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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Occlusive Dressings Nursing Knee Surgery Hip Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional dressing

The conventional dressing (sterile gauzes) will be applied

Group Type ACTIVE_COMPARATOR

Conventional dressing

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Aquacel Surgical®

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Mepilex Border post-op®

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Opsite post-op visible®

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Urgotul ABSORB border silicona®

Intervention Type DEVICE

Measuring the skin integrity with each dressing and the patient satisfaction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aquacel Surgical®

Measuring the skin integrity with each dressing and the patient satisfaction

Intervention Type DEVICE

Mepilex Border post-op®

Measuring the skin integrity with each dressing and the patient satisfaction

Intervention Type DEVICE

Opsite post-op visible®

Measuring the skin integrity with each dressing and the patient satisfaction

Intervention Type DEVICE

Urgotul ABSORB border silicona®

Measuring the skin integrity with each dressing and the patient satisfaction

Intervention Type DEVICE

Conventional dressing

Measuring the skin integrity with each dressing and the patient satisfaction

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundació Parc Taulí

UNKNOWN

Sponsor Role collaborator

Department of Health, Generalitat de Catalunya

OTHER_GOV

Sponsor Role collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maria Lopez-Parra

RN MSU Bioethics MSU Education and ICT

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25418436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16301916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21278635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15855378 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 25818940 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 14563793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22405132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26372751 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23118400 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29976227 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENF_APO_2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Post Market Clinical Follow-up Study
NCT01841567 COMPLETED PHASE4
HIP-STITCH (Wound Recovery After THA)
NCT06275776 RECRUITING NA