A study to evaluate the efficacy of amniotic membrane as a wound dressing in patients with large wound following trauma.
Phase 3
Completed
- Conditions
- Health Condition 1: T07- Unspecified multiple injuries
- Registration Number
- CTRI/2019/08/020572
- Lead Sponsor
- INSTITUTE RESEARCH GRANT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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 %
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.Incidence of (hypo- or hyper-) pigmentation, contracture and scar formation <br/ ><br>2.Any incidence of wound complications ( e.g. discharge , inflammation , infection ) <br/ ><br>3.Pain assessment with Visual Analog Scale. <br/ ><br>4.Any adverse events <br/ ><br>Timepoint: Time Frame: Baseline , 7th , 14th , 28th day of treatment period