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A study to evaluate the efficacy of amniotic membrane as a wound dressing in patients with large wound following trauma.

To study the efficacy of amniotic membrane as an alternative wound dressing in patients with large posttraumatic raw area at level 1 Trauma Centerâ??

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020572
Enrollment
60
Registered
2019-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T07- Unspecified multiple injuries

Interventions

Intervention1: In the Group II amniotic membrane (AM): Patients with large posttraumatic area, amniotic membrane (AM) dressing will be used and held in place with a secondary dressing. Only the second

Sponsors

INSTITUTE RESEARCH GRANT
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who require wound dressing for external superficial wounds following trauma having the wound dimension of 10x10cm or more, till the period requiring definitive coverage ie skin grafting or the flaps cover.

Exclusion criteria

Exclusion criteria: 1.Infected wounds 2.Deep wounds & internal wounds. 3.Open fractures 4.Known cases of Diabetes Mellitus. 5.A skin disorder that is chronic or currently active and involves the areas to be examined in this trial. 6.Patients who are immune-compromised. 7.Patients on steroids. 8.Pregnancy or lactation 9.Liver enzymes raised to twice the normal range 10.Serum creatinine > 1.4 mg %

Design outcomes

Primary

MeasureTime frame
1.Early wound bed preparation for skin grafting in large post traumatic raw area by Bates Jensen Wound Assessment Tool and photo documentationTimepoint: Time Frame: Baseline , 7th , 14th , 28th day of treatment period

Secondary

MeasureTime frame
1.Incidence of (hypo- or hyper-) pigmentation, contracture and scar formation 2.Any incidence of wound complications ( e.g. discharge , inflammation , infection ) 3.Pain assessment with Visual Analog Scale. 4.Any adverse events Timepoint: Time Frame: Baseline , 7th , 14th , 28th day of treatment period

Countries

India

Contacts

Public ContactDR ABHINAV KUMAR

AIIMS, ND

drabhinav1975@gmail.com9311157766

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026