Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty SurgeryNCT01477047
Identification of Risk Factors of Prolonged Wound Healing Following Primary Arthroplasty
An observational study of Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of postoperative infection. Several factors have been associated with delayed wound healing and increased risk of infection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery
- How many people
- 1,500 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to 31 Jul 2018
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.
Who may be able to join
- All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.
Who cannot join
- Not willing to participate.
- Drop out at 3 week follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Risk Factors of Prolonged Wound Healing Following Total Hip and Knee Arthroplasty
Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of postoperative infection. Several factors have been associated with delayed wound healing and increased risk of infection. Namely hypertension, obesity, diabetes, smoking and autoimmune disease have been shown to have a detrimental effect on wound healing. The purpose of this study is to verify those findings and determine additional pharmacological, surgical and patient related factors that may result in prolonged wound drainage, prolonged hospital stay and increased risk of infection
Read the detailed description
Study type: Prospective cohort study. Inclusion criteria: All patients receiving primary total hip or knee replacement surgery at Hvidovre Hospital from January 1st 2012 to December 31st 2014.
Exclusion criteria: none Intervention: none
New hypothesis to be tested:
- Hypertension is associated with prolonged wound drainage and increased risk of infection
- Patients receiving Statin treatment have decreased postoperative wound drainage and decreased risk of infection.
- Patients receiving Bisphosphonate treatment have increased postoperative wound drainage and increased risk of infection.
Measured patient related risk variables: Age, sex, primary OA diagnosis, diabetes, smoking, BMI, alcohol consumption, autoimmune disease and hypertension will all be recorded upon admission of the patient to the hospital. Hypertension will be defined when a patient is diagnosed with HT previously to the surgery, receives medical treatment and have systolic / diastolic BP above 140/90 mmHg upon admission. Patients with normal BP upon admission receiving treatment for HT will be classified as having regulated HT. Patients with elevated BP upon admission without previous HT diagnosis will be classified as having newly diagnosed HT. "Smoking" will de divided into smokers, non-smokers and former smokers. Further on, average number of cigarettes pr day during the last month will be recorded for current smokers.
Measured pharmacological risk variables: Use of statins, bisphosphonates, anticoagulants, NSAID's and corticosteroids on time of admission will be recorded.
Measured surgical risk variables: Surgery time, pneumatic tourniquet time, peroperative blood loss, postoperative decrease in hemoglobin levels, surgical complications, antibiotic and bleeding prophylaxis will be recorded by the surgeon upon completion of the surgery.
Outcome measures: Wound-oozing time, length of hospital stay, wound infections, and surgical revision. Wound will be defined as actively draining if the gauze covering the wound is wet to the edges or if fluid is noted to be originating from the surgical site. The nursing staff will record wound drainage during the hospital stay and the patient will be instructed in self-assessment upon dismissal using patient-diary. Wound drainage will be recorded twice a day: before- and afternoon. All patients are seen in outpatient clinic for staple removal and control of the self -assessment drainage-diary 3 weeks after surgery. Time when the wound appeared dry will be noted. Presence or absence of clinical infection will be noted according to ASEPSIS criteria.
Statistical analysis: Multiple linear regression analysis will be performed to model the effects of the measured risk variables on the time to a dry wound, length of hospital stay and risk of wound infection.
Data collection: All data collection will be anonymous. Patient consent is not required since the study involves evaluation of existing data and records and individual subjects can not be identified either directly or through identifiers linked to the subject. The data collection will be reported to "Datatilsynet".
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving primary hip or knee arthoplasty | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound drainage time
Measured: 3 weeks
Secondary outcomes (1)
Clinical infection
Measured: months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2012
- Primary completion21 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Gromov, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477047
- Sponsor's protocol ID
- 2011-41-6844
- Status last verified
- Jul 2018
- First submitted
- 18 Nov 2011
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors of Prolonged Wound Healing Following Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01477047
- Acronym / sponsor ID
- 2011-41-6844
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of postoperative infection. Several factors have been associated with delayed wound healing and increased risk of infection. Namely hypertension, obesity, diabetes, smoking and autoimmune disease have been shown to have a detrimental effect on wound healing. The purpose of this study is to verify those findings and determine additional pharmacological, surgical and patient related factors that may result in prolonged wound drainage, prolonged hospital stay and increased risk of infection
Detailed description
Study type: Prospective cohort study. Inclusion criteria: All patients receiving primary total hip or knee replacement surgery at Hvidovre Hospital from January 1st 2012 to December 31st 2014.
Exclusion criteria: none Intervention: none
New hypothesis to be tested:
- Hypertension is associated with prolonged wound drainage and increased risk of infection
- Patients receiving Statin treatment have decreased postoperative wound drainage and decreased risk of infection.
- Patients receiving Bisphosphonate treatment have increased postoperative wound drainage and increased risk of infection.
Measured patient related risk variables: Age, sex, primary OA diagnosis, diabetes, smoking, BMI, alcohol consumption, autoimmune disease and hypertension will all be recorded upon admission of the patient to the hospital. Hypertension will be defined when a patient is diagnosed with HT previously to the surgery, receives medical treatment and have systolic / diastolic BP above 140/90 mmHg upon admission. Patients with normal BP upon admission receiving treatment for HT will be classified as having regulated HT. Patients with elevated BP upon admission without previous HT diagnosis will be classified as having newly diagnosed HT. "Smoking" will de divided into smokers, non-smokers and former smokers. Further on, average number of cigarettes pr day during the last month will be recorded for current smokers.
Measured pharmacological risk variables: Use of statins, bisphosphonates, anticoagulants, NSAID's and corticosteroids on time of admission will be recorded.
Measured surgical risk variables: Surgery time, pneumatic tourniquet time, peroperative blood loss, postoperative decrease in hemoglobin levels, surgical complications, antibiotic and bleeding prophylaxis will be recorded by the surgeon upon completion of the surgery.
Outcome measures: Wound-oozing time, length of hospital stay, wound infections, and surgical revision. Wound will be defined as actively draining if the gauze covering the wound is wet to the edges or if fluid is noted to be originating from the surgical site. The nursing staff will record wound drainage during the hospital stay and the patient will be instructed in self-assessment upon dismissal using patient-diary. Wound drainage will be recorded twice a day: before- and afternoon. All patients are seen in outpatient clinic for staple removal and control of the self -assessment drainage-diary 3 weeks after surgery. Time when the wound appeared dry will be noted. Presence or absence of clinical infection will be noted according to ASEPSIS criteria.
Statistical analysis: Multiple linear regression analysis will be performed to model the effects of the measured risk variables on the time to a dry wound, length of hospital stay and risk of wound infection.
Data collection: All data collection will be anonymous. Patient consent is not required since the study involves evaluation of existing data and records and individual subjects can not be identified either directly or through identifiers linked to the subject. The data collection will be reported to "Datatilsynet".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving primary hip or knee arthoplasty | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.
Key inclusion criteria (1 listed)
- All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.
Key exclusion criteria (2 listed)
- Not willing to participate.
- Drop out at 3 week follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound drainage time
Time frame: 3 weeks
1 secondary outcome
Clinical infection
Time frame: months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Aug 2018. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound drainage time (time frame: 3 weeks). 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 1 Aug 2018.