NCT00968318

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

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

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
Last Updated

August 28, 2009

Status Verified

August 1, 2009

Enrollment Period

2.3 years

First QC Date

August 27, 2009

Last Update Submit

August 27, 2009

Conditions

Seroma

Keywords

Tissue expanderseromaextrusionlymphaticsdeep fasciaRate of seroma formation after excision of strip of deep fascia

Outcome Measures

Primary Outcomes (1)

  • Reduction of seroma formation

    6 months

Study Arms (1)

Rate of seroma formation

OTHER

Excision of strip of deep fascia was assessed regarding the rate of seroma formation with tissue expander insertion

Procedure: Excision of strip of deep fascia

Interventions

Excision of strip of deep fasciaPROCEDURE

operative technique to excise deep fascia.

Rate of seroma formation

Eligibility Criteria

Age12 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tissue expanders in neck and limbs.

You may not qualify if:

  • Tissue expanders in other parts of the body.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Adler N, Dorafshar AH, Bauer BS, Hoadley S, Tournell M. Tissue expander infections in pediatric patients: management and outcomes. Plast Reconstr Surg. 2009 Aug;124(2):484-489. doi: 10.1097/PRS.0b013e3181adcf20.

    PMID: 19644263BACKGROUND

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adel Wilson, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

May 1, 2006

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

August 28, 2009

Record last verified: 2009-08

Locations

EG(1)