Wich is the Best Dressing in Wounds by Primary Surgery of THA and / or TKA?
NCT ID: NCT03190447
Last Updated: 2020-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
560 participants
INTERVENTIONAL
2017-04-20
2019-12-31
Brief Summary
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Design: Prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (TKA and THA).
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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Conventional dressing
The conventional dressing (sterile gauzes) will be applied
Conventional dressing
Measuring the skin integrity with each dressing and the patient satisfaction
Aquacel Surgical®
Postoperative sterile dressing composed by non-woven inner pad (in contact with wound) Technology Hydrofiber® formed from sodium carboxymethylcellulose
Aquacel Surgical®
Measuring the skin integrity with each dressing and the patient satisfaction
Mepilex Border post-op®
Flexible absorbent all-in-one post-op dressing, super-absorbent fibres for high and fast absorption with optimised retention.
Mepilex Border post-op®
Measuring the skin integrity with each dressing and the patient satisfaction
Opsite post-op visible®
Adhesive dressing with absorbent foam in the form of a grid to visualize the wound without lifting the dressing
Opsite post-op visible®
Measuring the skin integrity with each dressing and the patient satisfaction
Urgotul ABSORB border silicona®
A 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.
Urgotul ABSORB border silicona®
Measuring the skin integrity with each dressing and the patient satisfaction
Interventions
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Aquacel Surgical®
Measuring the skin integrity with each dressing and the patient satisfaction
Mepilex Border post-op®
Measuring the skin integrity with each dressing and the patient satisfaction
Opsite post-op visible®
Measuring the skin integrity with each dressing and the patient satisfaction
Urgotul ABSORB border silicona®
Measuring the skin integrity with each dressing and the patient satisfaction
Conventional dressing
Measuring the skin integrity with each dressing and the patient satisfaction
Eligibility Criteria
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Inclusion Criteria
* operated on primary TKA and THA in the fast track circuit
* adequate cognitive ability.
Exclusion Criteria
* no self-care capacity or caregiver
* inadequate cognitive ability to consent freely
* patients who will not undergo "fast track" surgery
18 Years
ALL
No
Sponsors
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Fundació Parc Taulí
UNKNOWN
Department of Health, Generalitat de Catalunya
OTHER_GOV
Corporacion Parc Tauli
OTHER
Responsible Party
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Maria Lopez-Parra
RN MSU Bioethics MSU Education and ICT
Locations
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Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ENF_APO_2017
Identifier Type: -
Identifier Source: org_study_id
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