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

NCT05174910 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-07-25

No results posted yet for this study

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.

Conditions

  • Anastomotic Leak Rectum

Interventions

DEVICE

Obsidian ASG

Application of an autologous platelet-rich fibrin matrix

Sponsors & Collaborators

  • Raffeiner GmbH

    collaborator INDUSTRY

  • European Commission

    collaborator OTHER

  • AF Schimetta GMbH

    collaborator UNKNOWN

  • Rivolution GmbH

    collaborator UNKNOWN

  • Vivostat

    lead INDUSTRY

Principal Investigators

  • Andreas Shamiyeh, Prim.Doz.Dr. · Kepler Universitätsklinikum Gmbh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-23
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Austria
  • Germany
  • Italy
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05174910 on ClinicalTrials.gov