New advancements in peritoneal reconstruction may soon transform postoperative outcomes. A clinical trial, termed the SurgiPerito Trial, is now recruiting patients to evaluate the efficacy and safety of a high-purity type-I collagen scaffold for patients undergoing peritonectomy closure after cytoreductive surgery. Led by Adichunchanagiri Institute of Medical Sciences and JSS Medical College Hospital, this trial could mark an important development for addressing complications associated with major surgeries, including ovarian cancer and peritoneal surface malignancies.
What does the trial evaluate?
The SurgiPerito Trial is focused on assessing the performance of a high-purity type-I collagen scaffold in reducing postoperative complications after cytoreductive surgery. These complications, including postoperative adhesions, bowel obstructions, and surgical site infections, pose critical challenges for patient recovery. By investigating the use of advanced materials, researchers aim to compare this novel approach to the standard peritonectomy closure procedure.
Type-I collagen scaffolds are designed to support tissue regeneration and may offer greater compatibility for enhancing peritoneal reconstruction. While this study builds upon existing data, the results will provide additional clinical evidence needed for broader applications in oncological surgeries such as ovarian cancer treatment.
Who is eligible for participation?
The study is recruiting patients diagnosed with conditions such as peritoneal surface malignancies, ovarian cancer, postoperative adhesions, and bowel obstructions. Eligible participants will undergo cytoreductive surgery. The trial includes a comparison between those receiving the high-purity collagen scaffold and those undergoing the standard peritonectomy closure method.
Patients interested in participating can contact the trial sites at Adichunchanagiri Institute of Medical Sciences and JSS Medical College Hospital for more details. Enrollment criteria and further information are accessible through the official trial listing.
What are the regulatory implications?
Collagen-based medical devices, especially scaffolds intended for use in peritoneal reconstruction, fall under significant regulatory scrutiny to ensure their safety and effectiveness. Given the focus on tissue regeneration and infection control, the trial outcomes may influence future regulatory submissions and potentially expedite the approval of these scaffolds for wider clinical use.
This trial, supported by reputable academic and medical institutions, combines scientific rigor with adherence to regulatory standards. Findings from the study will likely guide future guidelines and safety benchmarks for similar medical devices globally.
FAQ
- What is the primary purpose of this trial?
To evaluate the safety and efficacy of a high-purity collagen scaffold for peritoneal reconstruction. - Who is conducting the trial?
The trial is sponsored by Adichunchanagiri Institute of Medical Sciences and JSS Medical College Hospital. - Where can participants learn more?
Full details about the trial are available at ClinicalTrials.gov. - Which conditions does the trial target?
The trial focuses on peritoneal surface malignancies, ovarian cancer, postoperative adhesions, bowel obstructions, and surgical site infections.
Conclusion
The SurgiPerito Trial represents a significant step forward in post-surgical advancements, with the potential to improve outcomes for individuals undergoing complex oncological procedures. Clinical and regulatory stakeholders alike are urged to monitor the trial outcomes as they may set the stage for innovations in reconstructive surgery. Potential participants can learn more through the study listing or by contacting the sponsoring institutions.
Disclaimer
This article provides information intended for clinical, quality, and regulatory professionals. It does not constitute legal or medical advice.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07241091?term=medical+device