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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amniotic membrane dressing group | Experimental | application of preserved amniotic membrane dressing on second degree burns until healed |
|
| Aqua cel (Ag) dressing group | Active Comparator | application of aqua cel dressing on second degree burns until healed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preserved amniotic membrane dressing | Biological | application of preserved human amniotic membrane as a biological dressing for second degree burn wounds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing | comparison of healing time between aqua cel and amniotic membrane dressing | 21days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shazra Khalid, MBBS | Patel Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patel hospital | Karachi | Sindh | 75300 | Pakistan |
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| Label | URL |
|---|---|
| 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. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| comparison of 2 dressings | comparison between two types of dressings | View IPD |
IPD as per performa / questionnaire will be shared
When study will be published
anyone who asks for it
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analyst only
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Mean duration of healing with sodium Carboxylic methyl-cellulose silver dressing was less than petroleum gauze dressing for management of second-degree burns. |