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

NCT03709069 | Unknown

• 1 other identifier: Alb-burn
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Partial-thickness Burn

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (2)

• Effect on pain: PRS

  3 weeks

• Change in Oedema

  3 weeks

Study Arms (2)

Traditional Group

NO INTERVENTION

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.

Albumin Group

EXPERIMENTAL

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.

Dietary Supplement: Albumin supplementation

Interventions

Albumin supplementation DIETARY_SUPPLEMENT

Enteral supplementation by albumin of boiled egg as 2mg per kg body weight.

Albumin Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• % 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Mayo Burn Center

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 11464415 BACKGROUND

Study Officials

• Afzaal Bashir, FCPS,MPhil

  KEMU Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Afzaal Bashir

CONTACT

+923064000110; dr.afzaal@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group receives routine diet while other group receives supplemental albumin along with routine diet

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 17, 2018
• Study Start: November 10, 2018
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)