Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01261858 |
| Other study ID # |
C/10/600 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
December 15, 2010 |
| Last updated |
December 22, 2010 |
| Start date |
February 2011 |
| Est. completion date |
January 2013 |
Study information
| Verified date |
November 2010 |
| Source |
National University Heart Centre, Singapore |
| Contact |
Michael G Caleb, FRCS, FAMS |
| Phone |
+6567725217 |
| Email |
michael_george_caleb[@]nuhs.edu.sg |
| Is FDA regulated |
No |
| Health authority |
Singapore: Domain Specific Review Boards |
| Study type |
Interventional
|
Clinical Trial Summary
Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG)
in patients undergoing surgery for coronary artery disease. Given the increasing risk
profile of contemporary cardiac surgery patients, sternal complications are subject to
increase concomitantly. Despite advances in many areas of cardiac surgical procedures,
innovation in sternal closure technique has been lacking and postoperative complications
remain. In this study, the investigators aim to assess the effectiveness of using a novel
osteoconductive biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an
adjunct to conventional sternal closure in post CABG patients having median sternotomy.
The outcomes of interest for this study will include: pain, discomfort, lung function, wound
healing and analgesic use. The investigators assume that the use of KryptoniteTM will
decrease postoperative pain leading to improvement in postoperative lung function. This may
also lead to improvement in patient recovery and decrease in postoperative complications.
The investigators will undertake a single-blinded randomized, controlled study consisting of
patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to
either Group A (usual closure with stainless steel wires) or Group B (usual closure with
stainless steel wires plus application of bone cement). Each group will consist of 64
patients in a total of 128 patients. Lung function data using a spirometer will be collected
preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data
will be collected on the 1st to 5th postoperative days.
Description:
Procedure Research assistants will be dedicated to participant recruitment, data collection,
and assessment of sternal wounds. Upon admission, or scheduling for surgery, consecutive
CABG surgery patients who will have median sternotomy will be approached by a research
assistant for preoperative screening (to determine eligibility for the study). Thereafter,
informed consent will be sought to examine their recovery for a period of approximately 16
post-operative weeks.
When undertaking the clinical trial, randomization of the participants will be achieved
using an opaque envelope. Envelopes will be kept at the operation theatre and will be opened
by a nurse or the surgeon prior to surgery. This envelope will also contain a data
collection form to be completed by the surgeons (regarding bone quality, sternotomy, and
number of sternal wires).
Following surgery, blinded research assistants will collect pain data from the participants
on the 1st to 5th postoperative days. These will be measured using a 10-point numeric rating
scale. The scales will be anchored with descriptors 0=none, 10=worst. These data will be
collected at rest and after coughing. Lung function data (FEV1.0, FVC) will be collected
using a bedside spirometer on the 3rd and 5th postoperative days. Other relevant clinical
data (e.g., age, grafts used for and nature of surgery, analgesic use, other complications,
length of stay) will be collected through a health record audit.
Once the participants are discharged, data collection will be done when they return to the
clinic for follow-ups.
Additional Outcomes Other outcomes that will be monitored will include: postoperative death
within 6 weeks, abnormal prolongation in wound healing, length of ICU stay, length of
hospital stay, postoperative pleural effusion, necessity to evacuate effusion, atelectasis,
pneumonia, reoperation requiring sternal reentry, sternal dehiscence, wound infection
(superficial or deep), mediastinitis, amount of analgesia, and all other causes of
morbidity.
Sample Size There is not much information prior to this study. It has been assumed that the
mean differences for the changes in FEV1.0, FVC and pains score at 5 days after surgery
between bone cement and control groups to be 15% and the standard deviation to be 25%
respectively. With these assumptions, a two-sided test, overall level of significance at 5%
and power of 80%, the number of patients that is needed to be enrolled in this study is 64
patients per group after accounting that there will be 1% chance that the patient may have
some major postoperative complication that will prevent the patient from being extubated at
5 days after surgery. The total number of patients that need to be recruited in this study
is 128 patients.
Data Collection Participants will be recruited and in-hospital data collected by research
assistants hired for this study. Staff nurses in the wards will also collect in-hospital
data. They will be trained to use the study questionnaires and measures. Once patients are
discharged from the hospital, the assistants will also follow-up in the outpatient clinic.
Data Analysis For this study, the investigators wish to assess the effectiveness of
KryptoniteTM on pain, and change in postoperative lung function using spirometry.
Although the investigators are interested in the outcomes over time, the effectiveness of
the intervention during the acute period postoperatively as well as 6 postoperative week
will be of greatest interest. In order to investigate the difference in the percentage
change in FEV1.0, FVC and pain score at 5 days after surgery between bone cement and control
groups, 2 sample t-test will be carried out respectively if normality and homogeneity of
variance assumptions are met; otherwise, the Mann-Whitney U test will be used respectively.
The association between postoperative death in the early period and surgery type group (bone
cement or control group) will be evaluated using Chi-Square test if the assumptions for the
Chi-Square test are met; otherwise, Fisher's Exact test will be carried out. Other outcomes
that are monitored will be summarized by the surgery type group using descriptive
statistics. All the analyses will be performed using PASW Statistics 18 (SPSS Inc., Chicago,
IL, USA).
SAFETY
Safety, particularly related to sternal union and wound healing, are of major importance in
this study. In particular, sternal union will be monitored for all patients by visual
inspection. All participants will undergo a visual inspection and palpation of their
sternum, by the team doctors and nurses, regularly throughout the course of this study.
Should any concerns arise with the sternum or wound healing, a digital photograph of the
sternum (using appropriate draping for patient privacy) may be taken, and referred to
his/her consultant surgeon in charge. The photographs will be used to assist in documenting
the healing processes.
DESIGN ISSUES There are a number of important issues that are related to blinding, design
and co-intervention.
Addressing Issues of Observer Blinding l All those collecting data will be trained
rigorously in the standardized study procedures and use of the questionnaires and measures.
l The nature of some of the data to be collected is only the patient's opinion/response.
l A manual of operations will be developed for research associates' use and assistance with
any question/concerns will be available by telephone at all times.
l Although double blinding is desirable in clinical trial designs to minimize/eliminate
observation bias, it is not possible to blind the surgeon. The data collection members will
be kept blinded regarding the grouping of the participant.
Addressing Issues of Participant Blinding l The outcome measures for this study are
participative in nature, particularly as compared to those often used in clinical trials
research (e.g., mortality/morbidity). Yet, these outcome data are highly relevant to
determining the effectiveness of using a sternal closure technique such as this, in this
particular population. As stated in the project objectives, it is one of our goals to
evaluate the effect of the intervention on pain and discomfort; both of which are important
to the patient.
l A 'placebo' is neither achievable nor feasible. Surgeons involved in participant's care
will not divulge the group to which the participant was assigned.
ETHICAL/SAFETY CONSIDERATIONS
The conduct of this study will conform to the standards of DSRB. Data management will be
undertaken using DSRB standards for maintaining patient confidentiality.
FEASIBILITY Cardiac surgeons at National University Hospital will offer the intervention for
this study. The investigators anticipate it will take approximately 12 months to recruit the
study sample and 4 months thereafter to complete data collection.
