Partial-thickness BurnNCT03709069
Effect of Enteral Albumin on Healing of Superficial Partial Thickness Fresh Flame Burns of Adults
A study testing Albumin supplementation in people with Partial-thickness Burn, run by King Edward Medical University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Partial-thickness Burn
- What is being tested?
- Albumin supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2018to 9 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Burn Center
Lahore, Punjab Province, 54000
Afzaal Bashir, FCPS, MPhil, +923064000110, dr.afzaal@yahoo.com
About this study
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
Read the 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.
- Conditions
- Partial-thickness Burn
- Being tested
- Albumin supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin supplementationDietary supplement
Enteral supplementation by albumin of boiled egg as 2mg per kg body weight.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Albumin supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (2)
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.
Measured: 3 weeks
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start10 Nov 2018 (estimated)
- Primary completion9 Apr 2019 (estimated)
- Study completion9 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial-thickness BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives routine diet while other group receives supplemental albumin along with routine diet
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afzaal Bashir, FCPS,MPhil, Principal investigator, KEMU Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709069
- Sponsor's protocol ID
- Alb-burn
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11464415
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Albumin on Healing of Superficial Partial Thickness Fresh Flame Burns of Adults
- ClinicalTrials.gov ID
- NCT03709069
- Acronym / sponsor ID
- Alb-burn
- Conditions
- Partial-thickness Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2018 (estimated)
- Primary completion
- 9 Apr 2019 (estimated)
- Study completion
- 9 Apr 2019 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- One group receives routine diet while other group receives supplemental albumin along with routine diet
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Albumin supplementationInterventional 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin supplementationEnteral supplementation by albumin of boiled egg as 2mg per kg body weight. | Dietary supplement | Albumin Group |
Primary outcome
Wound epithelization
Time frame: 3 weeks
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.
2 secondary outcomes
Effect on pain: PRS
Time frame: 3 weeks
Change in Oedema
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 11464415Treharne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afzaal Bashir, FCPS,MPhil principal investigator
KEMU Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin supplementation in people with Partial-thickness Burn, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afzaal Bashir (+923064000110, dr.afzaal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound epithelization (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.