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

Arthroplasties, Knee Replacement Clinical Trial

Official title:

A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016078
• Other study ID #: MxB Po Ag 01
• Status: Completed
• Phase: N/A
• First received: January 4, 2017
• Last updated: February 13, 2018
• Start date: February 1, 2017
• Est. completion date: April 7, 2017

Study information

• Verified date: February 2018
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.

Description:

This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA).

The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 7, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Available for a follow-up visit including dressing change 7 days after surgery

3. Plan for elective primary hip or knee arthroplasty

4. Plan for incision size =18 cm

5. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form

6. Undergoing elective primary arthroplasty of the hip or knee.

Exclusion Criteria

1. Known allergy/hypersensitivity to any of the components of the dressing

2. Multi-trauma

3. Undergoing arthroplasty due to tumor

4. Previous incision at the same knee or same side of the hip

5. Wound at the surgical site prior to surgery

6. Neurological deficit of operated side (hemiplegia, etc.)

7. Documented skin disease at time of enrollment, as judged by the investigator

8. Previously enrolled in the present investigation

9. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator

10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)

11. Dressing size does not fit the incision area (>18 cm)

12. Complications that would increase wound risks if investigational dressing is applied

Related Conditions & MeSH terms

• Arthroplasties, Hip Replacement
• Arthroplasties, Knee Replacement

Intervention

Device:
• Mepilex Border Post-Op Ag
To investigate if there was any skin damage under the dressing from operation day to last visit.

Locations

Country	Name	City	State
United States	The CORE Institute Gilbert	Gilbert	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Damage to the Incision and Surrounding Skin	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	Daily visits, up to 7 days
Secondary	Number of Participants With Leakage of the Dressing	Nurse/ Investigator evaluate: Leakage (No/Yes)	Daily visits, up to 7 days
Secondary	Number of Participants With Dressing Sticking to the Staples/Sutures	Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)	Daily visits, up to 7 days
Secondary	Number of Participants With Bleeding Caused by Dressing Removal	Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)	Daily visits, up to 7 days
Secondary	Participants' Dressing Wear Time (Days)	The number of days the dressing can stay on are evaluated	7 days
Secondary	Number of Dressing Changes Per Subject	To evaluate the number of dressing changes per subject	Daily visits, up to 7 days
Secondary	Evaluation of the Dressing Capacity of Handling Blood	Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.	Daily visits, up to 7 days
Secondary	Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)	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	Daily visits, up to 7 days