Grade 1 Perineal TearsNCT00746707
Biologic Glue for First Degree Perineal Tears
A study testing 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate and 3. traditional suturing with vicryl rapid 2X0 in people with Grade 1 Perineal Tears, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Grade 1 Perineal Tears
- What is being tested?
- 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate and 3. traditional suturing with vicryl rapid 2X0
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Aug 2011
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears
Who cannot join
- excessive bleeding,
- chronic steroid treatment,
- immunosuppressive treatment,
- active infection,
- allergy to Dermabond or Histoacryl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears
The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair
Read the detailed description
This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.
- Conditions
- Grade 1 Perineal Tears
- Being tested
- 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate, 3. traditional suturing with vicryl rapid 2X0
- Keywords
- adhesive glue, perineal tear, suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Dermabond Topical Skin Adhesive 2-Octyl CyanoacrylateDevice
adhesive of perineal tears
3. traditional suturing with vicryl rapid 2X0Procedure or surgery
suturing of perineal tears grade one with vicryl rapid 2X0
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | use of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women Receives: Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate |
| 3 | Active comparator | use of traditional suturing for perineal tear grade 1 in 50 women Receives: Procedure: 3. traditional suturing with vicryl rapid 2X0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and cosmetic evaluation of perineal tear area.
Measured: At least six weeks after birth
Secondary outcomes (1)
Assessment of pain at least six weeks after delivery
Measured: At least six weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Grade 1 Perineal TearsStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezra Yosi, Hadassah Medical Organization
- Investigators
- yosef ezra, M.D., Study director, hadassha medical organization, jerusalem israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746707
- Sponsor's protocol ID
- feigenberg HMO-CTIL
- Status last verified
- Dec 2011
- First submitted
- 3 Sep 2008
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26.
PubMed 25089271
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears
- ClinicalTrials.gov ID
- NCT00746707
- Acronym / sponsor ID
- feigenberg HMO-CTIL
- Conditions
- Grade 1 Perineal Tears
- Keywords
- adhesive glue, perineal tear, suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Sep 2008 (estimated)
- 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 use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair
Detailed description
This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylateuse of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women |
| 3 | Active comparator | Procedure: 3. traditional suturing with vicryl rapid 2X0use of traditional suturing for perineal tear grade 1 in 50 women |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears
Key exclusion criteria (5 listed)
- excessive bleeding,
- chronic steroid treatment,
- immunosuppressive treatment,
- active infection,
- allergy to Dermabond or Histoacryl
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 |
|---|---|---|
| 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylateadhesive of perineal tears | Device | 1 |
| 3. traditional suturing with vicryl rapid 2X0suturing of perineal tears grade one with vicryl rapid 2X0 | Procedure or surgery | 3 |
Primary outcome
Functional and cosmetic evaluation of perineal tear area.
Time frame: At least six weeks after birth
1 secondary outcome
Assessment of pain at least six weeks after delivery
Time frame: At least six weeks after delivery
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 20 Dec 2011.
- Derived from this study: PubMed 25089271Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26.
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.
yosef ezra, M.D. study director
hadassha medical organization, jerusalem israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate and 3. traditional suturing with vicryl rapid 2X0 in people with Grade 1 Perineal Tears, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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 20 Dec 2011. 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 Israel. 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?
Functional and cosmetic evaluation of perineal tear area. (time frame: At least six weeks after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00746707, which also lists 1 linked publication.
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 20 Dec 2011.