Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings (MxBPo02)

Molnlycke Health Care

Status: Completed

Conditions: Knee Injuries; Hip Surgery Corrective

Treatments: Device: Active Comparator: Aquacel Surgical; Device: Experimental: Mepilex Border Post-Op

Study type: Interventional

Funder types: Industry

Identifiers

NCT02653183

MxB Po 02

Details and patient eligibility

About

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

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Device Aquacel Surgical

Active Comparator group

Description:

Aquacel Surgical is a sterile, one piece post-operative dressing from Convatec. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days.

Treatment:

Device: Experimental: Mepilex Border Post-Op

Device Mepilex Border Post-Op

Experimental group

Description:

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.

Treatment:

Device: Active Comparator: Aquacel Surgical