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ACTIVE NOT RECRUITING
NCT05174910
NA

Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery

Sponsor: Vivostat

View on ClinicalTrials.gov

Summary

Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of hospital stay and higher costs. This study is an investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian ASG®) for treatment of anastomosis during rectal surgery - a single-blind, randomized, multicenter pilot study with enrollment of 2x125 patients The main objective of the study is to investigate on an exploratory basis whether the use of Obsidian ASG® during rectal resection reduces the frequency of postoperative anastomotic insufficiency compared to standard anastomotic technique. The secondary objectives of the study are to investigate on an exploratory basis: * The frequency of anastomotic insufficiency (ISREC Criteria) severity * Staple line bleeding requiring surgical intervention * The duration of postoperative hospitalization are reduced when using Obsidian ASG ® compared with standard anastomotic treatment alone. are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.

Official title: Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery - a Single-blind, Randomized, Multicenter Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2021-12-23

Completion Date

2024-12-31

Last Updated

2024-07-25

Healthy Volunteers

No

Interventions

DEVICE

Obsidian ASG

Application of an autologous platelet-rich fibrin matrix

Locations (13)

Krankenhaus der Barmherzigen Brûder

Graz, Austria

Kepler Universitätsklinikum GmbH, Med campus III

Linz, Austria

Krankenhaus der Barmherzigen Brüder Wien

Vienna, Austria

Landesklinikum Wienerneustadt

Wiener Neustadt, Austria

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, Germany

Universität Augsburg

Augsburg, Germany

Diakonissenkrankenhaus Dresden

Dresden, Germany

Klinikum Fürth

Fürth, Germany

Klinikum Nürnberg Nord

Nuremberg, Germany

University Milano

Milan, Italy

University Hospital Belgrade

Belgrade, Serbia

Granada Hospital

Granada, Spain

Consorci Hospital General Universitari de Valencia

Valencia, Spain