Trial Outcomes & Findings for The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty (NCT NCT03285529)

Results Overview

Time from first needle insertion to complete skin closure per protocol

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Day of surgery

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	STRATAFIX GROUP STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty. VICRYL: Vicryl #1
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STRATAFIX GROUP n=30 Participants STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 Participants The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty. VICRYL: Vicryl #1	Total n=60 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 7 • n=30 Participants	66 years STANDARD_DEVIATION 7 • n=30 Participants	67 years STANDARD_DEVIATION 7 • n=60 Participants
Sex: Female, Male Female	16 Participants n=30 Participants	17 Participants n=30 Participants	33 Participants n=60 Participants
Sex: Female, Male Male	14 Participants n=30 Participants	13 Participants n=30 Participants	27 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Wound length	17.1 centimeters STANDARD_DEVIATION 2.0 • n=30 Participants	16.1 centimeters STANDARD_DEVIATION 1.3 • n=30 Participants	16.6 centimeters STANDARD_DEVIATION 1.9 • n=60 Participants

PRIMARY outcome

Timeframe: Day of surgery

Time from first needle insertion to complete skin closure per protocol

Outcome measures

Outcome measures
Measure	STRATAFIX GROUP n=30 Participants STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 Participants The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty. VICRYL: Vicryl #1
Time to Close, Minutes	19 minutes Standard Deviation 0.08	28 minutes Standard Deviation 0.13

SECONDARY outcome

Timeframe: 90 days postoperative

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

Outcome measures

Outcome measures
Measure	STRATAFIX GROUP n=30 Participants STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 Participants The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty. VICRYL: Vicryl #1
Number of Participants With Wound Complications	3 Participants	3 Participants

Adverse Events

STRATAFIX GROUP

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CONTROL GROUP

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	STRATAFIX GROUP n=30 participants at risk STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 participants at risk The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty. VICRYL: Vicryl #1
Infections and infestations Superficial surgical site infection	3.3% 1/30 • 90 days postoperative	0.00% 0/30 • 90 days postoperative
Infections and infestations Wound dehiscence	0.00% 0/30 • 90 days postoperative	3.3% 1/30 • 90 days postoperative
Musculoskeletal and connective tissue disorders Wound hematoma	3.3% 1/30 • 90 days postoperative	0.00% 0/30 • 90 days postoperative
Infections and infestations Stitch abscess	3.3% 1/30 • 90 days postoperative	0.00% 0/30 • 90 days postoperative
Infections and infestations Wound discharge	0.00% 0/30 • 90 days postoperative	6.7% 2/30 • 90 days postoperative

Additional Information

Viktor Krebs

Cleveland Clinic

Phone: 216-444-2600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place