The present invention relates to medical devices, uses and methods directed to the treatment of wounds, and more particularly concerns devices, uses and methods for improving wound scarring.
Cuts formed in a person's skin as a result of surgery, trauma, pathological conditions, burns, sports injuries and the like, typically heal in a manner which leaves scarring. While such scarring is often undesirable aesthetically, it can also result in other adverse effects, including loss of function, restriction of movement, reduced skin elasticity, psychological effects due to unsightly appearance and potentially a reduced quality of life.
As such, many attempts have been made to improve scar healing and reduce the adverse aesthetic effects of scarring.
The process of wound healing is known to be occurring in three sequential stages, which may overlap. The three stages are 1) the inflammatory stage, 2) the proliferative or granulation phase and 3) the remodelling phase.
During the inflammatory stage, inflammatory cells are sent to the injury site, and various cytokines, are released, preparing the wound site for the proliferation phase. This stage generally lasts from two to seven days, depending on the wound.
During the proliferative phase, fibroblasts arrive, proliferate and deposit collagen. At the same time, angiogenic factors are sent to the wound environment for stimulating the formation of new capillaries. Keratinocytes are also released across the wound. The proliferative phase is thus characterized by fibroblasts proliferation, as well as collagen production. The proliferative phase generally lasts from four days to several weeks, depending on the wound. Hypertrophic scars and keloids generally form during this phase.
During the remodeling phase, collagen forms and degrades and myofibroblasts contribute to increasing the tensile strength of the skin surrounding the wound. Granulation tissue deposition decreases as the cells responsible during this stage are suppressed; failure for this to occur often results in a hypertrophic scar. In the case of a hypertrophic scar, an overzealous healing response occurs, in which fibroblasts, small vessels, and collagen fibers are arranged in a nodular pattern. Alternatively, collagen can be inadequately replaced and, as a result, can form a pitted, unaesthetic appearance. The remodeling phase occurs at the end of the wound healing process, up to several weeks after the wound occurred.
Various pharmaceutical creams, powders, beads and other medicaments exist which, when applied to the wound site, are intended to reduce the effects of scarring by interfering with the proteins known to be involved in wound healing, skin growth and scar formation. The biological mechanisms involved in wound healing and scar formation are complex, and involve the interaction of many proteins in a series of steps. One particular protein (cytokine), TGF-β1, has been identified as playing a major role in scar formation. Particularly, reduced blood flow to the wound site causes hypoxia, which stimulates the deposition of extra-cellular matrix in response to the injury. The molecular signals that induce the localized production of such an extra-cellular matrix are regulated by TGF-β1. Therefore, the inhibition of TGF-β1 dependent pathways may prevent the profibrotic effects involved in scar formation.
Attempts have therefore been made to manipulate the mechanical regulators which regulate TGF-β1, such as tissue stretch or massage for example, as therapy for improved healing of large scars or diseases of excessive scarring, such as keloids for example. Several articles and studies discuss this matter, for example “Tissue Stretch Decreases Soluble TGF-b1 and Type-1 Procollagen in Mouse Subcutaneous Connective Tissue: Evidence from Ex Vivo and In Vivo Models” by Bouffard et al., from the University Of Vermont College Of Medicine. U.S. Pat. No. 6,756,518 B2, issued Jun. 29, 2004 to Gruskin et al., for example, discloses a method of reducing scar formation at a wound site by applying a TGF-β reducing amount of a cross-linked polysaccharide having a positive charge.
Many other more approaches have also been attempted to reduce localized scar formation at a wound site. For example, stitches, frames, adhesives, and other such devices which prevent relative motion of the skin around the area of the cut have been employed. Other devices are also known which draw the skin on opposing sides of a cut together, which maintain bandages in contact with a wounded area, or which attempt to immobilize skin the region of a cut in an attempt to reduce scarring as the cut heals. For example, U.S. Pat. No. 5,693,068, which issued Dec. 2, 1997 to Kuhlman, describes a scar-reducing frame structure which surrounds the cut and is removably attached to the skin such as to prevent motion relative to the healing cut, thereby allowing the cut to heal without being partially or fully reopened, which is said to damage the portions of the skin at the cut that had begun to heal. U.S. Pat. No. 8,183,428 issued May 22, 2012 to Gurtner, proposes a method of treating wound scarring by adhering an elastomeric material which compresses surrounding skin surface toward the wound, so as to reduce stress at the wound site.
Despite the attempts made to date to provide a device and/or method for facilitating healing of a skin wound such as to reduce scarring, there exists a continuing need for improvement in this respect.
According to an embodiment of the invention, a scar reducing device for stretching skin having a closed wound is provided, so as to reduce scar formation. The device includes first and second fasteners removably attachable to skin regions located proximate to the wound, and an extension mechanism. The extension mechanism is movable between contracted and extended configurations. When the fasteners are affixed to the skin regions, the extension mechanism forces the first and second fasteners away from one another with a predetermined tensile force, thereby stretching the skin proximate to the wound.
According to an embodiment of the invention, there is provided a scar reducing device in which the extension mechanism includes first and second members aligned longitudinally with one another. Each of the members has inner and outer ends. The extension mechanism also includes a biasing element disposed between the inner ends of the members, the biasing element being able to generate a predetermined tensile force and allowing for the displacement of the first and second elongated members along a longitudinal axis, thereby moving the extension mechanism from a contracted configuration to an extended configuration. The first and second fasteners are removably attachable to skin regions located proximate to the wound.
Each of the fasteners includes a first connecting portion for attachment to the skin, and a second connecting portion affixed to the outer end of a corresponding member, the first and second connecting portions being manually attachable and detachable from one another.
When in use, the fasteners are affixed to the skin regions such that the longitudinal axis of the extension mechanism is substantially parallel to the wound, the biasing element forcing the first and second fasteners away from one another with the predetermined tensile force, thereby stretching the skin proximate to the wound.
According to another embodiment of the invention, use of the scar reducing device is made, for reducing scarring of a closed wound. Preferably, use is made for periodic and limited time intervals.
According to another embodiment of the invention, a method of reducing scarring of skin having a closed wound is provided, the wound having a segment with a substantially linear direction. The method comprises a step of periodically stretching the skin proximate the wound in a stretching direction which is substantially parallel the linear direction of the segment, with a predetermined tensile force.
According to another embodiment of the invention, the method comprising the steps of:
According to another embodiment of the invention, the method comprises the steps of:
Other objects and advantages of the invention will become apparent upon reading the detailed description and upon referring to the drawings in which:
Scars formed in skin as a result of a healed wound, such as a wound formed due to surgery, trauma, pathological conditions or burns for example, are undesirable for a number of reasons, not the least of which are the adverse aesthetic effects that such scarring causes. The scar reducing device, according to an embodiment of the invention, is therefore provided to decrease the formation of scarring at such a wound site, thereby improving the aesthetic appearance of the wound, once fully healed. The term “wound” as used herein is intended to include any cut, rip, or other opening in the skin which may be caused by the aforementioned reasons.
The scar reducing device described therein differs significantly from previous attempts to achieve reduced scar tissue formation, and in fact functions in a manner fully contrary to what is currently proposed by existing devices currently available for wound scarring treatment. Current devices are designed such as to draw the skin on opposing sides of a wound together. Other devices work so as to immobilize the skin in the wound region.
As will be appreciated, the scar reducing device described below generates a shear, or stretching, force in the wound and/or surrounding skin which, when applied periodically during the proliferative phase of wound healing, that is, after the wound has closed but before scar formation has completed, reduces formation of scar tissue and therefore reduces the overall scarring left behind once the wound has fully healed. As such, the present device is intended for post-operative use on closed wounds to reduce scar formation.
The present devices works and is applied in a manner which is completely opposite to what other existing devices are promoting. An example of such an existing device is the Embrace™ Advanced Scar Therapy from Neodyne Biosciences™, which creates a stress shield around the wound, so as to avoid as much as possible any stress to be applied or transferred to the wound.
In contrast, the scar reducing device described therein allows for the application of tensile stress, periodically, that is, over several days, during limited time intervals, and with a predetermined tensile force, in the skin tissues of the wound and surrounding the wound. Indeed, it was found that applying stress to a closed wound, for periodic and predetermined time intervals, with a predetermined tensile force, leads to a reduction of the concentration of the TGF-β1 protein near the wound, which will in turn reduces collagen and fibroblast concentrations, resulting is a smaller scar of improved appearance.
In the following description, the same numerical references refer to similar elements. Furthermore, for the sake of simplicity and clarity, namely so as to not unduly burden the figures with several references numbers, not all figures contain references to all the components and features of the present invention and references to some components and features may be found in only one figure, and components and features of the present invention illustrated in other figures can be easily inferred therefrom. The embodiments, geometrical configurations, materials mentioned and/or dimensions shown in the figures are preferred, for exemplification purposes only.
Referring to
As best shown in
Referring to
Referring to
Still Referring to
In this particular embodiment, the two members 38, 40 are made of Teflon™. Of course, other material can be considered, such as metal or polymeric material. The tubular central body 41 preferably includes plastic tubing made from transparent material. Preferably, although not necessarily, the tubular body 41 is allowed to bend slightly (i.e. away from the surface of the skin) when the members 38, 40 are outwardly biased into their extended position.
Referring to
Referring to
The first connecting portion 34b is devised to be left on the skin 12 for several days during which the treatment will last, and preferably without removal during this period. The first connecting portions 34a, 36a can also be referred to as skin engaging fasteners. The first connecting portion 34b can be fastened to the skin using different types of connectors 35b. In
Still referring to
The adhesive force of the first connecting portions 34b must be able to resist a shear force relative to the skin that is greater than the predetermined tensile force generated by the biasing element. In other words, the connector which anchors the skin engaging fasteners to the skin must be stronger that the tensile force generated by the biasing member, otherwise the extension mechanism will over power the anchoring force of the skin engaging fasteners, causing detachment of the extension mechanism from becoming detached from the skin. The same reasoning applies to the detachable connection between the first portion 34b and the second portions 36b of the fastener 18. Once connected, the detachable first and second portions must be stronger than the tensile force applied by the extension mechanism.
Turning back to
The biasing element 26 may be detachably fixed to the inner ends 42a, 42b of the first and second members 38, 40 such that the biasing element 26 is replaceable. This may be desirable, for example, if the biasing element 26 is to be removed and replaced with another having a different spring constant, that is stiffer or softer, as required. This allows selection of the biasing element 26 so the extension mechanism 24 may generate adequate predetermined tensile force. This may also be advantageous if the biasing element 26 is to be maintained in the device 10, but the two members 38, 40 are to be replaced, as may be desirable if the device is to be used several times, with one or more different patients.
In the alternate embodiment wherein the biasing element 26 is magnetically driven, permanent magnets for a selected magnetic force and having opposed poles are fixed to each of the inner ends 42a, 42b of the members 38, 40, such that they repel each other thereby forcing the members 38, 40 longitudinally outwardly within the tubular body 41. Alternately, electro-magnets can be used which are controlled such as to repel each other for a predetermined amount as required to create a selected overall length of the device.
Yet other types of resilient elements can be considered, such as an endless screw or a rack-and-pinion mechanism. In such cases, it is required to first attach the extension mechanism 24 to the skin engaging fasteners first, while the mechanism is in the contracted configuration, and then once attached, to move the mechanism 24 from a contracted to an extended configuration, so as to stretch the skin tissues, for example with a screw, so as to control the level of force, or stretch, applied to the skin.
Preferably, the biasing element 26 generates equal and opposed longitudinally acting force on the members 38, 40 which have the effect of forcing an expansion of the scar reducing device 10.
The biasing element 26 thereby, when the opposed outer ends 44a, 44b of the members 38, 40 are fastened to the skin 12 as described further below, generates a substantially constant shear force in the skin 12 surrounding the closed wound 14, and thus in the wound 14 itself. When such a static shear force is imposed on the skin 12 it stretches, reducing the concentration of TGF-B1 thus suppressing the activity of collagen-producing cells occurs in the healing wound. As such, scar formation can be decreased. This stretch or shear force applied to the wound 14 by the present scar reducing device 10 is preferably applied during the proliferative phase of wound healing, which begins after the wound has closed but before the scar has completed formation the proliferation phase, which follows immediately the inflammation phase, may begin from 5 to 21 days after the initial wound formation, and can vary from one patient to another and from one wound to another. It is of note that the terms “shear force” and “shear stretch” are used herein interchangeably, and are intended to comprise any stretching of the skin produced by a force applied in a plane substantially parallel to the skin surface.
The biasing element 26 may be free to axially move relative to the surrounding central body 41, whereby the entire sub-assembly formed by the two members 38, 40 and the linking biasing element 26 disposed there in-between is longitudinally displaceable within the tubular central body 41. Alternately, however, the biasing element 26 may be located in position at a central point within the tubular central body 41.
Additionally, although the first and second members 38, 40 and the tubular body 41 are depicted in the figures as having a circular cross-sectional shape, it is to be understood that in alternate possible embodiments, one or all of these components may have any one of a rectangular, circular, square, trapezoid, toroid, oval cross-sectional shape. The first and second members 38, 40 may also be composed of several, linked-together, portions rather than being formed from a single integral rod as depicted.
Preferably, the biasing element is able to generate a predetermined tensile force between 100 and 2000 g. Still preferably, this interval is between 250 g and 1200 g, and more preferably, between 400 and 800 g. The device 10 may also preferably includes a controlling mechanism 146, allowing to controllably varying the tensile force of the biasing element.
Still preferably, the device 10 includes a sensor 50 for measuring one or several biometric characteristic(s) of the skin in the region of the wound, such as temperature, humidity, and tensile strength of the skin. The sensor 50 can also measure static shear stretch generated by the extension mechanism in the skin tissues. Still preferably, the sensor can measure a concentration of collagen at the skin surface or within the skin. The sensor may also include the indicator in communication therewith, which is operable to indicate at least a level, if not an exact value, of the measured characteristic, such as a general level of the static shear stretch applied to the wound for example.
In a preferred embodiment, the sensor 50 also includes a wireless signal generator operable to send readings from the sensor to a remote receiver (connected to a server and/or computer, for example) for data collection and storage. This permits either the patient or physician the ability to monitor the progress as the wound heals, in order to be able to better track the formation of scar tissue. Additionally, the force produced by the device 10 can be adjusted by the patient or physician based on the information received from the sensor 50. Usage of the device 10 can thus be modified as required, for example used for longer periods or at a higher frequency, if deemed necessary in order to reduce the scar formation to a desirable level. As skin characteristics tend to vary between individuals (ex: different skin thicknesses, tensile strengths, etc.), the ability to monitor wound healing and adjust the amount of shear force applied to the wound/skin by the present device is advantageous. With such preferred embodiment, the device 10 is not only able to deliver stretch to the wound site, without requiring the patient to apply any external force to the device during use, but also to adjust it according to the patient's specific skin profile.
Alternatively, or in combination with the controlling mechanism, the device 10 includes an indicator 48, indicative of the tensile force of the biasing element. As shown in
Referring now to
The scar reducing device 110 is used in the same manner as the device 10 described above. The device 110 is compressed in the contracted configuration until the desired predetermined tensile force is accumulated in the biasing element 126. A controlling mechanism 146 allows controlling the force accumulating in the biasing element. For example, the controlling mechanism can comprise a serrated groove extending along the member 140, and a releasably engaging pin cooperating with the serrated groove, for allowing control of the level of compression of the extension mechanism. An indicator 148 can also be placed on the outer surface one of the members 138, 140, so as to provide an indication of the compression of the biasing element. In use, the fasteners are fastened to the skin on opposite sides of the wound during a proliferative phase of the healing thereof, such that the static shear stretch generated in the wound and/or skin reduces scar tissue formation in the wound.
Referring now to
In
The length L0 by which the fasteners 216 and 218 are spaced apart, the length L1 of the flexible rod 224 and its resiliency are selected so that the force exerted by the rod 224 when disposed between the fasteners 216, 218 corresponds to a predetermined tensile force. In other words, the resiliency of the biasing element 224, which is characterized by an elasticity constant or elastic coefficient, and its length L1, is selected so than when compressed to L3, it exerts the predetermined tensile force. Of course, the predetermined tensile force can be a range, or interval, of force.
Referring now to
Referring to
All of the embodiments described above may be fully disposable, such that it is intended to be used on a single-use basis by a patient who installs the device himself or herself during the healing process of a skin wound. Accordingly, the materials chosen for the device may be selected in consequence.
Of course, any of the embodiments described above can form a kit, which includes the different components such as the extension mechanism and/or fasteners. Preferably, a graduated ruler can be included in the kit for facilitating positioning of the fasteners on the skin, and ensuring that they are spaced apart by a predetermined length L0.
The scar reducing device as described herein may therefore be used in the following manner, in accordance with the described method for facilitating the healing of a skin wound such as to reduce scarring.
The method is devised to be performed on a closed wound, which has at least one a segment with a substantially linear direction. By closed wound, it is meant a wound which as at least one segment closed, the segment being able to resist tensile forces of less than 250 g without opening. By substantially linear, it is meant a generally linear orientation. The wound can comprise only one segment, which is substantially linear or it can comprises several segments, where if the general aspect of the wound is not linear, at least one or some segments have a general linear profile.
According to one aspect, the method includes a step of periodically stretching the skin proximate the wound. By periodically, it is meant that the stretching is repeated several times during a given period. The given period preferably begins toward the beginning of the proliferative phase of the wound scarring and ends prior the end of the remodeling period. Still preferably, the treatment begins towards the end of the proliferative phase of the wound, and ends toward the beginner of the remodelling phase.
The treatment period can begin about 5 days after the date of injury date and last until about 45 days after the date of injury. Alternatively, the period begins from 10 to 15 days after the date of injury, and end from 20 to 40 days after the date of injury. Of course, the period can vary according to the severity of the wound, the skin type of the patient, the length of the wound, and the likes.
The stretching is made in a stretching direction which is substantially parallel to the linear direction of the wound or wound segment. For example, the angle formed between the stretching direction and the wound segment direction can vary between 0 and 45 degrees.
The stretching of the skin is made with a predetermined tensile force. The tensile force can vary between 100 g to 2000 g, and is preferably between 250 g and 1200 g, and still preferably between 400 and 800 g. As it will be explained in the Example provided thereafter, a tensile force which is too small or too great will not lead to reducing of the scar. In cases where the tensile force applied is too great, that is, outside the predetermined ranges described above, scarring of the wound is likely to be increased, rather the decreased, as desired.
During the treatment period, the stretching is performed for predetermined time intervals. A time interval is relatively short, and preferably varies from about 5 to about 20 minutes. Still preferably the time interval is between 8 and 15 minutes. Preferably, the stretching step is made twice a day. The stretching step is preferably performed about every 12 hours. It can also be considered to perform the stretching step only once a day, and up to four times a day.
Referring now to
Or course, in an embodiment of the method in which an endless screw, or a rack and pinion system is used as the scar reducing device, the step 630 of configuring the extension mechanism consists of first attaching the extension mechanism to first and second fasteners, and then extending the mechanism to its extended configuration, once affixed to the skin.
Referring now to
It is to be understood that the force generated by the biasing element of the scar reducing device is selected to be insufficient to open a healing wound, even if the device is applied to the wound as described above too soon, that is before the proliferative phase of wound healing (roughly 21 days after the initial wound creation).
Although the specific duration and frequency of use of the scar reducing device can be varied and determined as required by the directing physician, in at least one possible usage contemplated, the device is preferably applied to the wound for periods of only 15 minutes, two times per day.
The device described herein may be disposable, and thus may only need to be used once or at least a limited number of times before being discarded. For purposes of reducing possible infection of the wound, such a one-time use of the device may also be desired. However, the device 10 may also be configured for multiple re-uses. As such, in at least one embodiment, all parts of the scar reducing device may be composed as to allow for sterilization such as gamma irradiable or vapour sterilization, heat sterilization.
Studies have shown that tension at the site of the wound can worsen scar formation, such as described by Huang C, Akaishi S, Ogawa R. in the article entitled “Mechanosignaling pathways in cutaneous scarring” (Archives of dermatological research. 2012. Epub 2012 Aug. 14). A demonstration that stress can induce or promote hypertrophic scar formation is also made in U.S. Pat. No. 8,183,428 to Gurtner. However, recent studies suggest that mechanical forces acting on a scar can be a factor in scar formation and may decrease scar formation. Bouffard et al. describe a series of investigations in article entitled “Tissue stretch decreases soluble TGF-beta1 and type-1 procollagen in mouse subcutaneous connective tissue: evidence from ex vivo and in vivo models. Journal of cellular physiology. 2008; 214(2):389-95. Epub 2007 Jul. 27.” Massage and mechanical manipulation have also been often recommended to patients for treatment of scars.
The study presented below was conducted based on the hypothesis that tissue stretch parallel to a scar may decrease scar formation. To investigate this we set out to create a device and animal model in which to investigate the effects of longitudinal tissue stretch on scar formation.
A scar stretch device was designed that can easily attach and detach from skin. The components of the device included a skin adhesive mechanism and an extension force mechanism. The device prototypes were constructed using inert materials: Steel spring, polyvinyl tubing, Teflon rods, and an adhesive. Three different spring strengths for the scar stretch devices were created and labeled as 0.5×, 1× and 2× to investigate a dose response. The devices were standardized to ensure similar extension force using a small force gauge from Jonard Industries.
The experimental protocols used in these experiments were approved the McGill University Ethics and review board. All mice were female Balb/C weighing 19-21 g. Thirty mice were divided equally into 6 groups, as per
Group 1 included control mice without scar. Group 2 mice received a dorsal incision and no treatment. Group 3 mice received a dorsal incision and treatment with a sham device. Group 4 mice received a dorsal incision and treatment with a stretch device that was half strength (0.5× group). Group 5 mice received a dorsal incision and treatment with a stretch device that was full strength (1× group). Group 6 mice received a dorsal incision and treatment with a stretch device that was double strength (2× group).
It is also worth mentioning that correlations can be established between mice data and human data, for example as described in “A Review of the Role of Mechanical Forces in Cutaneous Wound Healing” from Riaz Agha et al. (Journal of Surgical Research 171, 700-708 (2011)).
Under isoflurane anesthesia, 24 mice were shaved and received a three centimeter incision in the middle of the back at the level of the scapula. A microsurgery blade was then used to cut the subcutaneous tissue attachments between the pannicular muscle and the back muscles (0.5 cm of undermining lateral to the incision bilaterally). Incisions were closed primarily with Steri-strips™. One mouse in the control scar group (group 2) was eliminated due to wound dehiscence.
On day five post-incision mice underwent stretching of the trunk for 10 minutes, twice a day, for 10 days. All mice underwent anesthesia with isoflurane and mice in groups 3 to 6 underwent stretch treatment with device. The device was aligned in parallel over the scar and attached only during the 10 minute stretch period. After 5 days after the last stretch treatment, ie (20 days post-incision, all mice were euthanized. The skin of the back was excised and fixed for 2 h in 3% paraformaldehyde in phosphate buffered saline (PBS). Skin samples were also frozen and stored for biochemical analysis.
Photos of scars 15 days after beginning tissue stretch, ie 20 days post incision, were qualitatively analyzed using the Vancouver Scar Scale.
Following fixation, cutaneous tissue samples of 1 cm×1 cm and 30-50 μm thickness, centered 1 cm lateral to the spine at the level of the surgical incision, were taken and mounted on glass slides. Slides were stained with Masson-Trichrome to show collagen and described using light microscopy.
Thawed skin samples were homogenized and immediately assayed for (1) TGF-β1 protein using a human TGF-β1 ELISA assay (R&D Systems, Minneapolis, Minn.) including sample acidification with 1N hydrochloric acid for activation of latent TGF-β1.
Analyses of variance (ANOVA) were performed to test for differences of TGF-β1 level between treatment groups. ANOVA was used to analyze the effects of stretch on TGF-β1 concentrations after five days after 10 consecutive days of stretch therapy. For these analyses, TGF-β1 data were log transformed prior to analysis in order to satisfy the normality and homogeneity of variance assumptions associated with the ANOVA. Statistical analyses were performed using SAS statistical software (PROC MIXED). P values <0.05 were considered statistically significant.
A total of 20 devices were created and grouped into four different stretch strengths categories. The force produced of by each device, except the sham was measured.
Photos of scars 15 days after beginning tissue stretch, ie 20 days post incision were qualitatively analyzed using the Vancouver Scar Scale, as shown in
Paraffin embedded sections were stained with Masson's Trichrome in order to better visualize collagen deposition. Sham, control scar and 2× groups showed greater collagen deposition and a thicker dermal scar than the 0.5× and 1× treatment groups
TGF-β1 protein levels in cutaneous scar 20 days after incision were significantly higher in the control scar (471.9±13.8), sham (383.3±49.2) and 2× stretch (401.3±41.1) treatment group. TGF-β1 levels were significantly lower in the stretch treatment groups 0.5× (342.±9 and 1×254.±3, as illustrated in the graph of
It is worth mentioning that preliminary tests were also conducted on human skin, with satisfactory results. The device was used for a period of 9 days on a closed wound, with a tensile force between 400 g and 800 g.
In summary, the present study confirmed that using a scar reducing device as described above allows reducing scarring of wounds. The study also allowed confirming efficiency of using such device, and of the method for reducing scarring. The study allowed determining the period, timing interval and range of tensile force that need to be applied to a closed wound for obtaining reduced scarring of wound.
Although preferred embodiments of the present invention have been described in detail herein and illustrated in the accompanying drawings, it is to be understood that the invention is not limited to these precise embodiments and that various changes and modifications may be effected therein without departing from the present invention.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/CA2012/050816 | 11/16/2012 | WO | 00 | 5/15/2014 |
Number | Date | Country | |
---|---|---|---|
61560322 | Nov 2011 | US |