Suture TechniquesNCT05781932
Innovative Suture Technique for Endoscopic Hernia Incision
A study testing Dermal barb suture combined with medical glue in people with Suture Techniques and Medical Glue, run by Yizhuo Lu, MD at 1 site in China.
Trial summary
The minimally invasive surgical technique represented by endoscopy is one of the most important inventions in the medical field of the 20th century. Laparoscopic surgery is a technique in which a rod-shaped camera and special surgical instruments are inserted into the body cavity (abdominal cavity, chest cavity, etc.)… Read more about this study
- Who is it for?
- Ages 46 to 82 years
- Conditions the study is for
- Suture Techniques, Medical Glue
- What is being tested?
- Dermal barb suture combined with medical glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) outpatients diagnosed with inguinal hernia by color Doppler ultrasound or CT examination and
- (2) signed informed consent.
Who cannot join
- (1) other serious diseases of the system, such as severe cardiopulmonary dysfunction and liver and kidney insufficiency;
- (2) obvious abnormal coagulation function;
- (3) history of open lower abdominal surgery;
- (4) inability to complete follow-up or treatment compliance;
- (5) high risk of incision infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Barbed Suture Continuous Tension Reduction Suture in Dermal Combined With Epidermal Glue on the Healing of Endoscopic Stuck Hole and Scar Formation
The minimally invasive surgical technique represented by endoscopy is one of the most important inventions in the medical field of the 20th century. Laparoscopic surgery is a technique in which a rod-shaped camera and special surgical instruments are inserted into the body cavity (abdominal cavity, chest cavity, etc.) to complete the surgical operation by poking 3-4 holes (0.5-2 cm in size) in the body wall[2]. These holes are known as poke holes, and the closure of poke holes is a technique that every young surgeon must master. Currently, the proportion of endoscopic minimally invasive surgeries, including inguinal hernia repair, has increased widely in China. Currently, most of inguinal hernia repairs at our center are performed laparoscopically. Shortening the suture time and healing time of the stuck hole, improving the healing strength of the skin, and reducing scar hyperplasia are issues worth discussing.
Barbed sutures were first used in plastic surgery and are now widely used in laparoscopic tissue suturing. Because it is knot-free and one-way tightening, the tension of the incision can be released evenly, avoiding excessive local tension in the incision and causing ischemia and necrosis, which in turn affects the healing of the incision. Barbed thread sutures can be used to quickly close the incision and achieve excellent results. A good incision reduces tension and prevents scarring. Medical glue can quickly form a thin waterproof film on the surface of an incision, which promotes blood coagulation, wound shrinkage, and sealing.
Read more
Inguinal hernia is a common and frequently occurring condition. Minimally invasive surgery for an inguinal hernia can reduce postoperative pain, help patients resume daily activities early, and achieve rapid recovery; therefore, it is being accepted by an increasing number of people[12]. After laparoscopy, the treatment of poking holes is an indispensable part of surgery and is directly related to postoperative recovery, aesthetics, and patient satisfaction. Combining the continuous tension reduction suture of the dermis barbed suture with epidermis glue should help achieve better incision healing, reduce incision scars, and simultaneously return to daily activities faster, shower after surgery, and improve the medical treatment experience. This is the first study to try this novel approach.
A total of 100 patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair in the General Surgery Department of Zhongshan Hospital Affiliated with Xiamen University from January 2022 to May 2022 were selected as the research subjects. They were randomly divided into two groups; the traditional Vicryl interrupted suture was used to poke the hole (control group), and the dermis barbed suture was used for continuous tension reduction suture combined with the epidermis glue to poke the hole (experimental group). Statistical differences were compared between the two stitching methods regarding operation time, incision healing, incision healing scars, and incision complications.
- Conditions
- Suture Techniques, Medical Glue
- Being tested
- Dermal barb suture combined with medical glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal barb suture combined with medical glueProcedure or surgery
In the experimental group, after tension reduction and suture were completed, the wound and surrounding skin were wiped clean with normal saline and clean gauze, and the blood accumulated in the wound was squeezed out. Histoacryl medical tissue glue (specification:0.5 ml/piece, main components: n-butyl 2-cyanoacrylate (embutate), pigment (1-hydroxy-4[(toluene)amino]-9,10-anthraquinone), and stabilizers (p-diphenol, sulfur dioxide, phosphoric acid)) were evenly spread on the surgical incision and kept in the butt state for 4 to 6 seconds. After it got solidify and dry, a sterile gauze covered the surgical incision. There was no need to disinfect and change the dressings after the operation. Patients can shower normally on the day after the operation by just avoiding rubbing the incision covered with glue. Patients can move normally 1-2 days after the operation, and the glue film falls off on its own within 5-10 days.
| Study group | Role | What they receive |
|---|---|---|
| Histoacryl medical tissue glue | Experimental | specification:0.5 ml/piece, main components: n-butyl 2-cyanoacrylate (embutate), pigment (1-hydroxy-4[(toluene)amino]-9,10-anthraquinone), and stabilizers (p-diphenol, sulfur dioxide, phosphoric acid) Receives: Procedure: Dermal barb suture combined with medical glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
During surgery
The time of suturing the punch hole was recorded.
Measured: The time required to close the abdominal wall incision
Surgical incision healing
the wound healing grading standard (grade A healing: the incision healed well without adverse reactions; grade B healing: inflammation, such as redness and swelling at the wound healing site. , induration but not suppuration; Grade C healing: incision suppuration, incision, and drainage are required).
Measured: 2 weeks after the operation,
Scar scoring
Vancouver scar scale (VSS).The VSS mainly evaluates the color, thickness, softness, and vascular distribution of scars, with a total score of 15 points, with higher scores indicating more severe scars.
Measured: Three months after the operation,
Pain score:
According to the corresponding numbers, pain can be divided into different degrees: grade 0, no pain, grade 1-3, mild pain; grade 4- Grade 6 is moderate pain; and grades 7-10, severe pain.
Measured: 1 week after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Mar 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yizhuo Lu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yizhuo Lu, MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781932
- Sponsor's protocol ID
- 2022-261
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Barbed Suture Continuous Tension Reduction Suture in Dermal Combined With Epidermal Glue on the Healing of Endoscopic Stuck Hole and Scar Formation
- ClinicalTrials.gov ID
- NCT05781932
- Acronym / sponsor ID
- 2022-261
- Conditions
- Suture Techniques, Medical Glue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yizhuo Lu, MDUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The minimally invasive surgical technique represented by endoscopy is one of the most important inventions in the medical field of the 20th century. Laparoscopic surgery is a technique in which a rod-shaped camera and special surgical instruments are inserted into the body cavity (abdominal cavity, chest cavity, etc.) to complete the surgical operation by poking 3-4 holes (0.5-2 cm in size) in the body wall[2]. These holes are known as poke holes, and the closure of poke holes is a technique that every young surgeon must master. Currently, the proportion of endoscopic minimally invasive surgeries, including inguinal hernia repair, has increased widely in China. Currently, most of inguinal hernia repairs at our center are performed laparoscopically. Shortening the suture time and healing time of the stuck hole, improving the healing strength of the skin, and reducing scar hyperplasia are issues worth discussing.
Barbed sutures were first used in plastic surgery and are now widely used in laparoscopic tissue suturing. Because it is knot-free and one-way tightening, the tension of the incision can be released evenly, avoiding excessive local tension in the incision and causing ischemia and necrosis, which in turn affects the healing of the incision. Barbed thread sutures can be used to quickly close the incision and achieve excellent results. A good incision reduces tension and prevents scarring. Medical glue can quickly form a thin waterproof film on the surface of an incision, which promotes blood coagulation, wound shrinkage, and sealing.
Inguinal hernia is a common and frequently occurring condition. Minimally invasive surgery for an inguinal hernia can reduce postoperative pain, help patients resume daily activities early, and achieve rapid recovery; therefore, it is being accepted by an increasing number of people[12]. After laparoscopy, the treatment of poking holes is an indispensable part of surgery and is directly related to postoperative recovery, aesthetics, and patient satisfaction. Combining the continuous tension reduction suture of the dermis barbed suture with epidermis glue should help achieve better incision healing, reduce incision scars, and simultaneously return to daily activities faster, shower after surgery, and improve the medical treatment experience. This is the first study to try this novel approach.
A total of 100 patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair in the General Surgery Department of Zhongshan Hospital Affiliated with Xiamen University from January 2022 to May 2022 were selected as the research subjects. They were randomly divided into two groups; the traditional Vicryl interrupted suture was used to poke the hole (control group), and the dermis barbed suture was used for continuous tension reduction suture combined with the epidermis glue to poke the hole (experimental group). Statistical differences were compared between the two stitching methods regarding operation time, incision healing, incision healing scars, and incision complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histoacryl medical tissue glue | Experimental | Procedure: Dermal barb suture combined with medical gluespecification:0.5 ml/piece, main components: n-butyl 2-cyanoacrylate (embutate), pigment (1-hydroxy-4[(toluene)amino]-9,10-anthraquinone), and stabilizers (p-diphenol, sulfur dioxide, phosphoric acid) |
Who may qualify
- Ages
- 46 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1) outpatients diagnosed with inguinal hernia by color Doppler ultrasound or CT examination and
- (2) signed informed consent.
Key exclusion criteria (5 listed)
- (1) other serious diseases of the system, such as severe cardiopulmonary dysfunction and liver and kidney insufficiency;
- (2) obvious abnormal coagulation function;
- (3) history of open lower abdominal surgery;
- (4) inability to complete follow-up or treatment compliance;
- (5) high risk of incision infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermal barb suture combined with medical glueIn the experimental group, after tension reduction and suture were completed, the wound and surrounding skin were wiped clean with normal saline and clean gauze, and the blood accumulated in the wound was squeezed out. Histoacryl medical tissue glue (specification:0.5 ml/piece, main components: n-butyl 2-cyanoacrylate (embutate), pigment (1-hydroxy-4[(toluene)amino]-9,10-anthraquinone), and stabilizers (p-diphenol, sulfur dioxide, phosphoric acid)) were evenly spread on the surgical incision and kept in the butt state for 4 to 6 seconds. After it got solidify and dry, a sterile gauze covered the surgical incision. There was no need to disinfect and change the dressings after the operation. Patients can shower normally on the day after the operation by just avoiding rubbing the incision covered with glue. Patients can move normally 1-2 days after the operation, and the glue film falls off on its own within 5-10 days. | Procedure or surgery | Histoacryl medical tissue glue |
Primary outcome
During surgery
Time frame: The time required to close the abdominal wall incision
The time of suturing the punch hole was recorded.
Surgical incision healing
Time frame: 2 weeks after the operation,
the wound healing grading standard (grade A healing: the incision healed well without adverse reactions; grade B healing: inflammation, such as redness and swelling at the wound healing site. , induration but not suppuration; Grade C healing: incision suppuration, incision, and drainage are required).
Scar scoring
Time frame: Three months after the operation,
Vancouver scar scale (VSS).The VSS mainly evaluates the color, thickness, softness, and vascular distribution of scars, with a total score of 15 points, with higher scores indicating more severe scars.
Pain score:
Time frame: 1 week after the operation
According to the corresponding numbers, pain can be divided into different degrees: grade 0, no pain, grade 1-3, mild pain; grade 4- Grade 6 is moderate pain; and grades 7-10, severe pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermal barb suture combined with medical glue in people with Suture Techniques and Medical Glue, run by Yizhuo Lu, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
During surgery (time frame: The time required to close the abdominal wall incision). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.