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Case Series Assessing TissuGlu® Surgical Adhesive in Flap Surgery for Decubitus Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03482999
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Cohera Medical, Inc.

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.

Condition or disease Intervention/treatment
Decubitus Ulcer Device: TissuGlu Surgical Adhesive

Detailed Description:
A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Assessing a Lysine-Derived Urethane Adhesive (TissuGlu® Surgical Adhesive) in Flap Surgery for Decubitus Repair
Actual Study Start Date : March 28, 2011
Actual Primary Completion Date : August 27, 2015
Actual Study Completion Date : August 27, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. reduce the post-operative duration of stay [ Time Frame: 30 days ]

  2. reduce the surgical revision rate [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. percent of patients requiring a revision [ Time Frame: 30 days ]

  2. duration of wound drainage [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Inclusion Criteria:

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

Exclusion Criteria:

  • expected flap size less than 5 sqcm

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Responsible Party: Cohera Medical, Inc. Identifier: NCT03482999    
Other Study ID Numbers: CLN-100-0025
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Skin Diseases