NCT03763383

Brief Summary

Abstract Introduction For local reconstruction on upper extremity or as a distant micro vascular flap Lateral arm free flap is an excellent source of tissue with the advantages including short operation time, thin pliable tissue, non-dominant vessel and minimal donor site morbidity, it fulfills the goal of an optimal reconstruction of form, function, and aesthetics .Here the investigator share his experience of lateral arm fasciocutaneous flap, investigator found it effective in covering defects secondary to trauma, malignancy and burns. Methods A retrospective data analysis was done to analyze our usage of lateral arm flap. This included patient's age, sex, primary problem, area involved, size of the flap and outcome of the flap 3 weeks post operatively. For free flaps this also included the recipient artery used for anastomosis and the number of veins anastomosed. Results There were 21 flaps done over a period of five years. This included 11 free flaps and 10 pedicle flaps. Average size of free flap was 12x5 cm and that of pedicle flap was 8x5 cm. In the free flap group, there was failure in 2 flaps both of which were due to arterial anastomoses in zone of injury. In the pedicle flap group however, there were no failures. Conclusion Lateral arm flap is a reliable flap with consistent anatomy that can be used for coverage in different parts of the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

5 years

First QC Date

November 16, 2018

Last Update Submit

December 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Flap survival/necrosis

    was assessed by clinical examination noticing color and bleeding by needle prick

    3 weeks

Study Arms (2)

Free lateral arm flap

included patients who had free lateral Arm flap

Procedure: Lateral Arm Flap

pedicled lateral arm flap

included patients who had pedicled lateral arm flap

Procedure: Lateral Arm Flap

Interventions

Its a kind of flap that is harvested from the lateral aspect of the arm to cover defects in different parts of the body

Free lateral arm flappedicled lateral arm flap

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • patients who underwent free Lateral Arm Flap
  • Patients who underwent pedicled Lateral arm flap -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74600, Pakistan

Location

Related Publications (13)

  • Song YG, Chen GZ, Song YL. The free thigh flap: a new free flap concept based on the septocutaneous artery. Br J Plast Surg. 1984 Apr;37(2):149-59. doi: 10.1016/0007-1226(84)90002-x.

    PMID: 6713155BACKGROUND
  • Wong CH, Wei FC. Anterolateral thigh flap. Head Neck. 2010 Apr;32(4):529-40. doi: 10.1002/hed.21204.

    PMID: 19672962BACKGROUND
  • Katsaros J, Schusterman M, Beppu M, Banis JC Jr, Acland RD. The lateral upper arm flap: anatomy and clinical applications. Ann Plast Surg. 1984 Jun;12(6):489-500. doi: 10.1097/00000637-198406000-00001.

    PMID: 6465806BACKGROUND
  • Katsaros J, Tan E, Zoltie N, Barton M, Venugopalsrinivasan, Venkataramakrishnan. Further experience with the lateral arm free flap. Plast Reconstr Surg. 1991 May;87(5):902-10. doi: 10.1097/00006534-199105000-00015.

    PMID: 2017499BACKGROUND
  • Scheker LR, Kleinert HE, Hanel DP. Lateral arm composite tissue transfer to ipsilateral hand defects. J Hand Surg Am. 1987 Sep;12(5 Pt 1):665-72. doi: 10.1016/s0363-5023(87)80045-x.

    PMID: 3309019BACKGROUND
  • Wenig BL. The lateral arm free flap for head and neck reconstruction. Otolaryngol Head Neck Surg. 1993 Jul;109(1):116-9. doi: 10.1177/019459989310900121.

    PMID: 8336957BACKGROUND
  • Agha RA, Fowler AJ, Rajmohan S, Barai I, Orgill DP; PROCESS Group. Preferred reporting of case series in surgery; the PROCESS guidelines. Int J Surg. 2016 Dec;36(Pt A):319-323. doi: 10.1016/j.ijsu.2016.10.025. Epub 2016 Oct 19.

    PMID: 27770639BACKGROUND
  • Sauerbier M, Germann G, Giessler GA, Sedigh Salakdeh M, Doll M. The free lateral arm flap-a reliable option for reconstruction of the forearm and hand. Hand (N Y). 2012 Jun;7(2):163-71. doi: 10.1007/s11552-012-9395-3.

    PMID: 23730235BACKGROUND
  • Kuek LB, Chuan TL. The extended lateral arm flap: a new modification. J Reconstr Microsurg. 1991 Jul;7(3):167-73. doi: 10.1055/s-2007-1006775.

    PMID: 1890673BACKGROUND
  • Harpf C, Papp C, Ninkovic M, Anderl H, Hussl H. The lateral arm flap: review of 72 cases and technical refinements. J Reconstr Microsurg. 1998 Jan;14(1):39-48. doi: 10.1055/s-2007-1006900.

    PMID: 9524002BACKGROUND
  • Klinkenberg M, Fischer S, Kremer T, Hernekamp F, Lehnhardt M, Daigeler A. Comparison of anterolateral thigh, lateral arm, and parascapular free flaps with regard to donor-site morbidity and aesthetic and functional outcomes. Plast Reconstr Surg. 2013 Feb;131(2):293-302. doi: 10.1097/PRS.0b013e31827786bc.

    PMID: 23357991BACKGROUND
  • Graham B, Adkins P, Scheker LR. Complications and morbidity of the donor and recipient sites in 123 lateral arm flaps. J Hand Surg Br. 1992 Apr;17(2):189-92. doi: 10.1016/0266-7681(92)90086-h.

    PMID: 1588201BACKGROUND
  • Depner C, Erba P, Rieger UM, Iten F, Schaefer DJ, Haug M. Donor-site morbidity of the sensate extended lateral arm flap. J Reconstr Microsurg. 2012 Feb;28(2):133-8. doi: 10.1055/s-0031-1289165. Epub 2011 Sep 29.

    PMID: 21959550BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sami Ullah (principal investigator)

Study Record Dates

First Submitted

November 16, 2018

First Posted

December 4, 2018

Study Start

January 1, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations