NCT03285555

Prospective Randomized Trial of Stratafix vs. Vicryl in Total Hip Arthroplasty.

Completed NA Results posted Last updated 17 November 2020

What this trial tests

NA trial testing STRATIFIX in Wound; Hip in 60 participants. Completed in 31 August 2019.

Timeline

26 September 2017

Primary endpoint
30 June 2019

31 August 2019

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	26 September 2017
Primary completion	30 June 2019
Estimated completion	31 August 2019
Sites	1 location across United States

Drugs / interventions tested

• STRATIFIX
• VICRYL — full drug profile →

Conditions studied

• Wound; Hip — all drugs for Wound; Hip →

Sponsor

The Cleveland Clinic

Who can join

Adults 18 to 80, any sex, with Wound; Hip. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Close, Minutes Primary · Day of surgery

Time from first needle insertion to complete skin closure per protocol

Group	Value	95% CI
STRATAFIX GROUP	18.0	± 0.35
CONTROL GROUP	21.0	± 0.43

Number of Participants With Wound Complications Secondary · 90 days postoperative

Superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.

Group	Value	95% CI
STRATAFIX GROUP	1
CONTROL GROUP	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days postoperative. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

STRATAFIX GROUP

Serious: 0/30 (0%)

Deaths: 0/30

CONTROL GROUP

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (2 terms — click to expand)

Reaction	System	STRATAFIX GROUP	CONTROL GROUP
Stitch abscess	Infections and infestations	—	—
Trochanter bursitis	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03285555 adverse events section.

Sponsor's own description

The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control suture device is a barbed suture that uses anchor technology to securely engage with the soft tissues while also eliminating the need for knots. The anchors, or barbs, are pressed out of the device core or formed within the core in a geometric pattern and arranged in a tapered manner to allow the device to pass through tissue in the direction toward the needle during closure. These knotless tissue control devices are deployed using a continuous technique, which is anticipated to be faster and more cost-effective than interrupted suturing.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Barbed sutures reduce arthrotomy closure duration and suture utilisation compared to interrupted conventional sutures for primary total hip arthroplasty: a randomised controlled trial.
   Sundaram K, Piuzzi NS, Klika AK, Molloy RM, et al · · 2021 · cited 13× · PMID 32188284 · DOI 10.1177/1120700020911891