Custom Pack in Spine Surgery

Not Applicable

Completed

• Conditions: Bone Diseases; Spine Cancer; Spine Osteoarthritis
• Interventions: Other: custom pack; Other: standard care

• Registration Number: NCT03050203
• Lead Sponsor: Istituto Ortopedico Rizzoli

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 Description

Not available

Study Timeline

• Study Start: 2015-09-02
• Primary Completion: 2016-06-16
• Study Completion: 2016-07-30
• Status Verified: 2017-02
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-10
• Results First Submitted: 2018-08-08
• Results First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Results First Posted: 2019-01-28
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
custom pack	custom pack	-
standard care	standard care	-

Primary Outcome Measures

Name	Time	Method
Soft Tissue Dissecting Time	up to the first day post intervention	minutes from the start of the dissection to complete bone cleaning

Secondary Outcome Measures

Name	Time	Method
Surgery Time	up to the first day post intervention	from the incision to the patient's sutures (minutes)
Numbers of Materials Wasted	up to the first day post intervention	amount of open sterile materials not used
Pain (Score on the "Numeric Rating Scale")	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.
Postoperative Complications	up to 2 weeks	number of early wound infection
Blood Loss	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.
Length of Stay	up to 2 weeks	number of days spent in hospital

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy