Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04422119

Acronym

APOSIT-PTG

Enrollment

150

Registered

2020-06-09

Start date

2018-06-01

Completion date

2022-12-31

Last updated

2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Disease, Surgical Wound

Keywords

Surgical wound healing, knee arthroplasty, postoperative dressings

Brief summary

The aim of the study is: to evaluate the efficacy of two post-operative dressings in the management of the surgical wounds in patients who received a knee prosthesis

Detailed description

This was a randomised, controlled, clinical trial on patients who received a primary knee prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac. The control group received standard treatment with povidone-iodine and a gauze dressing with plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the characteristics of the surgical wound, patient reported comfort and adaptability according to the physiotherapist. Secondary outcome measures were: the clinical status and quality of life level according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical significance of 5%.

Interventions

PROCEDUREMulti-Foam dressing

Application of a multi-layer foam dressing with Safetac in surgical wound

PROCEDUREUsual care

Care of surgical wound with povidone-iodine and a gauze dressing with plaster.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Surgical intervention of total primary knee prosthesis * Informed consent approved and signed by participants.

Exclusion criteria

* Sensitivity or allergy to study dressings

Design outcomes

Primary

Measure	Time frame	Description
Change in number of dressing changes	From fist day post-surgery to 7th postoperative day	Number of dressing applications to the patients required

Secondary

Measure	Time frame	Description
Change in patient comfort	From fist day post-surgery to 7th postoperative day	Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)

Countries

Spain

Contacts

Primary ContactSergio Alonso-Fernández, RN,MSN,PhD

salonso.germanstrias@gencat.cat0034934978437

Backup ContactAntonia Salmerón-Ramírez, RN

asalmeronr.germanstrias@gencat.cat0034695560386

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026