The primary objective of this multicenter, parallel design, prospective, randomized clinical trial, with repeated observations over time, is to compare the clinical, safety, and economic outcomes of V.A.C.® Therapy and SCWT based on an open…
ID
Source
Brief title
Condition
- Other condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Health condition
onderhuids abdominale wondhelingsstoornis zonder fasciedehiscentie na operatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this multicenter, parallel design, prospective,
randomized clinical trial is to compare the clinical safety and economic
outcomes of VAC therapy and SCWT in postsurgical abdominal wound healing
impairments without fascial dehiscence.
Secondary outcome
Secondary endpoints are related to a number of wound healing variables
(re-opened wound, wound size reduction), safety and quality of life.
Background summary
To treat wounds, normally many different types of wound dressings are being
used. It is therefore considered the current standard therapy. Another therapy
used for wound healing is VAC ® Therapy . VAC ® stands for Vacuum Assisted
Closure ®. VAC ® Therapy is a system that uses controlled negative pressure
(vacuum) to promote wound healing.
The KCI VAC ® Therapy * is used worldwide for many years for treating wounds
As healing takes place over a longer period of time from the acute (hospital)
to the post-acute situation (eg home care), this study compares the effects of
KCI VAC ® Therapy * compared to standard wound care (SCWT) during this process.
Study objective
The primary objective of this multicenter, parallel design, prospective,
randomized clinical trial, with repeated observations over time, is to compare
the clinical, safety, and economic outcomes of V.A.C.® Therapy and SCWT based
on an open abdominal wound (also known as: subcutaneous abdominal wounds with
healing impairment) after surgery without fascial dehiscence. The primary
outcome to be observed in this study is time to complete open abdominal wound
closure by Day 42 and confirmed closure after 14 consecutive days.
Study design
Multicenter, randomized controlled, clinical superiority trial
Intervention
Either VAC or conventional wound therpay (through randomization).
Study burden and risks
No additional risks. All risks are general, applicable for all wounds and wound
treatments:
• Pain during debridement
• stinging / burning / pain in wound care dressing
* wound does not close
Ostmerheimer Str. 200
51109 Cologne
DE
Ostmerheimer Str. 200
51109 Cologne
DE
Listed location countries
Age
Inclusion criteria
There are 2 categories of Subjects with distinct post-surgical open abdominal wound diagnoses that will qualify for this study:
• Subjects with primarily closed post-surgical abdominal wounds without fascial dehiscence that develop a spontaneous wound dehiscence or require an active reopening of the wound by the attending physician;• Subjects with open post-surgical abdominal wounds without fascial dehiscence that cannot be closed by primary intention and require further treatment to achieve permanent closure
Exclusion criteria
Pregnant;Dehiscence of the abdominal fascia ;Any pre-existing or ongoing organ system failure;Active signs or symptoms of Abdominal Compartment Syndrome
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36083.068.11 |
| Other | not yet done, after approval |