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| Name | Class |
|---|---|
| Fundació Parc Taulí | UNKNOWN |
| Department of Health, Generalitat de Catalunya | OTHER_GOV |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional dressing | Active Comparator | The conventional dressing (sterile gauzes) will be applied |
|
| Aquacel Surgical® | Experimental | Postoperative sterile dressing composed by non-woven inner pad (in contact with wound) Technology Hydrofiber® formed from sodium carboxymethylcellulose |
|
| Mepilex Border post-op® | Experimental | Flexible absorbent all-in-one post-op dressing, super-absorbent fibres for high and fast absorption with optimised retention. |
|
| Opsite post-op visible® | Experimental | Adhesive dressing with absorbent foam in the form of a grid to visualize the wound without lifting the dressing |
|
| Urgotul ABSORB border silicona® | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquacel Surgical® | Device | Measuring the skin integrity with each dressing and the patient satisfaction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporació Sanitaria Parc Taulí | Sabadell | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25418436 | Background | 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. | |
| 16301916 | Background | 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. |
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| 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 dressing | Device | Measuring the skin integrity with each dressing and the patient satisfaction |
|
| 21278635 | Background | 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. |
| 15855378 | Background | 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. |
| Background | 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. |
| 25818940 | Background | 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. |
| Background | 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. |
| 14563793 | Background | 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. |
| 22405132 | Background | 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. |
| 26372751 | Background | 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. |
| 23118400 | Background | 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. |
| 29976227 | Derived | 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. |