Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

Knee Injuries Clinical Trial

— MxBPo02  

Official title:

A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653183
• Other study ID #: MxB Po 02
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2017
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.

The secondary objectives are to evaluate:

• the performance of the dressing

• the comfort, conformability and the acceptability of the dressing

• pain before and during dressing removal on the last visit

Description:

A prospective, randomized clinical investigation will be conducted at two to three sites in Belgium and Sweden.

Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation.

100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment randomization. Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in a ratio of 1:1 provided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria, enrolment phase

1. Age = 18 years

2. Have an expected total length of stay of 4 postoperative days or more

3. Plan for elective primary arthroplasty of the hip or knee

4. Plan for incision size > 18 cm

5. Give their written informed consent to participate

Inclusion Criteria, randomization phase

1. Undergoing elective primary arthroplasty of the hip or knee

Exclusion Criteria,enrolment phase

1. Known allergy or hypersensitivity to any of the components of the dressings

2. Multitrauma

3. Undergoing arthroplasty due to tumour

4. Wound at the surgical site prior to surgery

5. Neurological deficit of operated side ,hemiplegia, etc.

6. Documented skin disease at time of enrolment, as judged by the investigator

7. Previously enrolled in the present investigation

8. Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator

9. Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor.

Exclusion Criteria, randomization phase

1. Dressing size does not fit the incision area, over 18 cm

2. Complications that would increase wound risks if investigation dressing is applied

3. Postoperative drain

Related Conditions & MeSH terms

• Hip Surgery Corrective
• Knee Injuries

Intervention

Device:
• Active Comparator: Aquacel Surgical
Post-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days.
• Experimental: Mepilex Border Post-Op
Aquacel Surgical is a sterile, one piece post-operative dressing.Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days.

Locations

Country	Name	City	State
Belgium	University Hospital Gent, Belgium	Gent
Belgium	Medisch Centrum Latem	Sint-Martens-Latem
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Countries where clinical trial is conducted

Belgium,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing	Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).	0-5 days
Secondary	Dressings Adherence to the Staples/Sutures	Dressings adherence to the staples/sutures? Yes/No	0-5 days
Secondary	Itching Feeling Under the Dressing	Itching feeling under the dressing? Yes/No	0-5 days
Secondary	Patients Satisfaction With Wearing the Dressing	4 point rating scale ( poor, good, very good,excellent)	0-5 days
Secondary	Nurses/Doctors Satisfaction With Applying the Dressing	4 point rating scale ( poor, good, very good,excellent)	0-5 days
Secondary	Patients Mobility After Operation	4 point rating scale ( poor, good, very good,excellent)	0-5 days
Secondary	Local/Systemic Infection	Local/systemic infection? Yes/No	0-5 days
Secondary	Pain Level Before and During Dressing Removal	Different adhesive on the dressings, can any difference be identified during dressing removal.; Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable.	Day 7