Second Degree BurnsNCT07300137
Comparison of Amniotic Membrane Dressing and Aquacel®Ag in Second-degree Burns
A study testing preserved amniotic membrane dressing in people with Second Degree Burns, run by Patel Hospital, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Second Degree Burns
- What is being tested?
- preserved amniotic membrane dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Sep 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- second degree burns (till 40% TBSA)
- In patients/ OPD
- Fire Burn, Scald Burn, Flash Burn.
Who cannot join
- Referred Cases, Infected Wounds, Diabetic Patients/ on immunosuppressants/ corticosteroids,
- Electrical \& Chemical Burns/
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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''
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.
Read the 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.
- Conditions
- Second Degree Burns
- Being tested
- preserved amniotic membrane dressing
- Keywords
- second degree burns., amniotic membrane., Aqua cel., wound healing.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preserved amniotic membrane dressingBiological
application of preserved human amniotic membrane as a biological dressing for second degree burn wounds
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane dressing group | Experimental | application of preserved amniotic membrane dressing on second degree burns until healed Receives: Biological: preserved amniotic membrane dressing |
| Aqua cel (Ag) dressing group | Active comparator | application of aqua cel dressing on second degree burns until healed Receives: Biological: preserved amniotic membrane dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
comparison of healing time between aqua cel and amniotic membrane dressing
Measured: 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start20 Sep 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Degree BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patel Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazra Khalid, Patel Hospital, Pakistan
- Investigators
- Shazra Khalid, MBBS, Principal investigator, Patel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300137
- Sponsor's protocol ID
- RFC_024
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD as per performa / questionnaire will be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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''
- ClinicalTrials.gov ID
- NCT07300137
- Acronym / sponsor ID
- RFC_024
- Conditions
- Second Degree Burns
- Keywords
- second degree burns., amniotic membrane., Aqua cel., wound healing.
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Patel Hospital, PakistanUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane dressing group | Experimental | Biological: preserved amniotic membrane dressingapplication of preserved amniotic membrane dressing on second degree burns until healed |
| Aqua cel (Ag) dressing group | Active comparator | Biological: preserved amniotic membrane dressingapplication of aqua cel dressing on second degree burns until healed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- second degree burns (till 40% TBSA)
- In patients/ OPD
- Fire Burn, Scald Burn, Flash Burn.
Key exclusion criteria (2 listed)
- Referred Cases, Infected Wounds, Diabetic Patients/ on immunosuppressants/ corticosteroids,
- Electrical \& Chemical Burns/
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preserved amniotic membrane dressingapplication of preserved human amniotic membrane as a biological dressing for second degree burn wounds | Biological | Amniotic membrane dressing group, Aqua cel (Ag) dressing group |
Primary outcome
Healing
Time frame: 21days
comparison of healing time between aqua cel and amniotic membrane dressing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD as per performa / questionnaire will be shared
Related trials for Second Degree Burns
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Not yet recruitingObservational study
Phoenixin and Pain in Pediatric Burn Patients
Children, Acute Pain
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
Not yet recruiting
Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel
Burn, Burn Contracture of Skin
Not yet recruitingObservational study
Cell Suspension With Biologic Dressing for Burn Wounds
Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shazra Khalid, MBBS principal investigator
Patel Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preserved amniotic membrane dressing in people with Second Degree Burns, run by Patel Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 21days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.