Perineal TearNCT03983343
Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial
A study testing exofin® in people with Perineal Tear, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The incidence of a perineal tears during labor is 70 to 90%, while in 96% of the cases it's a minor perineal tear (grade 1). In about 3% to 4% the perineal tear is major and involve the external (grade 3) and the internal anal sphincter (grade 4). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perineal Tear
- What is being tested?
- exofin®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2019to 1 Aug 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45.
- Term birth (> 37.0 weeks).
- Perineal tears grade 1 or 2, or episiotomy.
Who cannot join
- Perineal tears grades 3 or 4.
- Operative vaginal deliveries.
- Significant background diseases that can affect pain or recovery time: Pregestational diabetes mellitus, any heart disease, severe pulmonary disease, collagen or connective tissue disease, rheumatic diseases, autoimmune diseases, known immunodeficiency and chronic steroid use.
- Signs of local infection prior to the beginning of repair of the tear.
- Known allergy to exofin®.
- Pregestational body mass index > 35 kg/m2.
- Women with excessive bleeding that does not allow the use of glue.
- Delivery of a dead fetus.
Trial locations and contacts
1 site in 1 country.
Raed Salim, MD contact
Israel1 site, 1 recruiting
- Recruiting
EMEK Medical center
Afula, 1834111
Nitzan Sela, MD, +972528244803, selanitzan@gmail.com
Nitzan Sela, MD
About this study
The incidence of a perineal tears during labor is 70 to 90%, while in 96% of the cases it's a minor perineal tear (grade 1). In about 3% to 4% the perineal tear is major and involve the external (grade 3) and the internal anal sphincter (grade 4). Episiotomy, which is considered an iatrogenic grade 2 tear, is performed in about 12% of vaginal deliveries.
Complications related to perineal tears include bleeding, the most common, that may lead to the development of vaginal or perineal hematoma. Additionally, local infection can develop and complicate the recovery from the injury. In rare cases, abscesses may occur and in rarer cases necrotizing fasciitis or recto-vaginal fistula may also evolve.
Read more
The "gold standard" method for repairing perineal tears is to use absorbable (preferably fast-absorbing) sutures. Grade 1 tears that do not bleed and do not disrupt the anatomical structure of the perineum usually do not require repair. Grade 2 tears are usually sewn in a continuous absorbent suture and less in the form of single stitches.
The use of adhesive glue to repair skin injuries began 20 years ago and the main adhesive used is dermabond® (Ethicon Inc. octyl-2-cyanoacrylate). The use of glue is faster and lead to less pain than the use of stitches or staples. It can be used for a variety of large or small, traumatic or iatrogenic wounds, with a cosmetic result, infection rate, and dehiscence rate similar to those achieved by stitches or staples.
In light of this, the investigators intend to conduct a randomized trial that will examine the advantages and disadvantages of the use of glue compared to the traditional sutures for closure of the skin in perineal tears grade 1 and 2 and episiotomies after vaginal delivery.
The investigators hypothesis is that the use of adhesive glue to close the skin in perineal tears grade 1 and 2 (including episiotomy), will be faster and associated with less pain compared to the traditional suturing method, without a significant difference in the rate of complications.
Read the detailed description
Trial design: Randomized controlled trial.
Objectives: To examine the effect of adhesive glue compared to fast-absorbable running sutures on pain sensation following repairing perineal skin in cases of tears grade 1 and 2.
Trial population: Women delivering vaginally at Emek Medical Center, and experience a spontaneous perineal tear, grade 1 or 2, or episiotomy.
Trial course:
Eligible patients will be asked to participate in this trial before perineal tear repair. Following providing an explanation about the trial, patients will be asked to provide written informed consent to participate in the trial.
The patients will be randomly assigned to one of the two groups in a 1:1 ratio:
- Suturing the perineal skin of the perineum using fast-absorbable running sutures (Vicryl Rapide 3-0)
- Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate). Other than skin closure, both groups will be treated similarly according to standard protocol used for perineal tear repair.
Sample size In order to detect a reduction of 20% in the VAS (visual analogue pain score) within 2 hours of the procedure between the groups [from 40% to 20% in the running sutures and glue groups, respectively) with a level of significance of 95% (α = 0.05 - two tailed) and a power of 80% (β = 0.2) a sample size of 182 women (91 per group) is needed.
Data collected during the study:
- Data collected during the repair of the tear: maternal age, ethnicity, pre-gestational body mass index, background medical conditions, medication use, smoking status, birth's number, number of vaginal/caesarean births in the past, perineal tears in the past, antenatal complications, gestational age at delivery, epidural use during labor, birth weight, gender, grade of tear, spontaneous or episiotomy, cross over (failure of completing the procedure with the assigned method), number of skin sutures/glue capsules that was used, length of the perineal incision, repair time, use of local analgesics during repair, pain sensation related to the procedure. Pain sensation will be evaluated within 2 hours using a 0 (no pain) to 100 Visual Analogue Scale (VAS). Additionally immediate breastfeeding will be assessed as well.
- Data collected 48 hours after the repair and prior to discharge: pain level during walking/standing/sitting/lying down, (pain will be evaluated using the same VAS), discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, local edema, local infection, separation of the edges of the wound, need for re-suturing, need to remove a stitch, woman's satisfaction and breastfeeding.
- Data collected 4-6 weeks after repair: women will be asked to return for check-up visit by a physician that was not involved in the repair and unaware of the allocation group. The outcomes that will be assessed at this visit will include: pain during walking/standing/sitting/lying, discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, time to return to sexual activity, dyspareunia, cosmetic result, skin dehiscence and granuloma, preference of women for the next delivery. A telephone questionnaire will be used to collect the same data among women who do not attend the clinic visit within 6 weeks.
- Conditions
- Perineal Tear
- Being tested
- exofin®
- Keywords
- Adhesive glue, Episiotomy, Pain sensation, Perineal tears, Running sutures, Skin closure, Visual Analogue Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exofin®Device
Perineal skin will be closed by adhesive glue - exofin® (Octyl-2-cyanoacrylate).
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Standard technique: Suturing the perineal skin with fast-absorbable running sutures (Vicryl Rapide 3-0). |
| intervention group | Active comparator | Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate) Receives: Device: exofin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured by asking the woman to describe the pain related to the procedure using a 0 (no pain) to 100 VAS (intolerable pain)
Measured: within 2 hours after completing the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Oct 2019
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Perineal TearStudies 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
- Model description
- Eligible patients will be asked to participate in this trial before perineal tear repair. The patients will be randomly assigned to one of the two groups in a 1:1 ratio: 1. Suturing the perineal skin of the perineum using fast-absorbable running sutures (Vicryl Rapide 3-0) 2. Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate). Other than skin closure, both groups will be treated similarly according to standard protocol used for perineal tear repair. In both groups, the walls of the vagina, the perineal muscles and the subcutaneous tissue will be repaired and approximated using the standard method, i.e. with running sutures using Vicryl Rapid Stitch 2-0.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Holy Family Hospital, Nazareth, Israel
- Responsible party
- Sponsor
- Investigators
- Raed Salim, MD, Study chair, Emek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983343
- Sponsor's protocol ID
- 0039-19-EMC
- Status last verified
- Aug 2023
- First submitted
- 10 Jun 2019
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Smith LA, Price N, Simonite V, Burns EE. Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013 Mar 7;13:59. doi: 10.1186/1471-2393-13-59.
PubMed 23497085Vale de Castro Monteiro M, Pereira GM, Aguiar RA, Azevedo RL, Correia-Junior MD, Reis ZS. Risk factors for severe obstetric perineal lacerations. Int Urogynecol J. 2016 Jan;27(1):61-7. doi: 10.1007/s00192-015-2795-5. Epub 2015 Jul 30.
PubMed 26224381Friedman AM, Ananth CV, Prendergast E, D'Alton ME, Wright JD. Variation in and factors associated with use of episiotomy. JAMA. 2015 Jan 13;313(2):197-9. doi: 10.1001/jama.2014.14774. No abstract available.
PubMed 25585333Kalis V, Laine K, de Leeuw JW, Ismail KM, Tincello DG. Classification of episiotomy: towards a standardisation of terminology. BJOG. 2012 Apr;119(5):522-6. doi: 10.1111/j.1471-0528.2011.03268.x. Epub 2012 Feb 3.
PubMed 22304364Leeman L, Rogers R, Borders N, Teaf D, Qualls C. The Effect of Perineal Lacerations on Pelvic Floor Function and Anatomy at 6 Months Postpartum in a Prospective Cohort of Nulliparous Women. Birth. 2016 Dec;43(4):293-302. doi: 10.1111/birt.12258. Epub 2016 Oct 31.
PubMed 27797099Kettle C, Dowswell T, Ismail KM. Continuous and interrupted suturing techniques for repair of episiotomy or second-degree tears. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD000947. doi: 10.1002/14651858.CD000947.pub3.
PubMed 23152204Feigenberg 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 25089271Singer AJ, Thode HC Jr. A review of the literature on octylcyanoacrylate tissue adhesive. Am J Surg. 2004 Feb;187(2):238-48. doi: 10.1016/j.amjsurg.2003.11.017.
PubMed 14769312Seijmonsbergen-Schermers AE, Sahami S, Lucas C, Jonge Ad. Nonsuturing or Skin Adhesives versus Suturing of the Perineal Skin After Childbirth: A Systematic Review. Birth. 2015 Jun;42(2):100-15. doi: 10.1111/birt.12166. Epub 2015 Apr 11.
PubMed 25864727Mota R, Costa F, Amaral A, Oliveira F, Santos CC, Ayres-De-Campos D. Skin adhesive versus subcuticular suture for perineal skin repair after episiotomy--a randomized controlled trial. Acta Obstet Gynecol Scand. 2009;88(6):660-6. doi: 10.1080/00016340902883133.
PubMed 19353332Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
PubMed 20596233Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 198: Prevention and Management of Obstetric Lacerations at Vaginal Delivery. Obstet Gynecol. 2018 Sep;132(3):e87-e102. doi: 10.1097/AOG.0000000000002841.
PubMed 30134424American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 165: Prevention and Management of Obstetric Lacerations at Vaginal Delivery. Obstet Gynecol. 2016 Jul;128(1):e1-e15. doi: 10.1097/AOG.0000000000001523.
PubMed 27333357
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03983343
- Acronym / sponsor ID
- 0039-19-EMC
- Conditions
- Perineal Tear
- Keywords
- Adhesive glue, Episiotomy, Pain sensation, Perineal tears, Running sutures, Skin closure, Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Holy Family Hospital, Nazareth, Israel
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Jun 2019 (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 incidence of a perineal tears during labor is 70 to 90%, while in 96% of the cases it's a minor perineal tear (grade 1). In about 3% to 4% the perineal tear is major and involve the external (grade 3) and the internal anal sphincter (grade 4). Episiotomy, which is considered an iatrogenic grade 2 tear, is performed in about 12% of vaginal deliveries.
Complications related to perineal tears include bleeding, the most common, that may lead to the development of vaginal or perineal hematoma. Additionally, local infection can develop and complicate the recovery from the injury. In rare cases, abscesses may occur and in rarer cases necrotizing fasciitis or recto-vaginal fistula may also evolve.
The "gold standard" method for repairing perineal tears is to use absorbable (preferably fast-absorbing) sutures. Grade 1 tears that do not bleed and do not disrupt the anatomical structure of the perineum usually do not require repair. Grade 2 tears are usually sewn in a continuous absorbent suture and less in the form of single stitches.
The use of adhesive glue to repair skin injuries began 20 years ago and the main adhesive used is dermabond® (Ethicon Inc. octyl-2-cyanoacrylate). The use of glue is faster and lead to less pain than the use of stitches or staples. It can be used for a variety of large or small, traumatic or iatrogenic wounds, with a cosmetic result, infection rate, and dehiscence rate similar to those achieved by stitches or staples.
In light of this, the investigators intend to conduct a randomized trial that will examine the advantages and disadvantages of the use of glue compared to the traditional sutures for closure of the skin in perineal tears grade 1 and 2 and episiotomies after vaginal delivery.
The investigators hypothesis is that the use of adhesive glue to close the skin in perineal tears grade 1 and 2 (including episiotomy), will be faster and associated with less pain compared to the traditional suturing method, without a significant difference in the rate of complications.
Detailed description
Trial design: Randomized controlled trial.
Objectives: To examine the effect of adhesive glue compared to fast-absorbable running sutures on pain sensation following repairing perineal skin in cases of tears grade 1 and 2.
Trial population: Women delivering vaginally at Emek Medical Center, and experience a spontaneous perineal tear, grade 1 or 2, or episiotomy.
Trial course:
Eligible patients will be asked to participate in this trial before perineal tear repair. Following providing an explanation about the trial, patients will be asked to provide written informed consent to participate in the trial.
The patients will be randomly assigned to one of the two groups in a 1:1 ratio:
- Suturing the perineal skin of the perineum using fast-absorbable running sutures (Vicryl Rapide 3-0)
- Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate). Other than skin closure, both groups will be treated similarly according to standard protocol used for perineal tear repair.
Sample size In order to detect a reduction of 20% in the VAS (visual analogue pain score) within 2 hours of the procedure between the groups [from 40% to 20% in the running sutures and glue groups, respectively) with a level of significance of 95% (α = 0.05 - two tailed) and a power of 80% (β = 0.2) a sample size of 182 women (91 per group) is needed.
Data collected during the study:
- Data collected during the repair of the tear: maternal age, ethnicity, pre-gestational body mass index, background medical conditions, medication use, smoking status, birth's number, number of vaginal/caesarean births in the past, perineal tears in the past, antenatal complications, gestational age at delivery, epidural use during labor, birth weight, gender, grade of tear, spontaneous or episiotomy, cross over (failure of completing the procedure with the assigned method), number of skin sutures/glue capsules that was used, length of the perineal incision, repair time, use of local analgesics during repair, pain sensation related to the procedure. Pain sensation will be evaluated within 2 hours using a 0 (no pain) to 100 Visual Analogue Scale (VAS). Additionally immediate breastfeeding will be assessed as well.
- Data collected 48 hours after the repair and prior to discharge: pain level during walking/standing/sitting/lying down, (pain will be evaluated using the same VAS), discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, local edema, local infection, separation of the edges of the wound, need for re-suturing, need to remove a stitch, woman's satisfaction and breastfeeding.
- Data collected 4-6 weeks after repair: women will be asked to return for check-up visit by a physician that was not involved in the repair and unaware of the allocation group. The outcomes that will be assessed at this visit will include: pain during walking/standing/sitting/lying, discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, time to return to sexual activity, dyspareunia, cosmetic result, skin dehiscence and granuloma, preference of women for the next delivery. A telephone questionnaire will be used to collect the same data among women who do not attend the clinic visit within 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be asked to participate in this trial before perineal tear repair. The patients will be randomly assigned to one of the two groups in a 1:1 ratio: 1. Suturing the perineal skin of the perineum using fast-absorbable running sutures (Vicryl Rapide 3-0) 2. Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate). Other than skin closure, both groups will be treated similarly according to standard protocol used for perineal tear repair. In both groups, the walls of the vagina, the perineal muscles and the subcutaneous tissue will be repaired and approximated using the standard method, i.e. with running sutures using Vicryl Rapid Stitch 2-0.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Standard technique: Suturing the perineal skin with fast-absorbable running sutures (Vicryl Rapide 3-0). |
| intervention group | Active comparator | Device: exofin®Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-45.
- Term birth (> 37.0 weeks).
- Perineal tears grade 1 or 2, or episiotomy.
Key exclusion criteria (8 listed)
- Perineal tears grades 3 or 4.
- Operative vaginal deliveries.
- Significant background diseases that can affect pain or recovery time: Pregestational diabetes mellitus, any heart disease, severe pulmonary disease, collagen or connective tissue disease, rheumatic diseases, autoimmune diseases, known immunodeficiency and chronic steroid use.
- Signs of local infection prior to the beginning of repair of the tear.
- Known allergy to exofin®.
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 |
|---|---|---|
| exofin®Perineal skin will be closed by adhesive glue - exofin® (Octyl-2-cyanoacrylate). | Device | intervention group |
Primary outcome
Pain intensity
Time frame: within 2 hours after completing the procedure
Pain intensity will be measured by asking the woman to describe the pain related to the procedure using a 0 (no pain) to 100 VAS (intolerable pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 23497085Smith LA, Price N, Simonite V, Burns EE. Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013 Mar 7;13:59. doi: 10.1186/1471-2393-13-59.
- Background: PubMed 26224381Vale de Castro Monteiro M, Pereira GM, Aguiar RA, Azevedo RL, Correia-Junior MD, Reis ZS. Risk factors for severe obstetric perineal lacerations. Int Urogynecol J. 2016 Jan;27(1):61-7. doi: 10.1007/s00192-015-2795-5. Epub 2015 Jul 30.
- Background: PubMed 25585333Friedman AM, Ananth CV, Prendergast E, D'Alton ME, Wright JD. Variation in and factors associated with use of episiotomy. JAMA. 2015 Jan 13;313(2):197-9. doi: 10.1001/jama.2014.14774. No abstract available.
- Background: PubMed 22304364Kalis V, Laine K, de Leeuw JW, Ismail KM, Tincello DG. Classification of episiotomy: towards a standardisation of terminology. BJOG. 2012 Apr;119(5):522-6. doi: 10.1111/j.1471-0528.2011.03268.x. Epub 2012 Feb 3.
- Background: PubMed 27797099Leeman L, Rogers R, Borders N, Teaf D, Qualls C. The Effect of Perineal Lacerations on Pelvic Floor Function and Anatomy at 6 Months Postpartum in a Prospective Cohort of Nulliparous Women. Birth. 2016 Dec;43(4):293-302. doi: 10.1111/birt.12258. Epub 2016 Oct 31.
- Background: PubMed 23152204Kettle C, Dowswell T, Ismail KM. Continuous and interrupted suturing techniques for repair of episiotomy or second-degree tears. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD000947. doi: 10.1002/14651858.CD000947.pub3.
- Background: 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.
- Background: PubMed 14769312Singer AJ, Thode HC Jr. A review of the literature on octylcyanoacrylate tissue adhesive. Am J Surg. 2004 Feb;187(2):238-48. doi: 10.1016/j.amjsurg.2003.11.017.
- Background: PubMed 25864727Seijmonsbergen-Schermers AE, Sahami S, Lucas C, Jonge Ad. Nonsuturing or Skin Adhesives versus Suturing of the Perineal Skin After Childbirth: A Systematic Review. Birth. 2015 Jun;42(2):100-15. doi: 10.1111/birt.12166. Epub 2015 Apr 11.
- Background: PubMed 19353332Mota R, Costa F, Amaral A, Oliveira F, Santos CC, Ayres-De-Campos D. Skin adhesive versus subcuticular suture for perineal skin repair after episiotomy--a randomized controlled trial. Acta Obstet Gynecol Scand. 2009;88(6):660-6. doi: 10.1080/00016340902883133.
- Background: PubMed 20596233Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
- Background: PubMed 30134424Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 198: Prevention and Management of Obstetric Lacerations at Vaginal Delivery. Obstet Gynecol. 2018 Sep;132(3):e87-e102. doi: 10.1097/AOG.0000000000002841.
- Individual participant dataSharing planned: Undecided
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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.
Raed Salim, MD contact
Raed Salim, MD study chair
Emek Medical Center, Afula, 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 exofin® in people with Perineal Tear, run by HaEmek Medical Center, Israel 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitzan Sela, MD (+972528244803, nitzanse@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: within 2 hours after completing the procedure). 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 NCT03983343, which also lists 13 linked publications.
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 22 Aug 2023.