Background

The advent of elective surgery has promoted more efficient repairs of surgical wounds. In the eyes of the patient, the scar remains the only visible evidence of the surgeon skill, and all their efforts are often judged by the final appearance of the skin.
Any open surgical procedure requires an incision based on anatomical principles and a wound closure that result in a resistant, safe and aesthetic scar.

A well-planned incision has four essential elements:

• Accessibility
• Extensibility
• Preservation of function
• Security


Surgical wound complications are important causes of early and late postoperative morbidity. Mechanical failure or failure of wound healing at the surgical site can lead to disruption of the closure leading to seroma, hematoma, wound dehiscence or hernia. Other complications include surgical site infection and injury caused by poor technique.

The current scenario of unresolved complications raises the need for a new generation of techniques for incision and wound closure, capable of meeting the following functional requirements that have not yet been met by the available technology:

i. Minimally invasive performance
ii. Reduction of Infection risk
iii. Prevention of hypertrophic scarring


Mission:

To consolidate a competitive company in the medical device sector, focused on the development, production and marketing of devices for incision and closure of the skin.

Vision:

To be leaders in the commercialization of a family of medical products that give satisfactory and concrete answers to the current demands for the prevention and management of pathologies related to surgical wounds.





Advantages

INCLODE would reduce the time required for the closure of surgical wounds along with the number of postoperative medical visits. It would also reduce the costs derived from the complications of the surgical site.
Its standardized accuracy for wound closure would allow much more satisfactory cosmetic results than those offered by current artisanal techniques.



The product

INCLODE is a surgical device intended for the realization and repair of an operative cutaneous access. It has application in the superficial incision and closure of the skin, both in open and minimally invasive surgeries.



Use Case

1 - Placement

Before beginning the surgery, the septum is placed between the strips, occupying the incision groove and the slit of the tape. The septum serves for keeping the strips separated at a precise distance until the device adheres to the skin.

2 - Preparation for the incision

Once the device is firmly attached to the skin, the longitudinal septum is removed and the exposed skin surface is inspected at the bottom of the incision slot, where the cut will be made.

3 - Incision

To perform the incision, the surgeon uses the central groove as a cutting guide. Both the incision and the rest of the intra-operative procedures are carried out according to the conventional technique chosen by the operator, including the hemostatic technique by electrocoagulation and the suture of deep planes.

4 - Closure

After completing the main procedure and repairing all the subcutaneous planes, the device will be used to close the skin. The teeth of the removable closure are inserted into the lateral ducts of each strip, and compressed until the correct anchoring of the complementary teeth is achieved throughout the entire device.

5 - Healing

The device will remain attached to the skin for the same indicated time to maintain a conventional suture. After that period, the tape will be removed following its longitudinal direction and the device will be discarded as a pathogenic waste.

Our History

During his time at the medical school, every time that Pablo Luchetti witnessed a surgery, he was surprised that the closure of the skin still depended on such an artisanal and invasive technique as the suture.

Tensile strength and precision are the two fundamental pillars for the closure of a wound. Suture techniques meet these demands, but at the expense of additional injury and a complex training of the surgeon.

An alternative technique of minimal invasiveness and easy learning was needed.
The first challenge was to deconcentrate the tensile strength from the edges of the wound and transfer it to the surface of the surrounding skin.

The second big challenge was to obtain a mold of the intact skin, before cutting. This copy should be stored in the elastic memory of the device and then be accurately reproduced at the time of closure.
This is how the concept of Inclode arose: a self-adhesive patch with a closure mechanism fitted onto it.

The next great challenge was to find proper materials and design capable of copying and reproducing the intact skin.
From that moment, Luciano Poggi joined the project to handle the technical decisions of the product and Diego Fridman was associated to communicate scientific evidence and establish partnerships with external health professionals.


The Team

Diego Hernán Fridman MD, MSc.

Medical Doctor with experience in clinical and epidemiological research. Director of Clinical Research Department at Centro de Estudios Infectológicos (FUNCEI) en Argentina. Chairman of the Ethics Committee in Clinical Research (CEIC). Professor in charge of Geology in the Faculty of Exact and Natural Sciences of the University of Buenos Aires. Chairman of the Executive Committee of the International Medical Geology Association (IMGA). Co-founder and Medical Director of INCLODE.

Awards

The project won the first prize in the edition of the Israel Innovation Awards 2018. This recognition will allow promoting a technological cooperation between the INCLODE project and entrepreneurs from different countries, through initiatives oriented to the international market, launched from the ecosystem of Israel's technological innovation.




News and Interviews

After obtaining the Israel Innovation Awards Prize in October 2018, the project has been broadcasted through various media:



LINKS