Evaluation of use of human donor skin grafts in treating burn wounds.

Not yet recruiting

Conditions: Burn of unspecified body region, unspecified degree,

Registration Number: CTRI/2021/01/030558

Lead Sponsor: Dr Annappa Kudva

Brief Summary: Informedconsent will be obtained from all participants before enrolling into the study.Data regarding time of sustainment of burns and cause of burns will be recorded.Information regarding pre-existing illness/comorbidities will be collected. Alcoholconsumption and Tobacco usage history will be collected. Area of the burns ismeasured using Modified Lund and Browder chart and Palmar method, and depth ofthe wound will be mapped pictorially. Area of the Partial thickness burn woundAllografted will be measured postoperatively. After allografting wound will be evaluated on POD 4, POD 10, POD 15 and POD 21or on the day of discharge (which one of the either is the earliest) to lookfor healing. Area of the wound taken upfor early Auto grafting, if the wound is considered non healing after Allografting,will be measured and on which postoperative day after allografting the decision made by the treating unit andthe POD on which the wound is Autografted will be noted. Data regarding labparameters such as Haemoglobin, Serum electrolytes, Serum Total Proteins, Serumalbumin and Blood culture, wound culture sensitivity reports will be collected duringthe course of study period. Body weight of the patient will be measured at thetime of admission and weekly after Allografting. Pain scoring will be done, fromage 10 yrs to 75 yrs, at the time of admission on POD 4, POD 10, POD 15 and POD21 or on the day of discharge (which one of the either is the earliest). Dataregarding blood product transfusions, Albumin infusion and electrolyteimbalance corrections (post Allografting) will be collected. Informationregarding the illness/Disease/comorbidities found on evaluation by the treatingunit during the course of study will be collected. Percentage area of theallografted wound healed will be measured at the time of discharge. Feedbackwill be collected on follow up regarding nature of scar after 1week, 1month,2months, 3 months, after discharge. Statistics willbe provided at the end of study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients with Partial thickness burns undergoing tangential excision (Debridement) and allografting of burn wounds after hemodynamic stability in the department of Plastic Surgery.

Exclusion Criteria

1)Patients on Medications negatively affecting wound healing such as Corticosteroids, Chemotherapeutic agents.
2)Age > 75years, <1 year 3)Chemical induced Burns, Radiation Burns, Cold Burns, Immunocompromised patients and patient with collagen disorders.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of human skin allograft in the wound healing of partial thickness burn wounds as a definitive dressing.	Upto POD 21
Wound is considered healing based on either of the following criteria	Upto POD 21
1.Peeling of allograft with evidence of epithelization of surface underneath.	Upto POD 21
2.Grafted area appears dry or the secretions from the grafted area are decreased when inspected on POD 4, POD 10, POD 15 and POD 21.	Upto POD 21

Secondary Outcome Measures

Name	Time	Method
Allograft rejection and scar	Upto 3 months after allograft application

Trial Locations

Locations (1): Kasturba Hospital, Manipal
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital, Manipal
🇮🇳Udupi, KARNATAKA, India
Dr Sreekumar NC
Principal investigator
9809353454
ncs.kumar@manipal.edu