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Evaluation of the effectiveness of Adhesive Tissue in the skin and mucosa of Perineal Tears

Adhesive Tissue to Repair First-Degree Perineal Tears: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2h84gt
Enrollment
Unknown
Registered
2017-08-31
Start date
2017-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First degree perineal laceration during delivery

Interventions

Experimental group: 10 women with first-degree perineal tears due to vaginal delivery will receive perineal repair by means of the ethyl-2-cyanoacrylate adhesive. The repair by means of the experiment
Procedure/surgery

Sponsors

Escola de Enfermagem da Universidade de São Paulo
Lead Sponsor
Pronto Socorro e Maternidade Zoraide Eva das Dores
Collaborator

Eligibility

Sex/Gender
Female
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: to have up to 6 centimetres of cervical dilation at the time the woman is invited to participate in the research; Do not use steroid substances; Do not present leucorrhoea or any signs of infection at the repair site; No diagnosis of diabetes mellitus; without history of allergy to surgical glue or formaldehyde; No difficulty in understanding the Portuguese language or in communication; Accept being submitted to perineal repair methods with skin adhesive or suture thread.

Exclusion criteria

Exclusion criteria: Do not have vaginal delivery; Not having first degree laceration with indication of suture; Have episiotomy or laceration of second, third or fourth degree; Have physometry; have vulvar varicose veins; Have complications from the childbirth or postpartum requiring hospital transfer of the woman to a hospital of high complexity.

Design outcomes

Primary

MeasureTime frame
Decrease of the intensity of perineal pain, verified through the Visual Numerical Scale (from 0 to 10 where 0 represents absence of pain and 10 the worst possible pain), considering the decrease of 2 or more points in the mean of the experimental group, related to the control group. The outcome will be assessed in the following moments after birth: until 2 hours, 12-24 hours, 36-48 hours and 10-20 days.

Secondary

MeasureTime frame
Increase of the perineal healing process, evaluated by the REEDA scale (redness, edema, ecchymosis, discharge and approximation, with an assigned score from 0 to 15), considering the decrease of 1 or more points in the mean of the experimental group, related to the control group. The outcome will be assessed in the following moments after birth: 12-24 hours, 36-48 hours and 10-20 days. Increase of the satisfaction of the woman with the perineal repair, analyzed through a scale likert (answers categorized in 4 points, corresponding to very unsatisfied, satisfied, unsatisfied and very satisfied), considering the increase of 2 or more points in the mean of the experimental group, related to the control group. The outcome will be assessed in the following moments after birth: until 2 hours, 12-24 hours, 36-48 hours and 10-20 days. Decrease of perineal repair time, recorded through a digital timer from the time the repair begins (included the local anestethic procedure) to finishs, considering the decrease of 3 or more minutes in the mean of the experimental group, related to the control group.

Countries

Brazil

Contacts

Public ContactThaís Teixeira

Escola de Enfermagem da Universidade de São Paulo

thais.trevisan.teixeira@usp.br55(11)3061-7607

Outcome results

None listed

Source: REBEC (via WHO ICTRP)