Chapter 10 Clinical Trials
Throughout September, Chen Changan was busy with biological and mass testing of collagen sutures on fish skin.
He instructed Guan Kou to buy some of the most mainstream artificial chemical sutures on the market and Ranyuan's collagen sutures and make three different control groups with the home-produced fish skin collagen sutures.
Large wound sutures and small wound debride sutures were performed on the three rabbits. The suture effects, absorption effects, and the proportion of wire tension loss at different absorption stages were compared.
Judging from the final results, the fish skin sutures are perfectly better in terms of wound healing speed, the anti-tension weakening value, and the beauty of the wound.
Especially in terms of tension, the tensile strength of the artificial chemical suture incision is not as strong as that of the fish skin collagen suture, let alone pure collagen suture.
Under the biological clinical manifestations of fish skin collagen suture, it can retain 70% tensile strength 30 days after surgery, and can maintain 55% tensile strength 50 days after surgery.
In addition, the tensile strength of the fish skin collagen suture was better than that of the other two control groups, so the experimenter boldly speculated that the fish skin collagen suture could even be used for tendon sutures and muscle sutures that the other two absorbable sutures cannot be used!
Fish skin collagen sutures once again have a core competitiveness that is stronger than other products!
In addition, none of the ten groups of rabbits who used fish skin collagen sutures did not have any inflammatory reactions or bacterial infections. The safety is very good, and the healing time is much faster than that of artificial chemical sutures, which is similar to the healing time of pure collagen sutures.
This shows that fish skin collagen sutures can also promote wound healing!
After receiving this precious test report, Chen Changan immediately arranged for Guan Kou to lead employees of the company's administrative department to go to the Drug Administration to apply for clinical trials!
in the country, medical devices are divided into three categories, one, two and three categories.
The simplest category is, such as the suture needles, non-absorbable sutures, medical masks and other ordinary low-end consumables produced by companies in the past, basically belong to the first category of medical devices. As long as the company meets the production qualifications required by the relevant departments, it can obtain a production license and an industrial and commercial license for production and sale.
However, the second and third categories are different. As long as any medical product involving implantation into the human body, you need to apply for clinical trials first, and then the reliability and safety of the product are proved through strict clinical trials before the filing is completed, and then you apply for a production license and business sales license.
Fortunately, Chen Changan prepared enough test data, and there are comparison data from the control group. The company has all the qualifications, various licenses and sales certificates, and also has medical professionals or related professionals required by relevant departments.
In addition, the Chen family also has some connections, so it took Guan Kou less than ten days to get a clinical trial license for the collagen suture of fish skin.
After all, this is a breakthrough technology in medical care and has complete experimental data support. When the Drug Administration confirmed that the test data was not falsified, it naturally gave the green light.
Even in the paper or online reports of many official media, there have been news reports about Ruikang Medical's breakthrough in suture technology.
"The new generation of absorbable sutures have been approved for clinical trials, and the technology is very advanced!"
"Fish skin collagen suture may replace existing artificial chemical sutures and become the next mainstream medical suture!"
Of course, these few news reports did not cause any trouble, because ordinary people would not pay attention to any medical information, and they would only search for some specific cases online after they became ill.
However, many domestic medical practitioners have paid attention to this information, especially some pharmaceutical agents and dealers, who called one after another.
The company's sales department and customer service department replied in a unified manner: "Everything is still under test, please wait patiently for the test results."
Chen Changan didn't dare to blow the cowhide out now. Although he was sure that the fish skin collagen suture technology he produced was very mature, he should not speak nonsense before obtaining a production license and sales license, and he would not be able to do anything randomly, and something would happen.
.............
On October 7, a day with a squeaking autumn wind, during the National Day, the emergency building of the First Hospital of Gusu City was very busy.
Perhaps because of the National Day holiday tourist season, various trauma emergency departments of Gusu First Hospital have been coming one after another in the past few days. All interns, regular medical training, resident doctors, and even attending physicians are busy.
But at this moment of busyness, the president, vice president, director of the First Hospital of Gusu City, director of the medical department, director of the supply department, director of the emergency department, and other bigwigs were waiting outside the emergency building in white coats.
I don’t know what happened to this situation, but I thought that some great man had an accident, and even alarmed the leaders of the First Hospital of Gusu City waiting for ambulances here.
"Here you come." Director Chen, the youngest and best-looking medical department, was the first to see an Audi A4l heading into the hospital gate, followed by an ordinary car and a transport vehicle.
In less than two minutes, the Audi A4l stopped in the aisle outside the emergency building. The driver opened the door and walked down from the main driver's seat. The attentive sports car opened the rear door.
As soon as the back seat was stretched out with a long legs in suit pants, the president of Gusu First Hospital took the lead in welcome and said: "Welcome to our hospital to carry out clinical trial projects!"
Chen Changan, who got out of the car, greeted him with a smile, grabbed the dean's hand and said, "As a local from Gusu City, I am a famous name from the First Hospital of the City for a long time. The medical level of the First Hospital is very high. I have seen the disease several times and it has been cured very quickly!"
As a top-level regional tertiary hospital, Gusu First Hospital has an influence that spreads to the entire Jiangnan Province, and its medical level is indeed very strong.
The dean also smiled and held Chen Changan's hand and said politely: "Where is there, the level of our hospital is still very insufficient. My surname is Lin, and I am currently the director of the First Hospital of Gusu City."
"Hello Dean Lin."
After a while of affectionateness, the two walked side by side into the emergency building, and the atmosphere was very harmonious.
Generally, pharmaceutical companies and medical device companies are inferior to those in front of Grade A hospitals, because there are many large comprehensive Grade A hospitals that can choose from. For them, which company product is like the emperor choosing a concubine, it all depends on their mood.
Especially for pharmaceutical consumables, except for imported ones, the performance of each domestic consumables is basically the same, and there is almost no difference when used on patients.
Therefore, the choice of products for which company is entirely in the hands of hospitals and doctors. A large comprehensive hospital may have hundreds of medical agents mingling every day, asking doctors and nurses about their well-being and helping them.
In theory, if the boss of a small medical device production company in Chen Changan comes to the hospital with something, there is no need for the dean, the vice president and a group of leaders to come out to entertain him.
But Chen Changan came to the First Hospital of Gusu this time with a clinical trial project with a fish skin collagen suture.
After learning about the specific efficacy and adaptability of the fish skin collagen suture and the wide audience, Director Lin immediately classified this clinical trial as the most important project of the First Hospital of Gusu City!
This technique is a scorpion poop, and it’s unique!
If the clinical trial can be passed smoothly and can prove that all the parameters of this suture are real and effective, and are very safe and reliable, then this suture will directly change the suture history of the entire medical community and eliminate all other sutures!
Then Ruikang Medical will be amazing. At that time, there will be such a company in the country that can produce such sutures, and the status of the hospital and Ruikang Company will be completely changed.
If Ruikang becomes the emperor, major hospitals become concubines. Ruikang will sell it to any hospital that Ruikang wants to sell it to. After all, Ruikang's productivity will definitely not meet the needs of hospitals across the country in a short period of time, and I am afraid that even Jiangnan Province will not be able to meet it!
Therefore, now the First Hospital of Gusu City must entertain the owners of Ruikang Company so that after the finished product is produced, the First Hospital of Gusu City can receive the first batch of goods.
This is also very beneficial for the hospital to further increase its reputation.
At that time, other hospitals will use ordinary absorbable sutures, while Gusu First Hospital uses absorbable sutures that are more than one generation of technologies. Doesn’t this mean that the medical level of Gusu First Hospital is stronger than other hospitals?
Chapter completed!