Trial Outcomes & Findings for Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty (NCT NCT03285542)

NCT ID: NCT03285542

Last Updated: 2021-05-13

Results Overview

Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars. Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 90 days postoperative
• Results posted on: 2021-05-13

Participant Flow

Participant milestones

Measure	DERMABOND GROUP For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)	CONTROL GROUP For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples Staples: staples for skin closure
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

Measure	DERMABOND GROUP n=30 Participants For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)	CONTROL GROUP n=30 Participants For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples Staples: staples for skin closure	Total n=60 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 8 • n=30 Participants	62 years STANDARD_DEVIATION 7 • n=30 Participants	62 years STANDARD_DEVIATION 8 • n=60 Participants
Sex: Female, Male Female	22 Participants n=30 Participants	15 Participants n=30 Participants	37 Participants n=60 Participants
Sex: Female, Male Male	8 Participants n=30 Participants	15 Participants n=30 Participants	23 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 90 days postoperative

Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars.

Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).

Outcome measures

Measure	DERMABOND GROUP n=30 Participants For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)	CONTROL GROUP n=30 Participants For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples Staples: staples for skin closure
Modified Hollander Cosmesis Scale Total score 0	30 Participants	0 Participants
Modified Hollander Cosmesis Scale Total score 1	0 Participants	23 Participants
Modified Hollander Cosmesis Scale Total score 2	0 Participants	5 Participants
Modified Hollander Cosmesis Scale Total score 3	0 Participants	1 Participants
Modified Hollander Cosmesis Scale Total score 4	0 Participants	1 Participants
Modified Hollander Cosmesis Scale Total score 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 90 days postoperative

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

Outcome measures

Measure	DERMABOND GROUP n=30 Participants For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)	CONTROL GROUP n=30 Participants For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples Staples: staples for skin closure
Number of Patients With Wound Complications	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 90 days postoperative

patient satisfaction with wound appearance, measured by marking on a line of 100 mm, with 0 mm being low and 100 mm being high.

Outcome measures

Measure	DERMABOND GROUP n=30 Participants For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)	CONTROL GROUP n=29 Participants For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples Staples: staples for skin closure
Patient Satisfaction (Visual Analogue Scale)	97.6 millimeters Standard Deviation 3.2	82.6 millimeters Standard Deviation 12.8

Adverse Events

DERMABOND GROUP

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

CONTROL GROUP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	DERMABOND GROUP n=30 participants at risk For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure. DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)	CONTROL GROUP n=30 participants at risk For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples Staples: staples for skin closure
Skin and subcutaneous tissue disorders Wound dehiscence	3.3% 1/30 • Number of events 1 • 90 days postoperative	0.00% 0/30 • 90 days postoperative
Skin and subcutaneous tissue disorders Superficial surgical site infection	3.3% 1/30 • Number of events 1 • 90 days postoperative	0.00% 0/30 • 90 days postoperative

Other adverse events

Adverse event data not reported

Additional Information

Viktor Krebs

Cleveland Clinic

Phone: 216-445-3843

Email: krebsv@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place