Wound HealNCT04898816
Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures
A study testing closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive and closure of wound using braided silk suture in people with Wound Heal, run by Melaka Manipal Medical College at 1 site in Malaysia.
Trial summary
This study compares the effectiveness of two materials used for intraoral wound closure after removal of impacted mandibular third molar tooth. One Group received braided black silk suture and the other group received N-butyl 2-octyl cyanoacrylate tissue adhesives. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive and closure of wound using braided silk suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Mar 2020to 25 Apr 2021
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients requiring surgical removal of mesioangular, position A impacted mandibular third molar
- clean incisions approximately 2-3 cms in length which can be approximated
- Healthy (ASAI) or patients with mild systemic disease no functional limitations
- Patients not allergic to the drugs or anesthetic agents used in the surgical protocol
Who cannot join
- Patients taking any medications that influences wound healing
- Patients on non steroidal anti inflammatory drugs
- smokers
- uncooperative patients patients allergic to cyanoacrylate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures in the Closure of Intraoral Surgical Wounds- A Randomized Clinical Trial
This study compares the effectiveness of two materials used for intraoral wound closure after removal of impacted mandibular third molar tooth. One Group received braided black silk suture and the other group received N-butyl 2-octyl cyanoacrylate tissue adhesives.
Read the detailed description
Conventional method of wound closure after removal of impacted mandibular molar is by suturing the wound using braided black silk suture and allowing for primary healing. Suturing in the most posterior region of oral cavity is not easy, it requires more time and additional skills as well. Patient has to come for a second visit for removal of suture. Moreover tight sutures may lead to ischemia and necrosis.
Tissue adhesives adopts the idea of sutureless wound closure. They are even sloughed off from the surface of mucosa 7 days after the application.
This study compares the effectiveness of conventional sutures and tissue adhesives in closure of intraoral surgical wounds after removal of mandibular third molar.
- Conditions
- Wound Heal
- Being tested
- closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive, closure of wound using braided silk suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesiveProcedure or surgery
Application of cyanoacrylate tissue adhesives over the surgical wound
closure of wound using braided silk sutureProcedure or surgery
suturing the surgical wound using braided black silk
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Application of cyanoacrylate tissue adhesive over the surgical wound Receives: Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive |
| Group B | Active comparator | Suturing the surgical wound using braided black silk Receives: Procedure: closure of wound using braided silk suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
Measured: 1st postoperative day
postoperative pain
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
Measured: 2nd postoperative day
Postoperative pain
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
Measured: 3rd postoperative day
Postoperative pain
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
Measured: 4th postoperative day
postoperative pain
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
Measured: 5th postoperative day
wound healing
A 5 point early wound healing scale assessing wound healing after 7 postoperative days.
Measured: 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start30 Mar 2020
- Primary completion25 Apr 2021
- Study completion25 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melaka Manipal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Kalam Azad, Melaka Manipal Medical College
- Investigators
- abdul K azad, Principal investigator, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898816
- Sponsor's protocol ID
- MMMC/FOD/AR/B8/E C-2020 (08)
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures in the Closure of Intraoral Surgical Wounds- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04898816
- Acronym / sponsor ID
- MMMC/FOD/AR/B8/E C-2020 (08)
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Melaka Manipal Medical CollegeUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 24 May 2021 (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.
This study compares the effectiveness of two materials used for intraoral wound closure after removal of impacted mandibular third molar tooth. One Group received braided black silk suture and the other group received N-butyl 2-octyl cyanoacrylate tissue adhesives.
Detailed description
Conventional method of wound closure after removal of impacted mandibular molar is by suturing the wound using braided black silk suture and allowing for primary healing. Suturing in the most posterior region of oral cavity is not easy, it requires more time and additional skills as well. Patient has to come for a second visit for removal of suture. Moreover tight sutures may lead to ischemia and necrosis.
Tissue adhesives adopts the idea of sutureless wound closure. They are even sloughed off from the surface of mucosa 7 days after the application.
This study compares the effectiveness of conventional sutures and tissue adhesives in closure of intraoral surgical wounds after removal of mandibular third molar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesiveApplication of cyanoacrylate tissue adhesive over the surgical wound |
| Group B | Active comparator | Procedure: closure of wound using braided silk sutureSuturing the surgical wound using braided black silk |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients requiring surgical removal of mesioangular, position A impacted mandibular third molar
- clean incisions approximately 2-3 cms in length which can be approximated
- Healthy (ASAI) or patients with mild systemic disease no functional limitations
- Patients not allergic to the drugs or anesthetic agents used in the surgical protocol
Key exclusion criteria (4 listed)
- Patients taking any medications that influences wound healing
- Patients on non steroidal anti inflammatory drugs
- smokers
- uncooperative patients patients allergic to cyanoacrylate
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 |
|---|---|---|
| closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesiveApplication of cyanoacrylate tissue adhesives over the surgical wound | Procedure or surgery | Group A |
| closure of wound using braided silk suturesuturing the surgical wound using braided black silk | Procedure or surgery | Group B |
Primary outcome
Postoperative pain
Time frame: 1st postoperative day
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
postoperative pain
Time frame: 2nd postoperative day
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
Postoperative pain
Time frame: 3rd postoperative day
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
Postoperative pain
Time frame: 4th postoperative day
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
postoperative pain
Time frame: 5th postoperative day
A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
wound healing
Time frame: 7th postoperative day
A 5 point early wound healing scale assessing wound healing after 7 postoperative days.
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 6 Apr 2023.
- Individual participant dataSharing planned: Yes
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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.
abdul K azad principal investigator
Melaka Manipal Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive and closure of wound using braided silk suture in people with Wound Heal, run by Melaka Manipal Medical College at 1 site in Malaysia.
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 4 inclusion and 4 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 6 Apr 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 Malaysia. 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?
Postoperative pain (time frame: 1st postoperative day). The study lists 6 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 6 Apr 2023.