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

NCT07300137 | Enrolling By Invitation

• 1 other identifier: RFC_024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Second Degree Burns

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Healing

  comparison of healing time between aqua cel and amniotic membrane dressing

  21days

Study Arms (2)

Amniotic membrane dressing group

EXPERIMENTAL

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

Biological: preserved amniotic membrane dressing

Aqua cel (Ag) dressing group

ACTIVE COMPARATOR

application of aqua cel dressing on second degree burns until healed

Biological: preserved amniotic membrane dressing

Interventions

preserved amniotic membrane dressing BIOLOGICAL

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

Amniotic membrane dressing group; Aqua cel (Ag) dressing group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• second degree burns (till 40% TBSA)
• In patients/ OPD
• Fire Burn, Scald Burn, Flash Burn.

You may not qualify if:

• Referred Cases, Infected Wounds, Diabetic Patients/ on immunosuppressants/ corticosteroids,
• Electrical \& Chemical Burns/

Sponsors & Collaborators

• Patel Hospital, Pakistan: lead

Study Sites (1)

Patel hospital

Karachi, Sindh, 75300, Pakistan

Location

Related 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 Officials

• Shazra Khalid, MBBS

  Patel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: analyst only
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Plastic Surgery

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 23, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When study will be published
• Access Criteria: anyone who asks for it

Locations

PA (1)