Trial Outcomes & Findings for Prospective Randomized Trial of Stratafix vs. Vicryl in Total Hip Arthroplasty. (NCT NCT03285555)

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

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	STRATAFIX GROUP For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue 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 For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 Participants For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue VICRYL: Vicryl #1	Total n=60 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 13 • n=30 Participants	66 years STANDARD_DEVIATION 10 • n=30 Participants	63 years STANDARD_DEVIATION 12 • n=60 Participants
Sex: Female, Male Female	13 Participants n=30 Participants	19 Participants n=30 Participants	32 Participants n=60 Participants
Sex: Female, Male Male	17 Participants n=30 Participants	11 Participants n=30 Participants	28 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Wound length, cm	12 centimeters STANDARD_DEVIATION 1.8 • n=30 Participants	13 centimeters STANDARD_DEVIATION 1.4 • n=30 Participants	12 centimeters STANDARD_DEVIATION 1.6 • n=60 Participants

PRIMARY outcome

Timeframe: Day of surgery

Population: total hip arthroplasty patients

Time from first needle insertion to complete skin closure per protocol

Outcome measures

Outcome measures
Measure	STRATAFIX GROUP n=30 Participants For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 Participants For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue VICRYL: Vicryl #1
Time to Close, Minutes	18.0 minutes Standard Deviation 0.35	21.0 minutes Standard Deviation 0.43

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 For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 Participants For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue VICRYL: Vicryl #1
Number of Participants With Wound Complications	1 Participants	1 Participants

Adverse Events

STRATAFIX GROUP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

CONTROL GROUP

Serious events: 0 serious events

Other events: 1 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 For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture	CONTROL GROUP n=30 participants at risk For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat 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, Ethicon; Johnson \& Johnson) followed by the use of steri-strips and glue VICRYL: Vicryl #1
Infections and infestations Stitch abscess	3.3% 1/30 • 90 days postoperative	0.00% 0/30 • 90 days postoperative
Musculoskeletal and connective tissue disorders Trochanter bursitis	0.00% 0/30 • 90 days postoperative	3.3% 1/30 • 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