deltatrials
Completed NA INTERVENTIONAL 2-arm NCT00274625

Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery

Sponsor: Cook Biotech Incorporated

Updated 7 times since 2017 Last updated: Nov 10, 2014 Started: Aug 31, 2005 Primary completion: Sep 30, 2012 Completion: Sep 30, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00274625, this NA trial focuses on Hernia and Obesity and remains completed. Sponsored by Cook Biotech Incorporated, it has been updated 7 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. Prior to undergoing open bariatric surgery, patients will be randomized to receive either Surgisis Gold Graft or suture closure alone. Subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. Patients may see their primary care physician for the one and two follow-up visits.

This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. Prior to undergoing open bariatric surgery, patients will be randomized to receive either Surgisis Gold Graft or suture closure alone. Subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. Patients may see their primary care physician for the one and two follow-up visits.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotCompleted~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  4. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  5. Aug 2017 — Jun 2018 [monthly]

    Completed NA

Show 2 earlier versions
  1. Feb 2017 — Aug 2017 [monthly]

    Completed NA

  2. Jan 2017 — Feb 2017 [monthly]

    Completed NA

    First recorded

Aug 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cook Biotech Incorporated
  • Cook Group Incorporated
  • MED Institute, Incorporated
Data source: Cook Group Incorporated

For direct contact, visit the study record on ClinicalTrials.gov .