BurnsNCT04965883
Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.
A study testing Excision and Grafting and dressing then delayed grafting in people with Burns, run by Sohag University at 1 site in Egypt.
Trial summary
All the patients will be included in the study will be resuscitated on arrival in our department. Detailed history will be taken and burn evaluation will take place in respect to TBSA according to Lund and Browder chart and burn depth. Dreesing will be done with topical antimicrobial agent. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Burns
- What is being tested?
- Excision and Grafting and dressing then delayed grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2021to 15 Mar 2022
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who had deep second and third degree burns.
- patients with flame and scald burns.
Who cannot join
- Patients who had only first or superficial second degree burns.
- patients with high voltage contact electric burns and chemical burns.
Trial locations and contacts
1 site in 1 country.
Gamal Y El sayed, MD contact
Egypt1 site
Shenouda gamil fayiez
Sohag
Mohamed A El mawalla, MD, +20 114 166 9474
About this study
- All the patients will be included in the study will be resuscitated on arrival in our department.
- Detailed history will be taken and burn evaluation will take place in respect to TBSA according to Lund and Browder chart and burn depth.
- Dreesing will be done with topical antimicrobial agent.
- Fluid resuscitation with lactated Ringer's solution according to modified Parkland's formula.
- Injectable proton pump inhibitors, and analgesics will be started as initial drug therapy.
- Close follow up of the patients will be done then evaluation of the patients will be done in the fourth day and dividing the patients into two groups: the first group "early exicion and grafting " and the second group " dressing and delayed grafting ".
- The first group will include patients with early surgery from 4 to 10 days since burn.
- Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn.
- Then the data will be collected and analyzed for comparison between the two groups regarding : the timing of operation and its relation to the length of stay, functional outcome and cost of treatment
Read the detailed description
- The first group will include :
- Patients with good general condition and hemodynamically stable that fit for early surgery.
- Patients that accept the option of early surgery and can give consent for it .
- Patients with available donor site for early grafting.
- Patients with burn at certain sites may be of priority for early excision and grafting to avoid long term complication of delayed wound healing such as : on joint surface, hands, feet, and face.
- The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time.
- The first dressing will be in the fifth day post operative.
- In the other hand the second group will include:
- Patients with bad general condition or hemodynamicaly unstable at the early excision period (4-10 days post burn).
- Patients that refuse early surgery and give no consent for early surgery.
- Patients with no available donner site for early excision and grafting during the fourth day evaluation .
- Conditions
- Burns
- Being tested
- Excision and Grafting, dressing then delayed grafting
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision and GraftingProcedure or surgery
reconstruction of deep burn by grafting
dressing then delayed graftingProcedure or surgery
multiple dressing and delayed grafting
| Study group | Role | What they receive |
|---|---|---|
| Early Excision and Grafting | Experimental | * The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time.
* The first dressing will be in the fifth day post operative. Receives: Procedure: Excision and Grafting |
| Dressing and Delayed Grafting | Experimental | • Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn. Receives: Procedure: dressing then delayed grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the number of blood units needed in both groups ( the first group : early exicion and grafting , the second group : dressing and delayed grafting )
We will estimate how many blood units needed in both groups since admission upto discharge from hospital.
Measured: one year
compare the cost of treatment in both groups
regarding how much money will be used since burn upto recovery measured by filling questionnaire by the patients.
Measured: one year
Secondary outcomes (1)
Compare the length of hospital stay between of early excision and grafting(EEG) versus dressing and delayed grafting(DDG) of deep burn.
how many days each group will spend in our hospital .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shenoda Gamel Fayez, Sohag University
- Investigators
- Mohamed A Elmwalla, MD, Study chair, Sohag university ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965883
- Sponsor's protocol ID
- Soh-Med-21-06-08
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forjuoh SN. Burns in low- and middle-income countries: a review of available literature on descriptive epidemiology, risk factors, treatment, and prevention. Burns. 2006 Aug;32(5):529-37. doi: 10.1016/j.burns.2006.04.002. Epub 2006 Jun 14.
PubMed 16777340Khadjibayev AM, Fayazov AD, Djabriyev DA, Kamilov UR. Surgical treatment of deep burns. Ann Burns Fire Disasters. 2008 Sep 30;21(3):150-2.
PubMed 21991128Janzekovic Z. A new concept in the early excision and immediate grafting of burns. J Trauma. 1970 Dec;10(12):1103-8. No abstract available.
PubMed 4921723
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.
- ClinicalTrials.gov ID
- NCT04965883
- Acronym / sponsor ID
- Soh-Med-21-06-08
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 16 Jul 2021 (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.
- All the patients will be included in the study will be resuscitated on arrival in our department.
- Detailed history will be taken and burn evaluation will take place in respect to TBSA according to Lund and Browder chart and burn depth.
- Dreesing will be done with topical antimicrobial agent.
- Fluid resuscitation with lactated Ringer's solution according to modified Parkland's formula.
- Injectable proton pump inhibitors, and analgesics will be started as initial drug therapy.
- Close follow up of the patients will be done then evaluation of the patients will be done in the fourth day and dividing the patients into two groups: the first group "early exicion and grafting " and the second group " dressing and delayed grafting ".
- The first group will include patients with early surgery from 4 to 10 days since burn.
- Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn.
- Then the data will be collected and analyzed for comparison between the two groups regarding : the timing of operation and its relation to the length of stay, functional outcome and cost of treatment
Detailed description
- The first group will include :
- Patients with good general condition and hemodynamically stable that fit for early surgery.
- Patients that accept the option of early surgery and can give consent for it .
- Patients with available donor site for early grafting.
- Patients with burn at certain sites may be of priority for early excision and grafting to avoid long term complication of delayed wound healing such as : on joint surface, hands, feet, and face.
- The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time.
- The first dressing will be in the fifth day post operative.
- In the other hand the second group will include:
- Patients with bad general condition or hemodynamicaly unstable at the early excision period (4-10 days post burn).
- Patients that refuse early surgery and give no consent for early surgery.
- Patients with no available donner site for early excision and grafting during the fourth day evaluation .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Excision and Grafting | Experimental | Procedure: Excision and Grafting* The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time. * The first dressing will be in the fifth day post operative. |
| Dressing and Delayed Grafting | Experimental | Procedure: dressing then delayed grafting• Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who had deep second and third degree burns.
- patients with flame and scald burns.
Key exclusion criteria (2 listed)
- Patients who had only first or superficial second degree burns.
- patients with high voltage contact electric burns and chemical burns.
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 |
|---|---|---|
| Excision and Graftingreconstruction of deep burn by grafting | Procedure or surgery | Early Excision and Grafting |
| dressing then delayed graftingmultiple dressing and delayed grafting | Procedure or surgery | Dressing and Delayed Grafting |
Primary outcome
Compare the number of blood units needed in both groups ( the first group : early exicion and grafting , the second group : dressing and delayed grafting )
Time frame: one year
We will estimate how many blood units needed in both groups since admission upto discharge from hospital.
compare the cost of treatment in both groups
Time frame: one year
regarding how much money will be used since burn upto recovery measured by filling questionnaire by the patients.
1 secondary outcome
Compare the length of hospital stay between of early excision and grafting(EEG) versus dressing and delayed grafting(DDG) of deep burn.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 16777340Forjuoh SN. Burns in low- and middle-income countries: a review of available literature on descriptive epidemiology, risk factors, treatment, and prevention. Burns. 2006 Aug;32(5):529-37. doi: 10.1016/j.burns.2006.04.002. Epub 2006 Jun 14.
- Background: PubMed 21991128Khadjibayev AM, Fayazov AD, Djabriyev DA, Kamilov UR. Surgical treatment of deep burns. Ann Burns Fire Disasters. 2008 Sep 30;21(3):150-2.
- Background: PubMed 4921723Janzekovic Z. A new concept in the early excision and immediate grafting of burns. J Trauma. 1970 Dec;10(12):1103-8. No abstract available.
- 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.
Gamal Y El sayed, MD contact
Mohamed A Elmwalla, MD study chair
Sohag university ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision and Grafting and dressing then delayed grafting in people with Burns, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 2 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 16 Jul 2021. 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 Egypt. 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 shenouda G Faiez, resident (01285122834, shenoda011111@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the number of blood units needed in both groups ( the first group : early exicion and grafting , the second group : dressing and delayed grafting ) (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT04965883, which also lists 3 linked publications.
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 16 Jul 2021.