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Impact of Obsidian ® ASG on Anastomotic Healing

NCT04386148 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2023-10-05

No results posted yet for this study

Summary

The use of regenerative medicine in colorectal surgery constitutes an entirely new therapeutic principle. The aim of this new therapeutic approach is to reduce the anastomotic leak rate and minimise morbidity and mortality. The literature identifies the leak rate for colorectal operations as 3-39%.

Conditions

  • Anastomotic Leak Rectum

Interventions

PROCEDURE

Obsidian ASG®

As part of the elective laparoscopic colorectal surgery, an autologous fibrin matrix was used as part of anastomotic technique in conjunction with activated thrombocytes (Obsidian ASG®). During anastomosis, this matrix was applied after resection onto the colorectal tissue surfaces with the aim of triggering tissue regeneration and improved wound healing.

Sponsors & Collaborators

  • Kepler University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-03-31
Completion
2021-12-31

Countries

  • Austria

Study Locations

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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 NCT04386148 on ClinicalTrials.gov