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Occlusive DressingsNCT03190447

Wich is the Best Dressing in Wounds by Primary Surgery of THA and / or TKA?

A study testing Aquacel Surgical®, Mepilex Border post-op® and Opsite post-op visible® in people with Occlusive Dressings and Nursing, run by Corporacion Parc Tauli at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. Currently, in Corporació PT after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Occlusive Dressings, Nursing, Knee Surgery
What is being tested?
Aquacel Surgical®, Mepilex Border post-op® and Opsite post-op visible®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
1 siteSpain
Study dates
20 Apr 2017to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients older than 18 years
  • operated on primary TKA and THA in the fast track circuit
  • adequate cognitive ability.

Who cannot join

  • damaged skin
  • no self-care capacity or caregiver
  • inadequate cognitive ability to consent freely
  • patients who will not undergo "fast track" surgery

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona

Other trials in Spain

About this study

Official title: Randomized Clinical Trial Comparing 5 Types Dressings in Wounds by Primary Orthopedic Surgery of Total Hip Arthroplasty and / or Knee

Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. Currently, in Corporació PT after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. In many cases the appearance of blistering caused by the use of these conventional dressings is observed, which increases the risk of infection, pain and the final cost of the procedure. There are other types of dressings that could improve these aspects but comparative data are not currently available. Main objective: to identify the dressing that better preserves the integrity of the skin.

Design: Prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (TKA and THA).

Read more

Secondary Objectives: To identify the dressing that provides greater advantages and minor inconveniences in TKA and THA surgery.

Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110 patients

Being tested
Aquacel Surgical®, Mepilex Border post-op®, Opsite post-op visible®, Urgotul ABSORB border silicona®, Conventional dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aquacel Surgical®Device

    Measuring the skin integrity with each dressing and the patient satisfaction

  • Mepilex Border post-op®Device

    Measuring the skin integrity with each dressing and the patient satisfaction

  • Opsite post-op visible®Device

    Measuring the skin integrity with each dressing and the patient satisfaction

  • Urgotul ABSORB border silicona®Device

    Measuring the skin integrity with each dressing and the patient satisfaction

  • Conventional dressingDevice

    Measuring the skin integrity with each dressing and the patient satisfaction

Study groups in NCT03190447
Study groupRoleWhat they receive
Conventional dressingActive comparatorThe conventional dressing (sterile gauzes) will be applied
Receives: Device: Conventional dressing
Aquacel Surgical®ExperimentalPostoperative sterile dressing composed by non-woven inner pad (in contact with wound) Technology Hydrofiber® formed from sodium carboxymethylcellulose
Receives: Device: Aquacel Surgical®
Mepilex Border post-op®ExperimentalFlexible absorbent all-in-one post-op dressing, super-absorbent fibres for high and fast absorption with optimised retention.
Receives: Device: Mepilex Border post-op®
Opsite post-op visible®ExperimentalAdhesive dressing with absorbent foam in the form of a grid to visualize the wound without lifting the dressing
Receives: Device: Opsite post-op visible®
Urgotul ABSORB border silicona®ExperimentalA soft-adherent TLC (Technology Lipido-Colloid) layer (polymers and hydrocolloid particles) combined with an absorbent polyurethane foam pad and a highly absorbent layer. A vapour permeable waterproof outer film with silicone adhesive on the edges.
Receives: Device: Urgotul ABSORB border silicona®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin integrity

    Skin integrity is a composite endpoint including absence of any of the following items: blisters, erosion, erythema, maceration, swelling, wound dehiscence, purulent exudate) in the area of the surgical wound, measured by wound inspection

    Measured: 2 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study start20 Apr 2017
  3. Primary completion30 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
560 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03190447
Sponsor's protocol ID
ENF_APO_2017
Status last verified
Mar 2020
First submitted
6 Jun 2017
Last updated
9 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abboud EC, Settle JC, Legare TB, Marcet JE, Barillo DJ, Sanchez JE. Silver-based dressings for the reduction of surgical site infection: review of current experience and recommendation for future studies. Burns. 2014 Dec;40 Suppl 1:S30-9. doi: 10.1016/j.burns.2014.09.011.

    PubMed 25418436

  • Aindow D, Butcher M. Films or fabrics: is it time to re-appraise postoperative dressings? Br J Nurs. 2005 Oct 27-Nov 9;14(19):S15-6, S18, S20. doi: 10.12968/bjon.2005.14.Sup5.19953.

    PubMed 16301916

  • Collins A. Does the postoperative dressing regime affect wound healing after hip or knee arthroplasty? J Wound Care. 2011 Jan;20(1):11-6. doi: 10.12968/jowc.2011.20.1.11.

    PubMed 21278635

  • Davies R, Holt N, Nayagam S. The care of pin sites with external fixation. J Bone Joint Surg Br. 2005 May;87(5):716-9. doi: 10.1302/0301-620X.87B5.15623.

    PubMed 15855378

  • Dillon JM, Clarke JV, Deakin AH, Nico AC and Kinninmonth AWG. Correlation of total knee replacement surgery wound dynamic morphology and dressing material properties. Journal of Biomechanics 40(S2), 2007.

  • Andrew Glennie R, Dea N, Street JT. Dressings and drains in posterior spine surgery and their effect on wound complications. J Clin Neurosci. 2015 Jul;22(7):1081-7. doi: 10.1016/j.jocn.2015.01.009. Epub 2015 Mar 25.

    PubMed 25818940

  • Jester R, Russell L, Fell S, Williams S, Prest C. A one hospital study of the effect of wound dressings and other related factors on skin blistering following total hip and knee arthroplasty. Journal of Orthopaedic Nursing 4:71-77, 2000.

  • Koval KJ, Egol KA, Polatsch DB, Baskies MA, Homman JP, Hiebert RN. Tape blisters following hip surgery. A prospective, randomized study of two types of tape. J Bone Joint Surg Am. 2003 Oct;85(10):1884-7.

    PubMed 14563793

  • Ousey K, Gillibrand W, Stephenson J. Achieving international consensus for the prevention of orthopaedic wound blistering: results of a Delphi survey. Int Wound J. 2013 Apr;10(2):177-84. doi: 10.1111/j.1742-481X.2012.00965.x. Epub 2012 Mar 8.

    PubMed 22405132

  • Springer BD, Beaver WB, Griffin WL, Mason JB, Odum SM. Role of Surgical Dressings in Total Joint Arthroplasty: A Randomized Controlled Trial. Am J Orthop (Belle Mead NJ). 2015 Sep;44(9):415-20.

    PubMed 26372751

  • Vince KG. Wound closure: healing the collateral damage. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):126-33. doi: 10.1302/0301-620X.94B11.30792.

    PubMed 23118400

  • Lopez-Parra M, Gil-Rey D, Lopez-Gonzalez E, Gonzalez-Rodriguez EM, Simo-Sanchez I, Zamora-Carmona F, Roqueta-Andreu L, Arizu-Puigvert M, Abril-Sabater D, Moreno-Alvarez A, Lopez-Bonet A, Lopez-Hidalgo G, Costa-Ventura H, Garcia-Pardo L, Rico-Liberato M, Garcia-Borras M, Arnal-Leris MT, Sianes-Gallen M, Vives R. Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2018 Jul 5;19(1):357. doi: 10.1186/s13063-018-2755-8.

    PubMed 29976227

Questions about this trial

What is this clinical trial studying?

A study testing Aquacel Surgical®, Mepilex Border post-op® and Opsite post-op visible® in people with Occlusive Dressings and Nursing, run by Corporacion Parc Tauli at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin integrity (time frame: 2 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03190447, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.

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