N/A
N=103
Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings
Hip Surgery Corrective · Knee Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02653183 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: 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 — 36; 32; 10; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Comparator: Aquacel Surgical (Device); Experimental: Mepilex Border Post-Op (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
36; 32; 10; 11; 0; 1 | — |
| SECONDARY Dressings Adherence to the Staples/Sutures |
53; 50; 0; 0 | — |
| SECONDARY Itching Feeling Under the Dressing |
53; 48; 0; 2 | — |
| SECONDARY Patients Satisfaction With Wearing the Dressing |
0; 1; 13; 19; 22; 24 | — |
| SECONDARY Nurses/Doctors Satisfaction With Applying the Dressing |
2; 2; 13; 35; 17; 12 | — |
| SECONDARY Patients Mobility After Operation |
0; 1; 12; 19; 23; 24 | — |
| SECONDARY Local/Systemic Infection |
53; 50; 0; 0 | — |
| SECONDARY Pain Level Before and During Dressing Removal |
7.8; 4.9; 6.9; 10 | — |
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
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
- 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
Data sourced from ClinicalTrials.gov (NCT02653183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.