Comparison of Amniotic Membrane Dressing and Aquacel®Ag for of Healing of Second-Degree Burns - A Randomized Controlled Trial.

NCT ID: NCT07300137

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2026-08-01

Brief Summary

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To compare the outcome of Amniotic membrane dressing versus Aqua cel Ag the dressing pertaining to the duration of healing in second degree burn patients within the local demography.

Our research will bridge the literature gap by comparing the efficacy of amniotic membrane and aqua cel dressing in management of second-degree burns. Aqua cel® Ag has been studied extensively for partial-thickness (second-degree) burns, but not directly against human amniotic membrane and as there's no RCT yet to compare these both treatment modalities.

The findings of this study will offer healthcare providers a dressing technique for burn patients that will minimize morbidity while also being cost effective in resource-limited countries

Detailed Description

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Burns pose a significant global health burden, particularly in low- and middle-income countries. Optimal wound care is crucial to enhance healing, reduce complications, and minimize the need for surgical interventions. Human amniotic membrane dressings and silver-impregnated hydro fibre dressings such as Aqua cel® Ag are two widely used options specifically in Second-degree burns, each with unique biological properties and clinical benefits.

This study will aim to compare the efficacy of amniotic membrane dressing with Aqua cel® Ag (sodium carboxymethylcellulose silver dressing) in terms of healing in patients with second-degree burns.A randomized controlled trial will be conducted on patients with second-degree burns presenting within 72 hours involving ≤40% total body surface area (TBSA). Total 100 participants will be selected for this study by non-probability convenience sampling, randomized by computer generated method and divided into two groups Group A will receive dressings with an amniotic membrane, while Group B will be treated with Aqua Cel dressings. Dressings will be changed every 72 hours in Group A and whereas in Group B secondary dressing will be changed and reviewed for any soakage or gross contamination and will be continued until complete wound healing is achieved.

as per our hypothesis; amniotic membrane dressings will offer a clinically superior alternative to Aqua cel® Ag dressing in the management of second-degree burns, particularly in terms of healing time and patient comfort.

Conditions

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Second Degree Burns

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

analyst only

Study Groups

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Amniotic membrane dressing group

application of preserved amniotic membrane dressing on second degree burns until healed

Group Type EXPERIMENTAL

preserved amniotic membrane dressing

Intervention Type BIOLOGICAL

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

Aqua cel (Ag) dressing group

application of aqua cel dressing on second degree burns until healed

Group Type ACTIVE_COMPARATOR

preserved amniotic membrane dressing

Intervention Type BIOLOGICAL

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

Interventions

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preserved amniotic membrane dressing

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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/
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patel Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Shazra Khalid

Resident Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Patel hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Study Documents

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Document Type: comparison between two types of dressings

View Document

Related Links

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https://pjmhsonline.com/index.php/pjmhs/article/view/3992

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.

Other Identifiers

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RFC_024

Identifier Type: -

Identifier Source: org_study_id