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Study on the use of surgical glue in the repair of cuts in the vagina

Clinical trial on the use of glue surgical to repair episiotomies and perineal lacerations

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2q5wy8
Enrollment
Unknown
Registered
2018-01-25
Start date
2017-02-03
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

Episiotomy or spontaneous first or second degree perineal lacerations, during delivery

Interventions

The intervention consists in the use of adhesive glue GLUBRAN-2® using suture with Vicryl® quickly absorbed in perineal repair in normal birth, in 140 women, being 35 divided in 4 groups: Group 1 - fo
Procedure/surgery
H02.478.676.570
A01.719

Sponsors

Escola de Artes Ciências e Humanidades da Universidade de São Paulo
Lead Sponsor
Autarquia Municipal de Saúde de Itapecerica da Serra
Collaborator

Eligibility

Sex/Gender
Female
Age
13 Years to 40 Years

Inclusion criteria

Inclusion criteria: To be primiparous; have in vaginal birth with episiotomy and first and second degree perineal tears

Exclusion criteria

Exclusion criteria: Have vaginal birth with intact perineum; third or fourth degree perineal tears; give up to continue the study

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. For purposes statistical analysis, pain will be categorized as painless (0-2), mild pain (3), moderate (4-6), severe (7-9) and unbearable (10).The outcome will be assessed in the following moments after birth: until 2 hours, 12-24 hours, 36-48 hours, 10-20 days, 50-70 days, 6-8 moths after delivery.

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, 10-20 days, 50-70 days and 6-8 moths after delivery. ;Increase of the level of satisfaction of woman with the perineal repair will be evaluated by the Likert scale to verify the satisfaction of the woman, from 12 hours after delivery until 8 months later. This scale has answers classified in five points, corresponding to: Very dissatisfied, Unsatisfied, Indifferent, Satisfied 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, 10-20 days, 50-70 days, 6-8 moths after delivery.;Decrease of perineal repair time, recorded will be used 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 ContactAdriana Caroci

Escola de Artes Ciências e Humanidades da Universidade de São Paulo

acaroci@usp.br+55(11)997573876

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 9, 2026