Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

NCT ID: NCT03780530

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Episiotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

subcuticular suturing

Group Type ACTIVE_COMPARATOR

subcuticular suturing

Intervention Type PROCEDURE

Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).

surgical glue

Group Type ACTIVE_COMPARATOR

Surgical glue

Intervention Type PROCEDURE

Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).

adhesive steri-strip tape

Group Type ACTIVE_COMPARATOR

adhesive steri-strip tape

Intervention Type PROCEDURE

Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

subcuticular suturing

Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).

Intervention Type PROCEDURE

Surgical glue

Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).

Intervention Type PROCEDURE

adhesive steri-strip tape

Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged above 18 yrs.
* Primiparous.
* Undergoing spontaneous vaginal delivery of a single full-term fetus.
* Vertex presentation.
* Having mediolateral episiotomy.

Exclusion Criteria

* Body mass index ≥ 35 kg/m2
* Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.
* Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia.
* The use of epidural anesthesia.
* Previous perineal surgeries, local infection or lesions.
* Any medical condition that can cause excessive bleeding or impair wound healing; (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or Immunosuppression).
* Contraindication or Hypersensitivity to any of materials used in the study.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Radwa Rasheedy Ali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ain shams maternity U

Identifier Type: -

Identifier Source: org_study_id