Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00582998 |
| Other study ID # |
F010316003 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2001 |
| Est. completion date |
March 2007 |
Study information
| Verified date |
May 2019 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This project is designed as a prospective, randomized, comparative study evaluating the use
of a negative pressure vacuum device in treating soft tissue injuries and the surgical
incision following open reduction and internal fixation of calcaneus, tibial plateau, and
pilon fractures.
Description:
Patients who have a calcaneus fracture requiring open reduction and internal fixation through
a lateral approach and who give informed consent to enter the study will be randomized into
two groups. Randomization will be stratified for each of the three fracture types. Group A
will be patients treated with daily dressing changes and wound evaluations beginning on post
operative day 1. Group B patients will have a VAC device placed in the operating room, with
the first post-operative wound evaluation taking place 48 hours post-op. If at the first
post-operative evaluation there is marked drainage, the VAC device will be replaced with
re-evaluation approximately 48 hours later.
The outcome variables consist of the number of days and amount of wound drainage, incidence
of wound breakdown, incidence of flap coverage, incidence of infection, return to the
operating room for repeat irrigation and debridement , the need for repeat wound closure, and
any other intraoperative and postoperative complications recorded in medical record and on
the study data collection form.
Patients who have a tibial plateau fracture requiring open reduction and internal fixation
and who give informed consent to enter the study will be randomized into two groups. Group A
will be patients treated with daily dressing changes and wound evaluations beginning on post
operative day 2. Group B patients will have a VAC device placed in the operating room, with
the first post-operative wound evaluation taking place 48 hours post-op. If at the first
post-operative evaluation there is marked drainage the VAC device will be replaced with
re-evaluation approximately 48 hours later. Patients with open tibial plateau fractures will
be included in both groups A and B but will be sub-stratified within each group.
The outcome variables consist of the number of days and amount of wound drainage, incidence
of wound breakdown, incidence of flap coverage, incidence of infection, return to the
operating room for repeat irrigation and debridement , the need for repeat wound closure, and
any other intraoperative and postoperative complications recorded in medical record and on
the study data collection form.
Patients who have a pilon fracture requiring open reduction and internal fixation and who
give informed consent to enter the study will be randomized into two groups. Group A will be
patients treated with daily dressing changes and wound evaluations beginning on post
operative day 2. Group B patients will have a VAC device placed in the operating room, with
the first post-operative wound evaluation taking place 48 hours post-op. If at the first
post-operative evaluation there is marked drainage the VAC device will be replaced with
re-evaluation approximately 48 hours later. Patients with open pilon fractures will be
included in both groups A and B but will be sub-stratified within each group.
The outcome variables consist of the number of days and amount of wound drainage, incidence
of wound dehiscence, incidence of flap coverage, incidence of infection, return to the
operating room for repeat irrigation and debridement, the need for repeat wound closure, and
any other intraoperative and postoperative complications recorded in medical record and on
the study data collection form. All patients will have their total lymphocyte counts and
their albumin levels recorded on admission to document their nutritional status and ability
to heal wounds.
Clinical photographs of the wounds will be taken with a digital camera at the time of
admission to the study, and during each subsequent trip to the operating room. We will also
record the injury severity score for all multiple trauma patients recorded at the time of
injury in the medical record and on the study data collection form. The soft tissue score,
according to the Tscherne classification for closed injuries or according to the Gustillo and
Anderson classification for open injuries will also be recorded, for all multiple trauma
patients, at the time of injury in the medical record and on the study data collection form.
The effects will be measured by clinical examination and will be augmented with culture data
for any wounds that require surgical intervention. All patients in the Intensive Care Units
will have daily weights, fluid balances, and nutritional intake recorded per ICU protocol.
Resuscitation data, including total fluids, blood products, and base deficit will be
recorded. Fluids and blood utilization in the OR will also be documented.
The following methods and tools will be used to document study data points: intraoperative
and postoperative adverse device effects recorded in the medical record and on the study data
collection form, daily wound drainage as documented on rounds and in the medical record,
admission total lymphocyte count and serum albumin levels, clinical evidence of infection and
supplementary lab data. All of this data will be documented on the study data collection
form. Patients will be followed clinically for 12 months, documenting any complications that
occur with the wound (infection, dehiscence, etc…) on the study data collection form. The
soft tissue score according to Tscherne classification for closed injuries, and the Gustillo
and Anderson score for open injuries, will be recorded in the medical record and on the study
data collection form.
Data will be collected and entered into EXCEL spreadsheets with double keying for quality
control purposes and managed by the Department of Orthopaedic Surgery at the University of
Alabama at Birmingham (UAB). After data entry is complete, the file(s) will be copied to
diskette and delivered to the UAB Biostatistics statistician for analysis and report
generation. The analysis will involve simple descriptive statistics (means, standard
deviations, proportions) to assure balance of the treatment groups with respect to relevant
variables. T-test will be used to compare the mean times to wound closure as well as the need
for surgical debridement of the wound. Analysis of covariance will be performed if there are
variables that require adjustment. Growth curve analysis (survival models) and Cox regression
procedures will be used to compare the rates of wound closure between the two groups.
Assumption of proportional hazards in the model will be verified before attempting Cox
regression procedures. P-values will be computed using a Mann-Whitney U test for
non-parametric data.
