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

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''

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07300137
Enrollment
100
Registered
2025-12-23
Start date
2025-09-20
Completion date
2026-08-01
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second Degree Burns

Keywords

second degree burns., amniotic membrane., Aqua cel., wound healing.

Brief summary

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.

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.

Interventions

BIOLOGICALpreserved amniotic membrane dressing

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

Sponsors

Patel Hospital, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

analyst only

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frameDescription
Healing21dayscomparison of healing time between aqua cel and amniotic membrane dressing

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORShazra Khalid, MBBS

Patel Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026