Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04514783 |
| Other study ID # |
Debridment |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
June 15, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
School of Health Sciences Geneva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic wounds are common and carry out an important and often neglected burden not only to
the individual, the family but also to the society as a whole. The therapeutic approach to
the management of chronic wounds include wound bed preparation or wound dressing management.
Wound bed preparation is a concept emphasizing a holistic and systematic approach to evaluate
and remove barriers to the healing process to allow the wound healing process to progress
normally. Debridement is an integrated part of wound bed preparation, achieving certain goals
and, thus, creating a healthy wound bed, margins and peri-wound skin with the objective to
promote and accelerate healing. Debridement is defined as the removal of foreign material and
necrotic tissue from a wound and it can also help to stimulate wound healing. However, not
all methods of debridement are the same. Each method has advantages and disadvantages that
must be clearly understood. In the present clinical practice, there are several methods of
wound debridement: autolytic, enzymatic, mechanical, surgical (sharp) and biologic. The most
common method is the mechanical debridement. Currently a micro-water jet technique was
introduced into clinical practice. The micro-water jet technique Debritom+ is an effective
alternative to traditional instrument interventions performed with the scalpel and/or
curette. A sterile liquid is expelled from a nozzle at a selected intensity and accurately
sprayed onto the wound surface. The desired effect is the generation of targeted
micro-bleedings to stimulate regeneration and healing processes while preserving the
underlying healthy tissue.
Today, there is no clinical evidence quantitatively comparing one debridement method over the
other. Therefore the invesitgators propose a pilot study to measure the extent of tissue loss
after debridement using Debritom+ micro-water jet technology versus traditional instrument
debridement procedure using scalpel and curette.
Description:
Chronic wounds (CWs) are common and carry out an important and often neglected burden not
only to the individual, the family but also to the society as a whole. A wound becomes
chronic when they fail to progress through a timely sequence of repair resulting in anatomic
and functional integrity within a period of approximatively three months. CWs affect a large
segment of the world population (3) with a prevalence of mixed aetiologies of 2.21 per 1000.
The annual costs of care of patients with CWs is estimated to be £6 billion for 2.2 million
in the United Kingdom (UK).
In CWs a massive production of matrix molecules resulting from underlying cellular
dysfunction and dysregulation can be found. Fibrinogen and fibrin are also common in chronic
wounds and it is thought that these and other macromolecules scavenge growth factors and
other molecules involved in promoting wound repair. Chronic wound fluid is also biochemically
distinct from acute wound fluid; it slows down, and can block the proliferation of cells,
which are essential for the wound healing process. The therapeutic approach to enhance the
wound healing process include wound bed preparation or wound dressing management. Wound bed
preparation as a concept allows the clinician to focus systematically on all of the critical
components of a non-healing wound to identify the cause of the problem, and implement a care
programme so as to achieve a stable wound that has healthy granulation tissue and a well
vascularised wound bed. Debridement is an integrated part of wound bed preparation, achieving
certain goals and, thus, creating a healthy wound bed, margins and peri-wound skin with the
objective to promote and accelerate healing (8). Debridement is defined as the removal of
foreign material and necrotic tissue from a wound and it can also help to stimulate wound
healing (8). However, not all methods of debridement are the same. Each method has advantages
and disadvantages that must be clearly understood.
In the present clinical practice, there are several methods of wound debridement: autolytic,
enzymatic, mechanical, surgical (sharp) and biologic. The most common method is the
mechanical debridement. Autolytic, chemical, and surgical methods are considered to be
selective techniques, whereas mechanical methods are considered to be nonselective. Selective
modalities remove mainly necrotic tissue, whereas nonselective modalities remove both
necrotic and viable tissue. In practice, selective modalities can also remove or damage
healthy tissue. The most selective modalities are autolytic and biologic techniques.
Instrument debridement is the most used debridement method from many years. It has been shown
to improve wound healing and its main advantages are the low cost of treatment and the speed
of dead tissue removal. This method is done with the intention of removing small amounts of
visible devitalized tissue. However, residual nonviable tissue may remain at the microscopic
level resulting in slowing healing process. On the contrary, the risk of exaggerated /
mismanaged excision is not non-existent and can lead to damage to healthy tissue or even
damage to deeper structures (blood vessels, nerves, tendons or even bones), resulting in
delayed healing too. Instrument debridement can be painful. Patient's fear about this
approach is a reality that can also be problematic. Autolytic or enzymatic debridement, which
are more selective and less prone to patient's reluctance could remediate to this situation.
However, time for complete dead tissue removal is considerably increased, requiring multiple
applications and stringent patient compliance. While this type of debridement does not damage
healthy tissue and causes little or no pain, it can cause contact sensitization. Water-jet
debridement systems seems to pose a valid alternative to other methods. The approach is based
on mechanical and homogenous wound cleansing and stimulation by a micro-jet of water. It uses
an ultra-fine, powerful and adjustable micro-jet of water that precisely removes soft to
fibrous deposits from the wound. It is usually fast. Softness of the treatment depends on the
speed and intensity of the water jet according to wound condition. Adequate pain control
should be performed and surface anaesthesia may be required. Water jet debridement promotes
natural wound healing by inducing micro-bleeding from the wound bed and minimizes scarring.
While there is ample anecdotal evidence about the efficacy of such method to preserve healthy
tissue, the investigators propose here to document this ability by measuring precisely wound
depth before and after debridement using Debritom+ micro water jet technology. The
investigators propose to systematically assess patient's apprehension regarding this
technique too.
