Custom Pack in Spine Surgery

Istituto Ortopedico Rizzoli37 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bone Diseases Spine Cancer Spine Osteoarthritis

Interventions

custom packOTHER

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 careOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

Outcomes

Primary Outcomes

Soft Tissue Dissecting Time

minutes from the start of the dissection to complete bone cleaning

Time frame: up to the first day post intervention

Secondary Outcomes

Surgery Time

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

Time frame: up to the first day post intervention

Postoperative Complications

number of early wound infection

Time frame: up to 2 weeks

Numbers of Materials Wasted

amount of open sterile materials not used

Time frame: up to the first day post intervention

Blood Loss

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.

Time frame: up to 2 weeks

Pain (Score on the "Numeric Rating Scale")

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.

Time frame: up to the first 3 days post intervention

Length of Stay

number of days spent in hospital

Time frame: up to 2 weeks

Data from ClinicalTrials.gov

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