing group; application of aqua cel dressing on second degree burns until healed	Biological: preserved amniotic membrane dressing; application of preserved human amniotic membrane as a biological dressing for second degree burn wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing	comparison of healing time between aqua cel and amniotic membrane dressing	21days

Collaborators and Investigators

• Sponsor: Patel Hospital, Pakistan
• Investigators: Principal Investigator: Shazra Khalid, MBBS, Patel hospital

Publications and helpful links

Helpful Links

• Published article providing background information on the comparison of sodium carboxylic methyl-cellulose silver dressing versus standard petroleum gauze dressing for management of second-degree burns.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: second degree burns.; amniotic membrane.; Aqua cel.; wound healing.
• Other Study ID Numbers: RFC_024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD as per performa / questionnaire will be shared
• IPD Sharing Time Frame: When study will be published
• IPD Sharing Access Criteria: anyone who asks for it
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Study Data/Documents

1. comparison between two types of dressings
   Information identifier: comparison of 2 dressings
   Information comments: Mean duration of healing with sodium Carboxylic methyl-cellulose silver dressing was less than petroleum gauze dressing for management of second-degree burns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No