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

Clinical trial on the use of surgical adhesive glue to repair first-degree perineal tears

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-52y5tq
Enrollment
Unknown
Registered
2020-09-17
Start date
2020-10-01
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: 42 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

Thaís Trevisan Teixeira
Lead Sponsor
Hospital Municipal Dr. Moysés Deutsch (M’Boi Mirim)
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: 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.

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.br+5511973799623

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 11, 2026