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Effect of Enteral Albumin on Healing of Superficial Partial Thickness Fresh Flame Burns of Adults

Primary Purpose

Partial-thickness Burn

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Albumin supplementation
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial-thickness Burn

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Burn CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Traditional Group

Albumin Group

Arm Description

Traditional group receives diet from hospital kitchen quantity of which calculated depending on calorie requirement per kg body weight. This diet is same for all burn patients fulfilling the inclusion criteria of the study and it will be labelled as routine diet. Wounds of patients will be managed by closed dressing to be changed on every third day.

Interventional group receiving enteral supplemental albumin 2mg per kg body weight along with routine hospital kitchen diet same as group A and same wound management with closed dressing to be changed on every third day similar to group A.

Outcomes

Primary Outcome Measures

Wound epithelization
Wound epithelization will be assessed by photographic image analysis. Serial photographs of wound will be taken on every third day and will be assessed by two independent blinded plastic surgeons to rate for epithelization. The process will be continued till complete epithelization is witnessed.

Secondary Outcome Measures

Effect on pain: PRS
Pain will be assessed using Numeral Rating Scale (PRS) by score of 10. Score of 0 will be taken as no pain and score of 10 as maximum pain felt ever by the patient. Pain scoring will be done on every third day till complete healing of wound is acheived.
Change in Oedema
Will be assessed clinically as well as by measuring the girth of the area on every third day and change will be recorded

Full Information

First Posted
October 5, 2018
Last Updated
October 23, 2018
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03709069
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2018 (Anticipated)
Primary Completion Date
April 9, 2019 (Anticipated)
Study Completion Date
April 9, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial-thickness Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group receives routine diet while other group receives supplemental albumin along with routine diet
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Group
Arm Type
No Intervention
Arm Description
Traditional group receives diet from hospital kitchen quantity of which calculated depending on calorie requirement per kg body weight. This diet is same for all burn patients fulfilling the inclusion criteria of the study and it will be labelled as routine diet. Wounds of patients will be managed by closed dressing to be changed on every third day.
Arm Title
Albumin Group
Arm Type
Experimental
Arm Description
Interventional group receiving enteral supplemental albumin 2mg per kg body weight along with routine hospital kitchen diet same as group A and same wound management with closed dressing to be changed on every third day similar to group A.
Intervention Type
Dietary Supplement
Intervention Name(s)
Albumin supplementation
Intervention Description
Enteral supplementation by albumin of boiled egg as 2mg per kg body weight.
Primary Outcome Measure Information:
Title
Wound epithelization
Description
Wound epithelization will be assessed by photographic image analysis. Serial photographs of wound will be taken on every third day and will be assessed by two independent blinded plastic surgeons to rate for epithelization. The process will be continued till complete epithelization is witnessed.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Effect on pain: PRS
Description
Pain will be assessed using Numeral Rating Scale (PRS) by score of 10. Score of 0 will be taken as no pain and score of 10 as maximum pain felt ever by the patient. Pain scoring will be done on every third day till complete healing of wound is acheived.
Time Frame
3 weeks
Title
Change in Oedema
Description
Will be assessed clinically as well as by measuring the girth of the area on every third day and change will be recorded
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afzaal Bashir
Phone
+923064000110
Email
dr.afzaal@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afzaal Bashir, FCPS,MPhil
Organizational Affiliation
KEMU Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Burn Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afzaal Bashir, FCPS, MPhil
Phone
+923064000110
Email
dr.afzaal@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11464415
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.
Results Reference
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Effect of Enteral Albumin on Healing of Superficial Partial Thickness Fresh Flame Burns of Adults

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