Health Condition 1: X088- Exposure to other specified smoke,fire and flames Health Condition 2: X088- Exposure to other specified smoke,fire and flames Health Condition 3: O- Medical and Surgical
Conditions
Interventions
Intervention1: Platelet Rich Plasma as surface application on raw burn wounds before skin grafting in Burn patients: Patients found suitable to enrolment during screening at day 10 to 14 post burns wi
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 3 to 20 percentage total body surface area burns at deep second degree and or third degree thermal burns at 10 to 14 days post burns Granulating wound with post burn raw areas Suitable for STSG between 2 to 3 weeks from the burn event as close to day 14 as possible
Exclusion criteria
Exclusion criteria: Patients unfit for surgery Sepsis and septic shock Multiple organ dysfunction Patient unfit to receive skin graft ß haemolytic Streptococcus infection at the site of application Haemoglobin less than 10gm percentage Serum Albumin less than 2 and half gm per dL Uncontrolled diabetes HbA1c more than 8 percentage Patient follow up not possible based on investigator discretion At 14th post operative day if patient was discharged before day 14 At 3 months and 6 months and one year for evaluation of scar Other conditions like Coagulation disorder Pregnancy Patient on systemic steroid use more than 21 days Malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean graft take percentage on on 14th post operative day after surgery The grafted site will be assessed for percentage of graft take by measuring the surface area of graft and observing the colour and presence of seroma and slough and graft adherence and rejection The percentage of graft take will be calculated as area of graft take per total area of graft x 100 Skin graft take observed by dressing change and taking photographs on day 0 day 7 and day 14Timepoint: Mean graft take percentage on post operative day 14 plus or minus one day | — |
Secondary
| Measure | Time frame |
|---|---|
| Time taken for complete wound healing defined for the purpose of this study as skin re epithelialization without drainage or dressing requirements expected to indicate more than 95 percentage epithelialization Frequency of adverse events like Hematoma or Seroma or Graft loss etc documented by photography Need for re operation defined for the purpose of this study as patient having to undergo skin grafting again for complete wound healing Need for re operation is indicative of graft failure and will be recorded as an adverse event Frequency of adverse events both expected and unexpected will be recorded Scar index at 3 months and 6 months and 1 year using POSAS Score Cost effectiveness of the intervention compared to the comparator To estimate in a subset of participants the association between growth factor levels like PDGF BB & TGF beta1 of activated PRP and clinical response as measured by graft take and wound healingTimepoint: one year | — |
Countries
India
Contacts
Public ContactDr Susmita Behera
Department of Transfusion Medicine SCB Medical College Cuttack
Outcome results
None listed