Mediolateral Episiotomy After DeliveryNCT00840788
Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy
A study testing octyl-2-cyanoacrylate adhesive glue and Subcuticular suture of perineal skin in people with Mediolateral Episiotomy After Delivery, run by Hospital Sao Joao at 1 site in Portugal.
Trial summary
Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mediolateral Episiotomy After Delivery
- What is being tested?
- octyl-2-cyanoacrylate adhesive glue and Subcuticular suture of perineal skin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- May 2005to Jan 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- vaginal delivery
- episiotomy performed
- no further perineal or vaginal lesions present
Who cannot join
- previously existing local infections or lesions
- body mass index > 35 (Kg/m2)
- severe pulmonary disease
- collagen disease
- known immunodeficiency
- diabetes mellitus
- immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Servico de Ginecologia e Obstetricia, Hospital de S, Joao
Porto, Porto District, 4200-319
About this study
Official title: Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.
Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.
- Conditions
- Mediolateral Episiotomy After Delivery
- Being tested
- octyl-2-cyanoacrylate adhesive glue, Subcuticular suture of perineal skin
- Keywords
- skin adhesive, tissue adhesive, mediolateral episiotomy, perineal repair, labor and delivery, repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octyl-2-cyanoacrylate adhesive glueProcedure or surgery
Also called Dermabond
use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy
Subcuticular suture of perineal skinProcedure or surgery
Also called Vicryl
Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair
| Study group | Role | What they receive |
|---|---|---|
| Skin adhesive | Experimental | perineal skin repair with octyl-2-cyanoacrylate skin adhesive Receives: Procedure: octyl-2-cyanoacrylate adhesive glue |
| subcuticular suture | Active comparator | continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910 Receives: Procedure: Subcuticular suture of perineal skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessed perineal pain
Measured: First 30 days after delivery
Secondary outcomes (7)
Total time spent with repair of episiotomy
Measured: within 1 hour after birth
Pain during procedure
Measured: within 1 hour after birth
Difficulties reported during procedure
Measured: within 1 hour after birth
Number of sutures and adhesive devices used
Measured: within 1 hour after birth
Wound complications
Measured: 42-68 hours after delivery
Need to seek health facilities
Measured: 30 days after delivery
Return of sexual activity
Measured: 30 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startMay 2005
- Primary completionMay 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediolateral Episiotomy After DeliveryStudies 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
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Joao
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Investigators
- Diogo Ayres-de-Campos, PhD, Principal investigator, Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840788
- Sponsor's protocol ID
- Episio- 01 - RCT
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2009
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00840788
- Acronym / sponsor ID
- Episio- 01 - RCT
- Conditions
- Mediolateral Episiotomy After Delivery
- Keywords
- skin adhesive, tissue adhesive, mediolateral episiotomy, perineal repair, labor and delivery, repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Sao JoaoUniversity, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- May 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 10 Feb 2009 (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.
Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin adhesive | Experimental | Procedure: octyl-2-cyanoacrylate adhesive glueperineal skin repair with octyl-2-cyanoacrylate skin adhesive |
| subcuticular suture | Active comparator | Procedure: Subcuticular suture of perineal skincontinuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- vaginal delivery
- episiotomy performed
- no further perineal or vaginal lesions present
Key exclusion criteria (7 listed)
- previously existing local infections or lesions
- body mass index > 35 (Kg/m2)
- severe pulmonary disease
- collagen disease
- known immunodeficiency
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 |
|---|---|---|
| octyl-2-cyanoacrylate adhesive glueAlso: Dermabonduse of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy | Procedure or surgery | Skin adhesive |
| Subcuticular suture of perineal skinAlso: VicrylUse of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair | Procedure or surgery | subcuticular suture |
Primary outcome
Self-assessed perineal pain
Time frame: First 30 days after delivery
7 secondary outcomes
Total time spent with repair of episiotomy
Time frame: within 1 hour after birth
Pain during procedure
Time frame: within 1 hour after birth
Difficulties reported during procedure
Time frame: within 1 hour after birth
Number of sutures and adhesive devices used
Time frame: within 1 hour after birth
Wound complications
Time frame: 42-68 hours after delivery
Need to seek health facilities
Time frame: 30 days after delivery
Return of sexual activity
Time frame: 30 days 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 10 Feb 2009.
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.
Diogo Ayres-de-Campos, PhD principal investigator
Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing octyl-2-cyanoacrylate adhesive glue and Subcuticular suture of perineal skin in people with Mediolateral Episiotomy After Delivery, run by Hospital Sao Joao at 1 site in Portugal.
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 7 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 10 Feb 2009. 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 Portugal. 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?
Self-assessed perineal pain (time frame: First 30 days after delivery). 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 10 Feb 2009.