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

Nursing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190447
• Other study ID #: ENF_APO_2017
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: December 31, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Surgery
• Knee Surgery
• Nursing
• Occlusive Dressings

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	Corporació Sanitaria Parc Taulí	Sabadell	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Department of Health, Generalitat de Catalunya, Fundació Parc Taulí

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Collins A. Does the postoperative dressing regime affect wound healing after hip or knee arthroplasty? J Wound Care. 2011 Jan;20(1):11-6. Review. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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