Wound Additives in Primary Total Joint Athroplasty | NCT03158623

Studies
Wound Additives in Primary Total Joint Athroplasty

NCT03158623

Sponsor

Salt Lake Orthopedic Clinic

Status

Completed

Last Update Posted

May 18, 2017Actual

Enrollment

90Actual

Phase

Phase 3

Conditions

Arthroplasty, Replacement

Interventions

Platelet Rich Plasma
Cellerate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Dec 6, 2016Actual

Completion Date

Dec 20, 2016Actual

First Submitted Date

May 15, 2017

First Submission Date that Met QC Criteria

May 17, 2017

First Posted Date

May 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2017

Last Update Posted Date

May 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

3 cohorts of total joint patient of 30 members each were randomized to receive PRP or Activated Collegen or no additive were studied for status of the wound at 6 weeks and recorded all complications, infections and reoperations. The three groups were than compared for statistical analysis

Detailed Description

Background: Wound healing remains a concern in primary total joint arthroplasty given the risk of deep infections arising from hematomas, wound separations, and superficial infections. If wound additives can prevent these early complications, their universal application would be cost effective. This study examined whether two wound additives, Platelet-Rich Plasma (PRP) and CellerateRX® (activated collagen), would improve postoperative wound healing and reduce complications in primary total joint arthroplasty.

Methods: A prospective, randomized, controlled study using three cohorts with 30 patients each (Group 1: PRP, Group 2: activated collagen, Group 3: control) were examined postoperatively at two and six weeks, at which time the following data were recorded: six wound measurements, total postoperative blood loss, complications of superficial infections, and reoperations.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Platelet Rich Plasma	Experimental	30cc of PRP was administered at closure of wound	Biological: Platelet Rich Plasma
Cellerate (Activated Collegen)	Experimental	1gm of Cellerate was administered at closure of wound	Biological: Cellerate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet Rich Plasma	Biological		Platelet Rich Plasma	PRP
Cellerate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound Status	wound hematoma, dehiscence, superficial infection	6 weeks post operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Osteoathritis of knee and hip

Exclusion Criteria:

Inflammatory arthritis and hypercoagulable state

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan on sharing data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided