Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: AmchoPlast dehydrated human amnion chorion membrane allograft: Dose and Frequency Weekly once one Allograft
Route of administration
Topical
Duration of Therapy 4 Weeks
Intervent
Sponsors
LifeCell International Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with age between 18 and 55 years. The wound size measures 5 cm2 to 10 cm2 with the likely depth of less than 4 mm. Eligible primary wound types shall be acute superficial/partial thickness, clean, non-contaminated wounds not more than 4 mm in depth, including, but not limited too Burns (thermal/ electrical/ irradiation) Non/minimally exudating wounds Traumatic injuries (abrasion/laceration, ulceration) Donor skin graft area in patient undergoing major surgery The subject is willing to complete all follow-up evaluations required by the study protocol. The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless medically necessary. The subject agrees to abstain from enrolment in any other interventional clinical trial for the duration of the study. The subject and/or guardian is able to read and understand instructions and give informed, voluntary, written consent. The subject is able and willing to follow the protocol requirements. Female of childbearing age with a negative result for a pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial.
Exclusion criteria
Exclusion criteria: The subject has a microbiologically proven pre-existing local or systemic bacterial infection. The subject is receiving a systemic antibiotic for more than 48 hours prior to grafting. Wound size is less than 5cm2 or greater than 10cm2 or wound depth is more than 4mm. Hepatic disease or altered liver function as defined by ALT or AST value >3 times the upper limit of normal and/or T.Bilirubin >1.5 mg/dL at screening. Renal disease or altered renal function as defined by serum creatinine > 2 mg/dL at screening, or end-stage renal disease. Hemoglobin Male 17.5 g/dL Female Known coagulopathy or platelet disorder, or INR > 1.6 , PTT >38 sec; platelet count Random blood sugar above 160 mg/dL and HbA1c above 6.0 % The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with wound healing including but not limited to: current malignancy, uncontrolled diabetes, autoimmune disease or other immunocompromised diseases, renal impairment or ESRD, liver disease, hematological disorders. Patients with a known history of poor compliance with medical treatment. Patients who have been previously randomized into this study, or are presently participating in another clinical trial. Patients on anticoagulant medication will as in any surgical procedure be monitored according to the protocols employed at the enrolling center. Patients diagnosed with autoimmune connective tissues diseases. Non-revascularizable surgical sites. Wound involving weight-bearing surfaces (e.g. heel or forefoot wounds), Any pathology that would limit the blood supply and compromise healing. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days. Patients who are pregnant or breastfeeding. Patients who are taking medications that are considered immune system modulators which could affect graft incorporation. Patients who have received negative pressure wound therapy or hyperbaric oxygen therapy in the last 7 days or treatment with other advanced wound care products within the past 30 days. Patients allergic to Vancomycin, Ofloxacin and Amphotericin B and PHMB.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of the study shall be time to complete wound closure, as assessed over a 4 -week period from treatment initiation. Timepoint: Week 2 and Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete healing of the study wound is defined as 100% re epithelialization without drainage. Wound scar assessment questionnaire in the treatment periodTimepoint: 2 WEEKS AND 4 WEEKS | — |
Countries
India
Contacts
Public ContactMs Pallavi Misra
LifeCell International Pvt Ltd
Outcome results
None listed