NCT03482999

Brief Summary

To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

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

March 28, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

4.4 years

First QC Date

March 22, 2018

Last Update Submit

March 28, 2018

Conditions

Decubitus Ulcer

Outcome Measures

Primary Outcomes (2)

  • reduce the post-operative duration of stay

    duration

    30 days

  • reduce the surgical revision rate

    rate

    30 days

Secondary Outcomes (2)

  • percent of patients requiring a revision

    30 days

  • duration of wound drainage

    30 days

Study Arms (2)

Control

Standard Wound Closure with drains

TissuGlu Surgical Adhesive

TissuGlu was used for approximation and adhesion of the flaps in conjunction with drains

Device: TissuGlu Surgical Adhesive

Interventions

TissuGlu Surgical AdhesiveDEVICE
TissuGlu Surgical Adhesive

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population included patients undergoing flap surgery for decubitus repair between March 2011 and July 2015. In October 2013, the investigator converted to the use of TissuGlu® Surgical Adhesive in conjunction with surgical drains as their standard of care for flap surgery for decubitus repair. The analysis was performed retrospectively on two consecutive cohort groups.

You may qualify if:

  • undergoing a procedure for decubitus repair
  • be 22 years of age or older

You may not qualify if:

  • expected flap size less than 5 sqcm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

March 29, 2018

Study Start

March 28, 2011

Primary Completion

August 27, 2015

Study Completion

August 27, 2015

Last Updated

March 29, 2018

Record last verified: 2018-03