Wound Additives in Primary Total Joint Athroplasty

The Effects of Platelet-Rich Plasma and Activated Collagen on Wound Healing in Primary Total Joint Arthroplasty

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement
• Intervention / Treatment: Biological: Platelet Rich Plasma; Biological: Cellerate

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Osteoathritis of knee and hip

Exclusion Criteria:

• Inflammatory arthritis and hypercoagulable state

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Rich Plasma; 30cc of PRP was administered at closure of wound	Biological: Platelet Rich Plasma; Other Names: PRP
Experimental: Cellerate (Activated Collegen); 1gm of Cellerate was administered at closure of wound	Biological: Cellerate; Other Names: Activated college

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Salt Lake Orthopedic Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 6, 2016
• Study Completion (Actual): December 20, 2016

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: total joint arthroplasty; platelet-rich plasma; activated collagen
• Other Study ID Numbers: IRB #891013-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan on sharing data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No