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

P

Patel Hospital, Pakistan

Status

Invitation-only

Conditions

Second Degree Burns

Treatments

Biological: preserved amniotic membrane dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT07300137
RFC_024

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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/

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Amniotic membrane dressing group
Experimental group
Description:
application of preserved amniotic membrane dressing on second degree burns until healed
Treatment:
Biological: preserved amniotic membrane dressing
Aqua cel (Ag) dressing group
Active Comparator group
Description:
application of aqua cel dressing on second degree burns until healed
Treatment:
Biological: preserved amniotic membrane dressing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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