Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

NCT02653183 | Completed Results

• 1 other identifier: MxB Po 02
• Study Type: interventional
• Target: 118
• Locations: 2 countries
• Sites: 3

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

Conditions

Hip Surgery Corrective; Knee Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Dressings Adherence to the Staples/Sutures

  0-5 days

• Itching Feeling Under the Dressing

  0-5 days

• Patients Satisfaction With Wearing the Dressing

  0-5 days

• Nurses/Doctors Satisfaction With Applying the Dressing

  0-5 days

• Patients Mobility After Operation

  0-5 days

Study Arms (2)

Device Aquacel Surgical

ACTIVE COMPARATOR

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.

Device: Experimental: Mepilex Border Post-Op

Device Mepilex Border Post-Op

EXPERIMENTAL

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.

Device: Active Comparator: Aquacel Surgical

Interventions

Active Comparator: Aquacel Surgical 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.

Device Mepilex Border Post-Op

Experimental: Mepilex Border Post-Op 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 Aquacel Surgical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Have an expected total length of stay of 4 postoperative days or more
• Plan for elective primary arthroplasty of the hip or knee
• Plan for incision size \> 18 cm
• Give their written informed consent to participate
• \. Undergoing elective primary arthroplasty of the hip or knee

You may not qualify if:

• Known allergy or hypersensitivity to any of the components of the dressings
• Multitrauma
• Undergoing arthroplasty due to tumour
• Wound at the surgical site prior to surgery
• Neurological deficit of operated side ,hemiplegia, etc.
• Documented skin disease at time of enrolment, as judged by the investigator
• Previously enrolled in the present investigation
• Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator
• Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor.
• Dressing size does not fit the incision area, over 18 cm
• Complications that would increase wound risks if investigation dressing is applied
• Postoperative drain

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (3)

University Hospital Gent, Belgium

Ghent, 9000 Gent, Belgium

Location

Medisch Centrum Latem

Sint-Martens-Latem, 9830, Belgium

Location

Södersjukhuset

Stockholm, 118 83, Sweden

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Prof. Dr. Hilde Beele
• Organization: Universitair Ziekenhuis Gent

Hilde.Beele@uzgent.be

+32 9 332 21 11

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: January 12, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 1, 2019
• Results First Posted: July 1, 2019

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); SE (1)