Clinical trial NCT03709069: Effect of Enteral Albumin on Healing of Superficial Partial Thickness Fresh Flame Burns of Adults
Official title: Effect of Enteral Albumin on Healing of Superficial Partial Thickness Fresh Flame Burns of Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Partial-thickness Burn
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives routine diet while other group receives supplemental albumin along with routine diet
Primary purpose: TREATMENT

Brief summary: Patients with 10 to 20% Superficial partial thickness fresh flame burn will be recruited. Burn thickness will be confirmed by using Laser Doppler. After randomly allocating into two groups, one group will receive enteral supplemental albumin in the form of boiled egg along with routine diet while other group will receive only routine diet.

Effect of burn healing will be noted in terms of epithelization, oedema, pain and redness and days of hospital stay

Detailed description: Burn is an insult to the living tissues typically skin leading to coagulative necrosis due to extreme of temperature, electricity or chemicals. Burn injuries are a global public health problem with physical, psychological, social and economic implications on patients, their families and society as a whole. According to WHO, about 265,000 people die each year due to burn injuries. Vast majority of burn cases occur in middle and low socioeconomic groups of society. Any age group can be the victim of burn but people belonging to actively working class i.e. young adults (18-40yr) are more susceptible to burn injury. The most common sites of burn occurrence are domestic kitchen and workplaces from upset of receptacles containing hot liquids or directly from flames, electricity or cook stove burst.

Skin has outer covering of epidermis and deeper one is dermis. Burns, from management point of view, can be classified into superficial, superficial partial thickness, deep partial thickness and full thickness depending upon the extent of layers of skin involved. Superficial burns do not need specialized treatment and heal by their own while deep partial thickness and full thickness burns mostly require surgical procedures for management. Patients having superficial partial thickness burn wounds are the group of particular interest in burn centers due to two reasons. Firstly, the majority of burn injuries fall in this group and secondly, these are the wounds which, if managed well, heal in three weeks satisfactorily without any surgical intervention. The superficial partial thickness burn wounds involve damage to epidermis as well as partial dermis and characterized by Slough (yellowish white fibrinous tissue containing proteinacious material, pus and fibrin on wound surface), Erythema (redness of burn skin surface), Ooze (excessive fluid loss).

According to American Burn Association recommendations, patients having superficial partial thickness burn more than 10% body surface area need hospitalization for management. Multiple factors play role in the healing of superficial partial thickness burn wounds like age, co-morbidities (diabetes, HTN, obesity etc), immunosuppressive medications (steroids, chemotherapy) and nutritional status. Management of superficial partial thickness burn wound requires pain management, dressings, topical ointments and culture guided antibiotics. Despite of all these maneuvers, good nutritional support in the form of both micronutrients and macronutrients particularly proteins are critical component of acute burn wound care. Early optimal nutrition administration in management of burn patients particularly involves proteins rich diet due to lot of oozing from large wound surface area, high catabolism of muscles and vast tissue repair.

Protein enrichment of diet, for burn patients, can be achieved by adding albumin, which is easily available from many sources especially egg and plays vital role in burn wound healing. Albumin, synthesized by liver, is one the major proteins which has several important functions. Albumin, composed of essential amino acids, is primary serum binding protein required for transportation of various substances in blood circulation. Albumin administration is much easier through enteral route. Deficit of albumin occurs due to decreased synthesis during inflammatory conditions and, in burns, is further augmented by a shift in distribution of albumin to interstitial space from vascular compartment. A deficiency of albumin level can impair burn wound healing process whereas increased albumin level does not cause significant clinical complication. Hypo-albuminemia caused by wound exudation is the major predictor after injury that results in shock induction secondary to major extracellular fluid loss by increasing vascular permeability.

The rationale of this study is to find out effects of albumin supplementation on hospital stay by affecting healing of superficial partial thickness burn wounds by.

Eligibility criteria: Inclusion Criteria:

* 10-20% superficial partial thickness flame burn determined by LASER Doppler.
* Age between 18-40years.
* Fresh burn wound
* Patient with BMI ranging from 18.9-24.9.

Exclusion Criteria:

* Patient not willing to participate
* Any co-morbidities (i.e. DM, HTN, CRF, CCF, CLD)
* Patient with abnormal baseline serum albumin levels
* Patients not taking diet from hospital kitchen
* Patient known allergic to albumin
* Patient put on nil per oral (NPO)

Primary outcomes:
measure: Wound epithelization
timeFrame: 3 weeks
Secondary outcomes:
measure: Effect on pain: PRS
timeFrame: 3 weeks
measure: Change in Oedema
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Burn Center
state: Punjab
Study officials:
affiliation: KEMU Lahore
name: Afzaal Bashir, FCPS,MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treharne LJ, Kay AR. The initial management of acute burns. J R Army Med Corps. 2001 Jun;147(2):198-205. doi: 10.1136/jramc-147-02-15.