Clinical trial NCT02653183: Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings
Official title: A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Surgery Corrective
Knee Injuries
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2016-01-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 0-5 days
Secondary outcomes:
measure: Dressings Adherence to the Staples/Sutures
timeFrame: 0-5 days
measure: Itching Feeling Under the Dressing
timeFrame: 0-5 days
measure: Patients Satisfaction With Wearing the Dressing
timeFrame: 0-5 days
measure: Nurses/Doctors Satisfaction With Applying the Dressing
timeFrame: 0-5 days
measure: Patients Mobility After Operation
timeFrame: 0-5 days
measure: Local/Systemic Infection
timeFrame: 0-5 days
measure: Pain Level Before and During Dressing Removal
timeFrame: Day 7
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Gent, Belgium
city: Sint-Martens-Latem
country: Belgium
facility: Medisch Centrum Latem
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
References: