NCT02285517

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

October 5, 2014

Last Update Submit

November 7, 2014

Conditions

Outcome Measures

Primary Outcomes (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

    up to Fourteen months

Study Arms (2)

modified Meek technique

ACTIVE COMPARATOR

Intervention: 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

Procedure: modified Meek skin grafting technique

mesh technique

ACTIVE COMPARATOR

Intervention: 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

Procedure: mesh skin grafting technique

Interventions

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

modified Meek 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

mesh technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • third degree of burning

You may not qualify if:

  • infected lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    RESULT

Study Officials

  • MOSTAFA DAHMARDEHEI, M.D

    Zahedan University of Medical Sciences

    PRINCIPAL INVESTIGATOR
  • BABAK Na SHAHRAKI, M.D

    PRIVATE OFFICE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2014

First Posted

November 7, 2014

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11