Trial Outcomes & Findings for Custom Pack in Spine Surgery (NCT NCT03050203)

Results Overview

minutes from the start of the dissection to complete bone cleaning

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

up to the first day post intervention

Results posted on

2019-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	Custom Pack 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 standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
Overall Study STARTED	19	18
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Custom Pack n=19 Participants 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 n=18 Participants standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery	Total n=37 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 16.7 • n=19 Participants	54.8 years STANDARD_DEVIATION 12.4 • n=18 Participants	53 years STANDARD_DEVIATION 14.7 • n=37 Participants
Sex: Female, Male Female	11 Participants n=19 Participants	8 Participants n=18 Participants	19 Participants n=37 Participants
Sex: Female, Male Male	8 Participants n=19 Participants	10 Participants n=18 Participants	18 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
degenerative disease	5 Participants n=19 Participants	5 Participants n=18 Participants	10 Participants n=37 Participants

PRIMARY outcome

Timeframe: up to the first day post intervention

minutes from the start of the dissection to complete bone cleaning

Outcome measures

Outcome measures
Measure	Custom Pack n=19 Participants 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 n=18 Participants standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
Soft Tissue Dissecting Time	38.6 minues Standard Deviation 11.1	34 minues Standard Deviation 19.5

SECONDARY outcome

Timeframe: up to the first day post intervention

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 weeks

number of early wound infection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to the first day post intervention

amount of open sterile materials not used

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 weeks

number of days spent in hospital

Outcome measures

Outcome data not reported

Adverse Events

Custom Pack

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cristiana Forni

Istituto Ortopedico Rizzoli

Phone: 0039516366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place