Kerecis Case Registry for SurgiBind : Soft Tissue Reinforcement

NCT05898711 | Active Not Recruiting FDA Device

• 1 other identifier: KS-0710
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Registry Objectives The overall objective of the registry is to collect quality and safety data to assess the long-term outcomes of Kerecis Omega3 SurgiBind in surgical procedures to reinforce soft tissue and prevent surgical complications. The ultimate goal of the registry is to enhance the quality of care, patient outcomes and establish a resource to facilitate the use of fish skin in preventing surgical wound dehiscence and surgical site infection.

Conditions

Surgery-Complications

Outcome Measures

Primary Outcomes (1)

• Number of surgical complication: dehiscence, infection

  quantify the number of patients who experience postoperative wound complications including dehiscence and infection. Patients undergoing surgical procedures and experience wound complications are captured. Wound dehiscence will be categorized as superficial or deep. Infection (if appears) will be identified and recorded. Wounds are considered infected if the wound margins are erythematous and have one or combined of the following: active purulence or necrosis of underlying soft tissues.

  12 months

Secondary Outcomes (3)

• Time to healing:

  12 months

• Time to physical therapy initiation

  12 months

• Duration of physical therapy

  12 months

Study Arms (1)

All patients

All patients who meet inclusion/exclusion criteria

Device: Fish skin graft

Interventions

Fish skin graft DEVICE

Kerecis Fish Skin Graft - SurgiBind

All patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 18 that are scheduled for surgery and part of their surgical plan is to be treated with Kerecis SurgiBind product for soft tissue reinforcement.

You may qualify if:

• Age 18 and older
• Undergoing surgical procedure requiring soft tissue reinforcement with Kerecis Omega3 SurgiBind
• For example:
• Plastic reconstructive surgery
• Orthopedic surgery
• Cardiothoracic surgery
• Vascular Surgery
• General Surgery

You may not qualify if:

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• Participants who request not to be in the registry
• Life expectancy of less than 1 year

Sponsors & Collaborators

• Kerecis Ltd.: lead

Study Sites (1)

Kerecis

Arlington, Virginia, 22201, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 12, 2023
• Study Start: January 27, 2022
• Primary Completion: June 27, 2025
• Study Completion: January 27, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-10

Locations

US (1)