NCT04584723

Brief Summary

This study reports the experience in free tissue transfer in the elderly population by a single surgeon in the private practice setting in Mexico city and the potential criticism that could arise from adverse events in lower-volume practice situations will be addressed. Investigator will answer the question about the age as the variable of interest in this series in which age was not a factor in deciding reconstructive methods, and examine complication rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

October 6, 2020

Last Update Submit

December 4, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Flap survival

    Evaluation of success of microsurgical free flap. Flap necrosis or not

    1 month

  • Complications

    Report the number and type of local and systemic complications in this microsurgical procedures.

    1 month

Interventions

We will report the flap survival and complications in this population group underwent to microsurgical procedures in a private practice setting

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients more than 65 years old, with indications for a free flap reconstruction.

You may qualify if:

  • Elderly population, defined as more than 65 years old
  • Patients underwent to free flap microsurgical procedures.
  • Complete files
  • Patient acceptance to participate

You may not qualify if:

  • Lost follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Angeles Pedregal

Mexico City, Mexico City, 01330, Mexico

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 14, 2020

Study Start

May 1, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations