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CompletedNCT00840788Updated Feb 10, 2009

Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

An interventional study of octyl-2-cyanoacrylate adhesive glue and Subcuticular suture of perineal skin in Mediolateral Episiotomy After Delivery, sponsored by Hospital Sao Joao. Completed at 1 site in Portugal. Open to female participants. Per ClinicalTrials.gov, last updated 2009-02-10.

Sponsored by Hospital Sao Joao · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
Female
01

Study 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 wound complications.

02

Conditions studied

  • Mediolateral Episiotomy After Delivery

Keywords

  • skin adhesive
  • tissue adhesive
  • mediolateral episiotomy
  • perineal repair
  • labor and delivery
  • repair
03

In context

Lead sponsor

Hospital Sao Joao is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • vaginal delivery
  • episiotomy performed
  • no further perineal or vaginal lesions present

Exclusion criteria

Exclusion Criteria:

  • previously existing local infections or lesions
  • body mass index > 35 (Kg/m2)
  • severe pulmonary disease
  • collagen disease
  • known immunodeficiency
  • diabetes mellitus
  • immunosuppressive treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Skin adhesive

    perineal skin repair with octyl-2-cyanoacrylate skin adhesive

    Procedure: octyl-2-cyanoacrylate adhesive glue

  • Active comparator
    subcuticular suture

    continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910

    Procedure: Subcuticular suture of perineal skin

Interventions

  • Procedureoctyl-2-cyanoacrylate adhesive glue

    use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy

    Also known as: Dermabond

  • ProcedureSubcuticular suture of perineal skin

    Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair

    Also known as: Vicryl

06

What researchers measure

Primary outcomes

  1. Self-assessed perineal pain

    Time frame: First 30 days after delivery

Secondary outcomes

  1. Total time spent with repair of episiotomy

    Time frame: within 1 hour after birth

  2. Pain during procedure

    Time frame: within 1 hour after birth

  3. Difficulties reported during procedure

    Time frame: within 1 hour after birth

  4. Number of sutures and adhesive devices used

    Time frame: within 1 hour after birth

  5. Wound complications

    Time frame: 42-68 hours after delivery

  6. Need to seek health facilities

    Time frame: 30 days after delivery

  7. Return of sexual activity

    Time frame: 30 days after delivery

07

Study locations

1 site
  • Servico de Ginecologia e Obstetricia, Hospital de S, Joao
    Porto, Porto District 4200-319, Portugal
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00840788
Lead sponsor
Hospital Sao Joao
Collaborators
Universidade do Porto
First posted
Feb 10, 2009
Start date
May 2005
Primary completion
May 2006
Completion
Jan 2007
Last update
Feb 10, 2009

Study contacts

Diogo Ayres-de-Campos, PhD
principal investigator · Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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