Clinical trial NCT01988818: Prospective, Randomized Study of 2 Different Wound Dressings
Official title: A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip-surgery
Knee-surgery
Spinal-surgery
Keywords: wound dressing
silicone
standard wound dressing
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:

* the performance of the dressing
* the comfort, conformability and the acceptability of the dressing
* pain before, during and after dressing removal
* the overall cost regarding dressing wear time, time to do dressing change and personal resources needed

Detailed description: A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.

Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up).

Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).

AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.

Outcome Measures

Primary variable:

• Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).

Secondary variables:

* Other wound complications (i.e. leakage, inflammation, infection)
* Number of dressing changes
* Pain before, during and after dressing removal (VA scale)
* Performance and acceptability of the dressing (4 point rating scale)

Eligibility criteria: Inclusion Criteria:

1. Age ≥18years
2. Have an expected total length of stay of 4 or more days
3. Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
4. Undergoing hip surgery with a standard access
5. Give their written informed consent to participate

Exclusion Criteria:

1. Dressing size does not fit the incision area
2. Known allergy/hypersensitivity to any of the components of the dressing
3. Multi-trauma
4. Undergoing arthroplasty or spine surgery due to tumour or infection?
5. Fractures
6. Wound at the surgical site prior to surgery
7. Neurological deficit of operated side (hemiplegia, etc.)
8. Subject has documented skin disease at time of enrolment, as judged by the investigator

Primary outcomes:
measure: Blistering
timeFrame: 0-6 days
Secondary outcomes:
measure: wound complications
timeFrame: 0-6 days
measure: dressing changes
timeFrame: 0-6 days
measure: pain
timeFrame: 0-6 days
measure: performance and acceptability
timeFrame: 0-6 days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
Study officials:
affiliation: University Hospital of Cologne
name: Jan Bredow, physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bredow J, Hoffmann K, Oppermann J, Hellmich M, Eysel P, Zarghooni K. Evaluation of Absorbent Versus Conventional Wound Dressing. Dtsch Arztebl Int. 2018 Mar 30;115(13):213-219. doi: 10.3238/arztebl.2018.0213.
citation: Bredow J, Oppermann J, Hoffmann K, Hellmich M, Wenk B, Simons M, Eysel P, Zarghooni K. Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial. Trials. 2015 Mar 7;16:81. doi: 10.1186/s13063-015-0599-z.