Clinical Trial: Custom Pack in Spine Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Surgical Field Custom Pack's Efficacy on Soft Tissue Dissecting Time Reduction, on Relative Risks and Materials Wasted, in Patients Undergoing Spine Surgery: Randomized Controlled Trial

Brief Summary: Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .

Detailed Summary:
Sponsor: Istituto Ortopedico Rizzoli

Current Primary Outcome: Soft tissue dissecting time [ Time Frame: up to the first day post intervention ]

minutes from the start of the dissection to complete bone cleaning


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • surgery time [ Time Frame: up to the first day post intervention ]
    from the incision to the patient's sutures (minutes)
  • postoperative complications [ Time Frame: up to 2 weeks ]
    number of early wound infection
  • numbers of materials wasted [ Time Frame: up to the first day post intervention ]
    amount of open sterile materials not used
  • blood loss [ Time Frame: up to 2 weeks ]
    Levels of hemoglobin and hematocrit intraoperative (gas analysis before and after surgery) compared to hemoglobin and hematocrit before surgery and number of blood transfusions both intra- and postoperative.
  • pain (Score on the "Numeric Rating Scale") [ Time Frame: up to the first 3 days post intervention ]
    Pain Score on the "Numeric Rating Scale". The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain.
  • Length of stay [ Time Frame: up to 2 weeks ]
    number of days spent in hospital


Original Secondary Outcome: Same as current

Information By: Istituto Ortopedico Rizzoli

Dates:
Date Received: February 1, 2017
Date Started: September 2, 2015
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017