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NCT Number: NCT02653183

Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

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

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Key information

Conditions

Hip Surgery Corrective Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Gent, Belgium, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

, enrolment phase

  • 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

Inclusion criteria

, randomization phase

  • Undergoing elective primary arthroplasty of the hip or knee

Exclusion criteria

,enrolment phase

  • 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.

Exclusion criteria

, randomization phase

  • Dressing size does not fit the incision area, over 18 cm
  • Complications that would increase wound risks if investigation dressing is applied
  • Postoperative drain

Treatment and study plan

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.

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.

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

    Time frame: 0-5 days

    Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).

Secondary outcomes

  1. Dressings Adherence to the Staples/Sutures

    Time frame: 0-5 days

    Dressings adherence to the staples/sutures? Yes/No

  2. Itching Feeling Under the Dressing

    Time frame: 0-5 days

    Itching feeling under the dressing? Yes/No

  3. Patients Satisfaction With Wearing the Dressing

    Time frame: 0-5 days

    4 point rating scale ( poor, good, very good,excellent)

  4. Nurses/Doctors Satisfaction With Applying the Dressing

    Time frame: 0-5 days

    4 point rating scale ( poor, good, very good,excellent)

  5. Patients Mobility After Operation

    Time frame: 0-5 days

    4 point rating scale ( poor, good, very good,excellent)

  6. Local/Systemic Infection

    Time frame: 0-5 days

    Local/systemic infection? Yes/No

  7. Pain Level Before and During Dressing Removal

    Time frame: Day 7

    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.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

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

Acronym: MxBPo02

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2016
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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