Surgical WoundAPOSIT-PTGNCT04422119
Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
A study testing Multi-Foam dressing in people with Surgical Wound and Knee Disease, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Knee Disease
- What is being tested?
- Multi-Foam dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical intervention of total primary knee prosthesis
- Informed consent approved and signed by participants.
Who cannot join
- Sensitivity or allergy to study dressings
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Sergio Alonso-Fernández, RN,MSN,PhD, 0034934978437, salonso.germanstrias@gencat.cat
Antonia Salmerón-Ramírez, RN, 0034934973497
About this study
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
Read the 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%.
- Conditions
- Surgical Wound, Knee Disease
- Being tested
- Multi-Foam dressing, Usual care
- Keywords
- Surgical wound healing, knee arthroplasty, postoperative dressings
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Foam dressingProcedure or surgery
Application of a multi-layer foam dressing with Safetac in surgical wound
Usual careProcedure or surgery
Care of surgical wound with povidone-iodine and a gauze dressing with plaster.
| Study group | Role | What they receive |
|---|---|---|
| Multi-layer foam dressing | Experimental | Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound Receives: Procedure: Multi-Foam dressing |
| Usual care | Active comparator | Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of dressing changes
Number of dressing applications to the patients required
Measured: From fist day post-surgery to 7th postoperative day
Secondary outcomes (1)
Change in patient comfort
Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)
Measured: From fist day post-surgery to 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
- Investigators
- Antonia Salmerón-Ramírez, RN, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422119
- Sponsor's protocol ID
- AC-16-016-CEIMPS
- Acronym
- APOSIT-PTG
- Status last verified
- Jun 2020
- First submitted
- 3 Dec 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
- ClinicalTrials.gov ID
- NCT04422119
- Acronym / sponsor ID
- APOSIT-PTG / AC-16-016-CEIMPS
- Conditions
- Surgical Wound, Knee Disease
- Keywords
- Surgical wound healing, knee arthroplasty, postoperative dressings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-layer foam dressing | Experimental | Procedure: Multi-Foam dressingPatients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound |
| Usual care | Active comparator | Procedure: Usual carePatients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical intervention of total primary knee prosthesis
- Informed consent approved and signed by participants.
Key exclusion criteria (1 listed)
- Sensitivity or allergy to study dressings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Foam dressingApplication of a multi-layer foam dressing with Safetac in surgical wound | Procedure or surgery | Multi-layer foam dressing |
| Usual careCare of surgical wound with povidone-iodine and a gauze dressing with plaster. | Procedure or surgery | Usual care |
Primary outcome
Change in number of dressing changes
Time frame: From fist day post-surgery to 7th postoperative day
Number of dressing applications to the patients required
1 secondary outcome
Change in patient comfort
Time frame: From fist day post-surgery to 7th postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Salmerón-Ramírez, RN principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Foam dressing in people with Surgical Wound and Knee Disease, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Alonso-Fernández, RN,MSN,PhD (0034934978437, salonso.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of dressing changes (time frame: From fist day post-surgery to 7th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.