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

Primary Purpose

Hip Surgery Corrective, Knee Injuries

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Active Comparator: Aquacel Surgical
Experimental: Mepilex Border Post-Op
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Surgery Corrective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Gent, Belgium
  • Medisch Centrum Latem
  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Device Aquacel Surgical

Device Mepilex Border Post-Op

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Dressings Adherence to the Staples/Sutures
Dressings adherence to the staples/sutures? Yes/No
Itching Feeling Under the Dressing
Itching feeling under the dressing? Yes/No
Patients Satisfaction With Wearing the Dressing
4 point rating scale ( poor, good, very good,excellent)
Nurses/Doctors Satisfaction With Applying the Dressing
4 point rating scale ( poor, good, very good,excellent)
Patients Mobility After Operation
4 point rating scale ( poor, good, very good,excellent)
Local/Systemic Infection
Local/systemic infection? Yes/No
Pain Level Before and During Dressing Removal
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.

Full Information

First Posted
December 11, 2015
Last Updated
April 3, 2019
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT02653183
Brief Title
Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings
Acronym
MxBPo02
Official Title
A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Surgery Corrective, Knee Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device Aquacel Surgical
Arm Type
Active Comparator
Arm 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.
Arm Title
Device Mepilex Border Post-Op
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Active Comparator: Aquacel Surgical
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Experimental: Mepilex Border Post-Op
Intervention Description
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 Outcome Measure Information:
Title
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
Description
Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).
Time Frame
0-5 days
Secondary Outcome Measure Information:
Title
Dressings Adherence to the Staples/Sutures
Description
Dressings adherence to the staples/sutures? Yes/No
Time Frame
0-5 days
Title
Itching Feeling Under the Dressing
Description
Itching feeling under the dressing? Yes/No
Time Frame
0-5 days
Title
Patients Satisfaction With Wearing the Dressing
Description
4 point rating scale ( poor, good, very good,excellent)
Time Frame
0-5 days
Title
Nurses/Doctors Satisfaction With Applying the Dressing
Description
4 point rating scale ( poor, good, very good,excellent)
Time Frame
0-5 days
Title
Patients Mobility After Operation
Description
4 point rating scale ( poor, good, very good,excellent)
Time Frame
0-5 days
Title
Local/Systemic Infection
Description
Local/systemic infection? Yes/No
Time Frame
0-5 days
Title
Pain Level Before and During Dressing Removal
Description
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.
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 1. 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
Facility Information:
Facility Name
University Hospital Gent, Belgium
City
Gent
ZIP/Postal Code
9000 Gent
Country
Belgium
Facility Name
Medisch Centrum Latem
City
Sint-Martens-Latem
ZIP/Postal Code
9830
Country
Belgium
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

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