Wound Additives in Primary Total Joint Athroplasty

Arthroplasty, Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158623
• Other study ID #: IRB #891013-1
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2017
• Last updated: May 17, 2017
• Start date: April 1, 2016
• Est. completion date: December 20, 2016

Study information

• Verified date: May 2017
• Source: Salt Lake Orthopedic Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 20, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Osteoathritis of knee and hip

Exclusion Criteria:

• Inflammatory arthritis and hypercoagulable state

Related Conditions & MeSH terms

• Arthroplasty, Replacement

Intervention

Biological:
• Platelet Rich Plasma

• Cellerate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Salt Lake Orthopedic Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Status	wound hematoma, dehiscence, superficial infection	6 weeks post operative