None listed
Conditions
Brief summary
Donor site of split skin graft is always in research for ideal wound dressing. This study will compare between the Amnion and Alginate dressing and will see the results in terms of wound epitelization, pain, wound infection and number of dressing changes. The long term follow up will be required to see for any wound hypertrophy.
Interventions
Amnion will be obtained after informed consent from enrolled healthy expecting mothers undergoing C-section, with no co-morbidities or infections, testing negative for HBV, HCV and HIV. Meconium-contaminated placenta would be discarded. Amnion will be separated from placenta by washing with large volumes of normal saline. Membranes would then be transferred to another container containing 70% glycerol and refrigerated at 4 degree centigrade.
A single sheet of graft would be harvested with Zimme
Amnion will be obtained after informed consent from enrolled healthy expecting mothers undergoing C-section, with no co-morbidities or infections, testing negative for HBV, HCV and HIV. Meconium-contaminated placenta would be discarded. Amnion will be separated from placenta by washing with large volumes of normal saline. Membranes would then be transferred to another container containing 70% glycerol and refrigerated at 4 degree centigrade. A single sheet of graft would be harvested with Zimmer dermatome, graft width of 4 inches, with the thickness of 0.010 inches. After harvesting the graft, the donor site would be covered with adrenaline-soaked gauze for 2 minutes to secure hemostasis. For Group A, Amnion will be retrieved from the fridge, dipped in normal saline for 10 min to remove glycerol and applied to the cleaned and dried donor site by the primary investigator, ensuring no air bubbles between it and the bed. Secondary dressing with gauze and crepe bandage will be done. The amnion will remain there till wound healing is achieved by epithelization. Will be followed up to atleast 2 weeks and up to 1 month.
Sponsors
Roeya-E-Rasul
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Candidates of Split-thickness skin graft harvested with Zimmer dermatome with the thickness of 0.010 inches and width of 4 inches, single sheet (20-30 cm), harvested from right or left thigh
Exclusion criteria
1. Patients with allergy to Alginate or any of the other products used determined on history and examination 2. Immunocompromised patients- with systemic infection determined on clinical examination. 3. Patients with serious and uncontrolled co-morbidities: diabetes, hypertension, ischemic heart disease determined on history and clinical examination. 4. Pregnant and lactating females. 5. Burn patients.
Outcome results
None listed