NCT05032625

Brief Summary

There is significant mortality associated with necrotizing soft tissue infections, it is imperative to decrease mortality and complications associated with this disease is determined. To accomplish this goal, study team will create a prospectively maintained database of all NSTI patients admitted at department of surgery. Investigators will asses the predictors of poor outcome and follow these patients for 1 year in clinic and asses the functional quality of life by incorporating 36-Item Short Form Survey (SF-36) score.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

August 13, 2020

Last Update Submit

September 1, 2021

Conditions

Necrotizing Soft Tissue Infection

Keywords

Necrotizing Soft Tissue Infection; Quality of life

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality. (Short term )

    The short term objectives are to evaluate 30-day mortality.

    30 days

Secondary Outcomes (1)

  • The quality of life survey (Long Term)

    1year

Interventions

SurgeryPROCEDURE

Patients who undergo surgery for NSTI will be followed in hospital and for 1- year in the office. We will asses the quality of life and there functionality. This will help us in determining the predictors of poor outcome.

Also known as: Quality of life survey

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients between 18 - 99 years of age who will undergo surgery for NSTI will be included in the study.

You may qualify if:

  • all patients ≥ 18 years presenting with necrotizing soft tissue infections admitted to Westchester Medical Center, who will undergo surgical management

You may not qualify if:

  • Age \< 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westchester Medical center

Valhalla, New York, 10595, United States

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Rifat Latifi, MD

    Chairman Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Felicien Steichen Professor and Chairman of Surgery

Study Record Dates

First Submitted

August 13, 2020

First Posted

September 2, 2021

Study Start

July 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

US(1)