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Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016078
Recruitment Status : Completed
First Posted : January 10, 2017
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Arthroplasties, Hip Replacement
Arthroplasties, Knee Replacement
Intervention Device: Mepilex Border Post-Op Ag
Enrollment 21
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Mepilex Border Post-Op Ag Dressing
Hide Arm/Group Description A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
Period Title: Overall Study
Started 21
Completed 19
Not Completed 2
Reason Not Completed
Protocol Violation             1
Protocol Violation             1
Arm/Group Title Mepilex Border Post-Op Ag Dressing
Hide Arm/Group Description A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
All variables measured at baseline were summarised for the ITT and PP populations using appropriate summary statistics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
68.4  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
10
  47.6%
Male
11
  52.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
 100.0%
Blistering  
Measure Type: Number
Unit of measure:  Number of blisters
Number Analyzed 21 participants
0
1.Primary Outcome
Title Number of Participants With Damage to the Incision and Surrounding Skin
Hide Description

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
Time Frame Daily visits, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Blistering visit 3 Number Analyzed 1 participants
0
   0.0%
Blistering visit 5 Number Analyzed 3 participants
0
   0.0%
Blistering visit 6 Number Analyzed 20 participants
0
   0.0%
Redness Under Dressing visit 3 Number Analyzed 1 participants
0
   0.0%
Redness Under Dressing visit 5 Number Analyzed 3 participants
0
   0.0%
Redness Under Dressing visit 6 Number Analyzed 20 participants
5
  25.0%
Redness Outside Dressing visit 3 Number Analyzed 1 participants
0
   0.0%
Redness Outside Dressing visit 5 Number Analyzed 3 participants
0
   0.0%
Redness Outside Dressing visit 6 Number Analyzed 20 participants
2
  10.0%
Maceration Under Dressing visit 3 Number Analyzed 1 participants
0
   0.0%
Maceration Under Dressing visit 5 Number Analyzed 3 participants
0
   0.0%
Maceration Under Dressing visit 6 Number Analyzed 20 participants
0
   0.0%
Maceration Outside Dressing visit 3 Number Analyzed 1 participants
0
   0.0%
Maceration Outside Dressing visit 5 Number Analyzed 3 participants
0
   0.0%
Maceration Outside Dressing visit 6 Number Analyzed 20 participants
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Leakage of the Dressing
Hide Description Nurse/ Investigator evaluate: Leakage (No/Yes)
Time Frame Daily visits, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Leakage visit 2 Number Analyzed 21 participants
0
   0.0%
Leakage visit 3 Number Analyzed 20 participants
0
   0.0%
Leakage visit 5 Number Analyzed 20 participants
0
   0.0%
Leakage visit 6 Number Analyzed 20 participants
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Dressing Sticking to the Staples/Sutures
Hide Description Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
Time Frame Daily visits, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Dressing sticks to the staples visit 3 Number Analyzed 1 participants
0
   0.0%
Dressing sticks to the staples visit 5 Number Analyzed 3 participants
0
   0.0%
Dressing sticks to the staples visit 6 Number Analyzed 20 participants
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Bleeding Caused by Dressing Removal
Hide Description Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
Time Frame Daily visits, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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..
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Bleeding caused by the dressing removal visit 3 Number Analyzed 0 participants
0
Bleeding caused by the dressing removal visit 5 Number Analyzed 0 participants
0
Bleeding caused by the dressing removal visit 6 Number Analyzed 2 participants
0
   0.0%
5.Secondary Outcome
Title Participants' Dressing Wear Time (Days)
Hide Description The number of days the dressing can stay on are evaluated
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: days
6.35  (1.57)
6.Secondary Outcome
Title Number of Dressing Changes Per Subject
Hide Description To evaluate the number of dressing changes per subject
Time Frame Daily visits, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: Number of dressing changes per subject
1.00  (0.00)
7.Secondary Outcome
Title Evaluation of the Dressing Capacity of Handling Blood
Hide Description Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.
Time Frame Daily visits, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Poor visit 3 Number Analyzed 1 participants
0
   0.0%
Poor visit 5 Number Analyzed 3 participants
0
   0.0%
Poor visit 6 Number Analyzed 20 participants
0
   0.0%
Good visit 3 Number Analyzed 1 participants
0
   0.0%
Good visit 5 Number Analyzed 3 participants
0
   0.0%
Good visit 6 Number Analyzed 20 participants
0
   0.0%
Very good visit 3 Number Analyzed 1 participants
0
   0.0%
Very good visit 5 Number Analyzed 3 participants
0
   0.0%
Very good visit 6 Number Analyzed 20 participants
0
   0.0%
Excellent visit 3 Number Analyzed 1 participants
0
   0.0%
Excellent visit 5 Number Analyzed 3 participants
3
 100.0%
Excellent visit 6 Number Analyzed 20 participants
19
  95.0%
Not applicable visit 6 Number Analyzed 20 participants
1
   5.0%
8.Secondary Outcome
Title Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)
Hide Description

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

Time Frame Daily visits, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title The Study Group
Hide Arm/Group Description:
Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
3
  14.3%
Time Frame Average of one Week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title The Study Group
Hide Arm/Group Description Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
All-Cause Mortality
The Study Group
Affected / at Risk (%)
Total   0/21 (0.00%)    
Hide Serious Adverse Events
The Study Group
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
The Study Group
Affected / at Risk (%) # Events
Total   1/21 (4.76%)    
Skin and subcutaneous tissue disorders   
Redness at border of derssing  [1]  1/21 (4.76%)  1
Indicates events were collected by systematic assessment
[1]
Study subject had a distinctive border of redness where the silicone border was present. Subject denied any itching or pain at the incision site, but the PI confirmed it was an AE with a possible relation ADE.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Research Director
Organization: Mölnlycke Health Care
Phone: +46 31 722 30 00
EMail: info@monlycke.com
Layout table for additonal information
Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT03016078    
Other Study ID Numbers: MxB Po Ag 01
First Submitted: January 4, 2017
First Posted: January 10, 2017
Results First Submitted: January 16, 2018
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018