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CompletedNCT01477047Updated Aug 1, 2018

Identification of Risk Factors of Prolonged Wound Healing Following Primary Arthroplasty

An observational study in Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-08-01.

Sponsored by Hvidovre University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years to 90 Years
Sex
All
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Study 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. 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:

  1. Hypertension is associated with prolonged wound drainage and increased risk of infection
  2. Patients receiving Statin treatment have decreased postoperative wound drainage and decreased risk of infection.
  3. 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".

02

Conditions studied

  • Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 1,500 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.

Inclusion criteria

  • All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.

Exclusion criteria

Exclusion Criteria:

  • Not willing to participate.
  • Drop out at 3 week follow up.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (actual)

Groups and cohorts

  • Patients receiving primary hip or knee arthoplasty
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What researchers measure

Primary outcomes

  1. Wound drainage time

    Time frame: 3 weeks

Secondary outcomes

  1. Clinical infection

    Time frame: months

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Study locations

1 site
  • Hvidovre Hospital
    Hvidovre, 2650, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01477047
Lead sponsor
Hvidovre University Hospital
Responsible party
Kirill Gromov (MD, PhD, Hvidovre University Hospital) — Principal investigator
First posted
Nov 22, 2011
Start date
Jan 2012
Primary completion
Jul 21, 2018
Completion
Jul 31, 2018
Last update
Aug 1, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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