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Third Degree BurnsNCT02285517

Comparing Modified Meek and Mesh Techniques

A study testing modified Meek skin grafting technique and mesh skin grafting technique in people with Third Degree Burns, run by Shahraki, Babak N., M.D..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a clinical trial study that compare two plastic surgery techniques in patients with third degree of burning and both techniques are used in all patients but in different areas of burning sites of the patients. Read more about this study

Who is it for?
Any age
Conditions the study is for
Third Degree Burns
What is being tested?
modified Meek skin grafting technique and mesh skin grafting technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Apr 2013to Jul 2014
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • third degree of burning

Who cannot join

  • infected lesions

About this study

Official title: Comparing Mesh and Modified Meek Skin Grafting Techniques in Third Degree Burned Patients Referred to Burn Ward of Khatam-al-anbia Hospital, Irtan

This is a clinical trial study that compare two plastic surgery techniques in patients with third degree of burning and both techniques are used in all patients but in different areas of burning sites of the patients.

Read the detailed description

PATIENT REGISTRATION:

The patients are registered after careful examination for third degree of burning and based on the need for skin grafting and of course a written consent were acquired. Excluded patients were those with an infected lesion or those who did not allow us to enter them into the study.

Progression of the treatment results of both techniques were visited by the surgeon regularly.

At the end of the study the data were checked with other similar studies. The acquired data were compared to other external data sources via medical records.

There were two standard operating techniques: modified meek skin grafting technique and mesh skin grafting technique.

The data was analyzed by chi-square and t-test.

Being tested
modified Meek skin grafting technique, mesh skin grafting technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modified Meek skin grafting techniqueProcedure or surgery

    patients with third degree of burns and without infected wounds are entered to the study and modified Meek skin grating technique is used to treat them and then the results of the procedure are compared to mesh skin grafting technique results by measuring the square centimeters of healed areas related to the technique

  • mesh skin grafting techniqueProcedure or surgery

    patients with third degree of burns and without infected wounds are entered to the study and mesh skin grating technique is used to treat them and then the results of the procedure are compared to modified Meek skin grafting technique results by measuring the square centimeters of healed areas related to the technique

Study groups in NCT02285517
Study groupRoleWhat they receive
modified Meek techniqueActive comparatorIntervention: modified Meek skin grafting technique. Patients with third degree of burns without infected wounds are included and the modified Meek results are studied , measured and compared to other group which is operated lesions by mesh technique
Receives: Procedure: modified Meek skin grafting technique
mesh techniqueActive comparatorIntervention: mesh skin grafting technique. patients with third degree of burns without infected wounds are included and the mesh skin grafting technique results are studied , measured and compared to other group which is operated lesions by modified Meek skin grafting technique
Receives: Procedure: mesh skin grafting technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measuring the size and speed of healing areas under treatment with two different skin graft techniques in a fourteen month period

    Comparing recovering areas operated by two different techniques: square centimeter was the scaling measure

    Measured: up to Fourteen months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2014
  4. Study completionJul 2014

Resources

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
Crossover
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285517
Sponsor's protocol ID
ShahrakiB
Status last verified
Nov 2014
First submitted
5 Oct 2014
Last updated
10 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 6. Hubley P. Review: evidence on dressings for superficial burns is of poor quality. Evid Based Nurs. 2009; 12(3): 78. 7. Jackson D. The diagnosis of the depth of burning. Br J Surg. 1953; 40(164): 558-96. 8. Kreise RW, Mackie DP, Hermans RP and Vlomans AR. Expansion techniques for skin grafts: comparison between mesh and Meek island (sandwich-) grafts. Burns. 1994; 20(1): s39-s42. 9. Jackson D, Topley E, Carson JS. Primary excision and grafting of large burns. Ann Surg. 1960; :152-167. 10. Macmillan BG. Early excision of more than 25% of budy surface in the extensively burned patients. Arch Surg. 1958; 77: 369. 11. Torpy JM, Lynm C, Glass RM. JAMA patient page. Burn injuries. JAMA. 2009; 302(16): 1828. 12. Meek CP. Successfull microdermagrafting using the Meek-wall microdermatome. Am J Surg. 1958; 96(4): 557-558.

  • 13. Lumenta DB, Kamolz LP, Frey M. Adult burn patients with more than 60% TBSA involved-Meek and other techniques to overcome restricted skin harvest availability--the Viennese Concept. J Burn Care Res. 2009; 30(2): 231-42. 14. Raff T, Hartmann B, Wagner H, Germann G. Experience with the modified Meek technique. Acta Chir Plast. 1996; 38(4): 142-146. 15. Kopp J, Magnus Noah E, Rubben A, et al. Radical resection of giant ongenital melanocytic nevus and reconstruction with meek-graft covered integra dermal template. Dermatol Surg. 2003; 29: 653-657. 16. Hsieh CS, Schuong JY, Huang WS, Huang TT. Five years' experience of the modified Meek technique in the management of extensive burns. Burns. 2008; 34(3): 350-354. 17. Wang Zy, He CP, Luo XL, Wang FS. [Clinical application of Meek skin grafting technique] Chinese [Abstract]. Nan Fang Yi Ke Da Xue Xue Bao. 2006; 26(5): 678-9,682.

  • 18. Holmes JH, Honari S. Excision and grafting of the large burn wound. Prob Gen surg. 2003; 20: 47. 19. Menon S, Li Z, Harvey JG and Holland AJ. The use of the Meek technique in conjunction with cultured epithelial autograft in the management of major paediatric burns. Burns. 2013; 39(4): 674-9. 20. Lin C, Chen GX, Zhang P, Lu CJ, Xu JJ, Luo X, Liu ZJ. [Comparison of cost between two ways of skin grafting in the treatment of patients with extensive deep burn] Chinese [Abstract]. Zhonghua Shao Shang Za Zhi. 2009; 25(4): 286-8. 21. Kreis RW, Mackie DP, Hermans RP and Vloemans AR. Expansion techniques for skin grafts: comparison between mesh and Meek island (sandwich-) grafts. Burns. 1994; 20(1): 39-42. 22. Lari AR, Gang RK. Expansion technique for skin grafts (Meek technique) in the treatment of severely burned patients. Burns. 2001; 27(1): 61-66.

  • 1. Endorf FW, Gibran NS. Burns. In: Brunicardi FC, Andersen DK, Billar TR, editors. Schwartz's principles of surgery. 9th ed. New York (USA): McGraw Hill; 2010: 197-206. 2. McGwin G, George RL, Cross JM, et al. Improving the ability to predict mortality among burn patients. Burns. 2008; 34: 320. 3. Ramos CG. Management of fluid and electrolyte disturbances in the burn patient. Annals of Burns and Fire Disasters 2000; 8(4): 21. 4. Wray CJ, Mayes T, Khoury J, Warden GD, Gottschlich M. The 2002 Moyer Award. Metabolic effects of vitamin D on serum calcium, magnesium, and phosphorus in pediatric burn patients.J Burn Care Rehabil. 2002; 23(6): 416-23. 5. Potokar T, Chamania S, Ali S. International network for training, education and research in burns. Indian J Plast Surg 2007;40:107

Questions about this trial

What is this clinical trial studying?

A study testing modified Meek skin grafting technique and mesh skin grafting technique in people with Third Degree Burns, run by Shahraki, Babak N., M.D..

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measuring the size and speed of healing areas under treatment with two different skin graft techniques in a fourteen month period (time frame: up to Fourteen months). 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 NCT02285517, which also lists 4 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 10 Nov 2014.

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