Wound Additives in Primary Total Joint Athroplasty

Salt Lake Orthopedic Clinic

Status and phase: Completed; Phase 3

Conditions: Arthroplasty, Replacement

Treatments: Biological: Cellerate; Biological: Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03158623

IRB #891013-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Osteoathritis of knee and hip

Exclusion criteria

• Inflammatory arthritis and hypercoagulable state

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Platelet Rich Plasma

Experimental group

Description:

30cc of PRP was administered at closure of wound

Treatment:

Biological: Platelet Rich Plasma

Cellerate (Activated Collegen)

Experimental group

Description:

1gm of Cellerate was administered at closure of wound

Treatment:

Biological: Cellerate