NCT03148977

Brief Summary

The objective of this study is to determine whether our chemical assay can be used to reliably predict graft take or failure in patients undergoing autologous skin grafting for treatment of acute burn injury.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

3.5 years

First QC Date

May 9, 2017

Last Update Submit

March 23, 2021

Conditions

Keywords

Matrix Metalloproteinases

Outcome Measures

Primary Outcomes (1)

  • Predictability of graft take

    Determine whether chemical assay can be used to reliably predict graft take or failure in patients undergoing autologous skin grafting for treatment of acute burn injury.

    2 years

Secondary Outcomes (1)

  • Wound healing

    2 years

Study Arms (1)

Patients admitted to the burn center

Patients admitted to the Burn Service with acute burn injuries requiring at least one surgical excision and grafting operation.

Procedure: Graft

Interventions

GraftPROCEDURE

Autogenous skin grafting is the only definitive treatment for the full thickness burn injuries, and thus represents the centerpiece of modern burn care.

Patients admitted to the burn center

Eligibility Criteria

Age18 Years - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult burn patients admitted

You may qualify if:

  • years of age or older
  • Burn injury less than one week old

You may not qualify if:

  • Electrical, chemical or cold-induced burn injury
  • Total body surface area burn \>50 %
  • Patients not expected to survive
  • Patients presenting with re-injury to previously burned and treated areas.
  • Patients who present after receiving burn excision surgery out an outside facility for the current acute injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health Cancer Hospital

Gainesville, Florida, 32608, United States

Location

UF Health Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Weigelt MA, Lev-Tov HA, Tomic-Canic M, Lee WD, Williams R, Strasfeld D, Kirsner RS, Herman IM. Advanced Wound Diagnostics: Toward Transforming Wound Care into Precision Medicine. Adv Wound Care (New Rochelle). 2022 Jun;11(6):330-359. doi: 10.1089/wound.2020.1319. Epub 2021 Jul 21.

Biospecimen

Retention: SAMPLES WITH DNA

Acute burn wound exudate Acute burn wound tissue

MeSH Terms

Conditions

Burns

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Joshua S. Carson, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 11, 2017

Study Start

June 9, 2017

Primary Completion

December 8, 2020

Study Completion

December 8, 2020

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations