Clinical Trial: Excision of Strip of Deep Fascia to Reduce Seroma Formation and Extrusion of Tissue Expanders
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Excision of Strip of Deep Fascia to Reduce Seroma Formation and Extrusion of Tissue Expanders
Brief Summary:
Tissue expansion has enjoyed a wide range of applications since the technique was popularized in the latter quarter of the last century. During the expansion process, subcutaneous fat liquefies, skin becomes thinner, muscles atrophy, blood inflow increases, and lymphatics get occluded. All these factors predispose to seroma formation and implant extrusion.
A similar problem occurred with lymphoedema patients, and one of the lines of treatment was creation of a connection to the deep lymphatics to facilitate absorption of accumulated fluid. The same principle is to be extrapolated to patients having tissue expanders inserted in the neck and limbs and its effect is to be noted on the incidence of seroma .
Detailed Summary:
The techniques of tissue expansion have been used for many years to expand normal skin adjacent to the site of a defect. Initially described by Neuman in 1953, it gained widespread popularity in the eighth decade of the last century after the work of Radovan, and has been progressively popular since.
The physiology of prolonged tissue expansion was not just a matter of stretching skin, but the actual formation of additional new skin which had all the attributes of the original tissue. Austad et al. postulated that tissue expansion caused a decrease in cell density in the basal layer of the skin and that cell density might regulate skin mitotic activity. A lower cell density resulted in a greater cell proliferation, resulting in growth of additional skin. Inflation of the tissue expander was found to cause a threefold elevation of epidermal mitotic activity within 24 hours, followed by a gradual return to normal baseline over 2 to 5 days. Conversely, deflation of the expander caused a transient decrease in epidermal mitotic activity. The increase in mitosis returned to normal 4 weeks after expansion.
The dermis and subcutaneous tissues were thinned as a result of tissue expansion leading to an overall decrease in tensile strength of the expanded skin (5-7) and this persisted 36 weeks after expansion. The subcutaneous layer of fat was intolerant to stretching causing significant thinning. With faster expansion, fat necrosis could be seen. Pressure necrosis on subcutaneous fat led to liquefaction and seroma formation. With progression of expansion compression of superficial lymphatics resulted in their occlusion and lymph accumulation. Furthermore, the muscle layer in pigs, which was similar to the platysmal layer in humans, tended to atrophy with maximal expansion. As expansion proceeded, there was an increase in the number
Sponsor: Cairo University
Current Primary Outcome: Reduction of seroma formation [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Cairo University
Dates:
Date Received: August 27, 2009
Date Started: May 2006
Date Completion:
Last Updated: August 27, 2009
Last Verified: August 2009
