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OpenTrials
Completed

NCT Number: NCT03050203

Custom Pack in Spine Surgery

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 .

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Key information

Conditions

Bone Diseases Arthritis Central Nervous System Diseases Central Nervous System Neoplasms Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Osteoarthritis Osteoarthritis, Spine Rheumatic Diseases Spinal Cord Diseases Spinal Cord Neoplasms Spinal Diseases Spine Cancer Spine Osteoarthritis Spondylarthritis Spondylitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Degenerative spinal disease from 2 to 4 levels,
  • Oncologic spine disease with only decompression and stabilization.

Exclusion criteria

  • Revision surgeries,
  • Minimally invasive interventions,
  • Interventions that provide a dual access, and
  • Patients who refuse consent to experimentation.

Treatment and study plan

custom pack

Other

Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.

Standard care

Other

The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery

Primary outcomes

  1. Soft Tissue Dissecting Time

    Time frame: up to the first day post intervention

    minutes from the start of the dissection to complete bone cleaning

Secondary outcomes

  1. Surgery Time

    Time frame: up to the first day post intervention

    from the incision to the patient's sutures (minutes)

  2. Postoperative Complications

    Time frame: up to 2 weeks

    number of early wound infection

  3. Numbers of Materials Wasted

    Time frame: up to the first day post intervention

    amount of open sterile materials not used

  4. 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.

  5. 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.

  6. Length of Stay

    Time frame: up to 2 weeks

    number of days spent in hospital

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Acronym: kit

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2017
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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