Trial Outcomes & Findings for Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty (NCT NCT03016078)

NCT ID: NCT03016078

Last Updated: 2018-02-14

Results Overview

The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: * Blistering (Yes/No) by visit * Redness under dressing (Yes/No) by visit * Redness outside dressing (Yes/No) by visit * Maceration under dressing (Yes/No) by visit * Maceration outside dressing (Yes/No) by visit

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Daily visits, up to 7 days
• Results posted on: 2018-02-14

Participant Flow

Investigation period: Feb 2017 - March 2017. The study was conducted on 21 enrolled subjects at one site in the US. Subjects included were 18 years, and above, undergoing elective primary hip or knee arthroplasty.

Participant milestones

Measure	Mepilex Border Post-Op Ag Dressing A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Mepilex Border Post-Op Ag Dressing A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Mepilex Border Post-Op Ag Dressing n=21 Participants A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
Age, Continuous	68.4 years STANDARD_DEVIATION 5.8 • n=21 Participants
Sex: Female, Male Female	10 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=21 Participants
Region of Enrollment United States	21 Participants n=21 Participants
Blistering	0 Number of blisters n=21 Participants

PRIMARY outcome

Timeframe: Daily visits, up to 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:

• Blistering (Yes/No) by visit
• Redness under dressing (Yes/No) by visit
• Redness outside dressing (Yes/No) by visit
• Maceration under dressing (Yes/No) by visit
• Maceration outside dressing (Yes/No) by visit

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Number of Participants With Damage to the Incision and Surrounding Skin Blistering visit 3	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Blistering visit 5	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Blistering visit 6	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Redness Under Dressing visit 3	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Redness Under Dressing visit 5	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Redness Under Dressing visit 6	5 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Redness Outside Dressing visit 3	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Redness Outside Dressing visit 5	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Redness Outside Dressing visit 6	2 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Maceration Under Dressing visit 3	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Maceration Under Dressing visit 5	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Maceration Under Dressing visit 6	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Maceration Outside Dressing visit 3	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Maceration Outside Dressing visit 5	0 Participants
Number of Participants With Damage to the Incision and Surrounding Skin Maceration Outside Dressing visit 6	0 Participants

SECONDARY outcome

Timeframe: Daily visits, up to 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Nurse/ Investigator evaluate: Leakage (No/Yes)

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Number of Participants With Leakage of the Dressing Leakage visit 2	0 Participants
Number of Participants With Leakage of the Dressing Leakage visit 3	0 Participants
Number of Participants With Leakage of the Dressing Leakage visit 5	0 Participants
Number of Participants With Leakage of the Dressing Leakage visit 6	0 Participants

SECONDARY outcome

Timeframe: Daily visits, up to 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Number of Participants With Dressing Sticking to the Staples/Sutures Dressing sticks to the staples visit 3	0 Participants
Number of Participants With Dressing Sticking to the Staples/Sutures Dressing sticks to the staples visit 5	0 Participants
Number of Participants With Dressing Sticking to the Staples/Sutures Dressing sticks to the staples visit 6	0 Participants

SECONDARY outcome

Timeframe: Daily visits, up to 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits..

Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Number of Participants With Bleeding Caused by Dressing Removal Bleeding caused by the dressing removal visit 3	0 Participants
Number of Participants With Bleeding Caused by Dressing Removal Bleeding caused by the dressing removal visit 5	0 Participants
Number of Participants With Bleeding Caused by Dressing Removal Bleeding caused by the dressing removal visit 6	0 Participants

SECONDARY outcome

Timeframe: 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

The number of days the dressing can stay on are evaluated

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Participants' Dressing Wear Time (Days)	6.35 days Standard Deviation 1.57

SECONDARY outcome

Timeframe: Daily visits, up to 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

To evaluate the number of dressing changes per subject

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Number of Dressing Changes Per Subject	1.00 Number of dressing changes per subject Standard Deviation 0.00

SECONDARY outcome

Timeframe: Daily visits, up to 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Evaluation of the Dressing Capacity of Handling Blood Poor visit 6	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Good visit 3	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Good visit 5	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Good visit 6	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Poor visit 3	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Poor visit 5	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Very good visit 3	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Very good visit 5	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Very good visit 6	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Excellent visit 3	0 Participants
Evaluation of the Dressing Capacity of Handling Blood Excellent visit 5	3 Participants
Evaluation of the Dressing Capacity of Handling Blood Excellent visit 6	19 Participants
Evaluation of the Dressing Capacity of Handling Blood Not applicable visit 6	1 Participants

SECONDARY outcome

Timeframe: Daily visits, up to 7 days

Population: The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change).

Nurse/ Investigator evaluate with No/Yes

Outcome measures

Measure	The Study Group n=21 Participants Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)	3 Participants

Adverse Events

The Study 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

Measure	The Study Group n=21 participants at risk Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Skin and subcutaneous tissue disorders Redness at border of derssing	4.8% 1/21 • Number of events 1 • Average of one Week

Additional Information

Global Clinical Research Director

Mölnlycke Health Care

Phone: +46 31 722 30 00

Email: info@monlycke.com

Results disclosure agreements

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