Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

NCT ID: NCT02653183

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Hip Surgery Corrective; Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Aquacel Surgical

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.

Group Type: ACTIVE_COMPARATOR

Experimental: Mepilex Border Post-Op

Intervention Type: DEVICE

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.

Device Mepilex Border Post-Op

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.

Group Type: EXPERIMENTAL

Active Comparator: Aquacel Surgical

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

1. Undergoing elective primary arthroplasty of the hip or knee

Exclusion Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Gent, Belgium

Ghent, , Belgium

Medisch Centrum Latem

Sint-Martens-Latem, , Belgium

Södersjukhuset

Stockholm, , Sweden

Countries

Belgium; Sweden

Other Identifiers

MxB Po 02

Identifier Type: -

Identifier Source: org_study_id