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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02285517
Other study ID # ShahrakiB
Secondary ID
Status Completed
Phase N/A
First received October 5, 2014
Last updated November 7, 2014
Start date April 2013
Est. completion date July 2014

Study information

Verified date November 2014
Source Shahraki, Babak N., M.D.
Contact n/a
Is FDA regulated No
Health authority Iran:Zahedan University of medical sciences
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- third degree of burning

Exclusion Criteria:

- infected lesions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
modified Meek skin grafting technique
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 technique
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shahraki, Babak N., M.D. Zahedan University of Medical Sciences

References & Publications (4)

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 a

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.

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to Fourteen months No
See also
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