Custom Pack in Spine Surgery

Bone Diseases Clinical Trial

— kit  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050203
• Other study ID #: 0033168
• Status: Completed
• Phase: N/A
• Start date: September 2, 2015
• Est. completion date: July 30, 2016

Study information

• Verified date: February 2017
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 30, 2016
• Est. primary completion date: June 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Osteoarthritis
• Osteoarthritis, Spine
• Spine Cancer
• Spine Osteoarthritis
• Spondylarthritis

Intervention

Other:
• custom pack
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
The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft Tissue Dissecting Time	minutes from the start of the dissection to complete bone cleaning	up to the first day post intervention
Secondary	Surgery Time	from the incision to the patient's sutures (minutes)	up to the first day post intervention
Secondary	Postoperative Complications	number of early wound infection	up to 2 weeks
Secondary	Numbers of Materials Wasted	amount of open sterile materials not used	up to the first day post intervention
Secondary	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.	up to 2 weeks
Secondary	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.	up to the first 3 days post intervention
Secondary	Length of Stay	number of days spent in hospital	up to 2 weeks