Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears

Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears : A Comparative Study

Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.

The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure

Study Overview

• Status: Unknown
• Conditions: Episiotomy Wound
• Intervention / Treatment: Procedure: Episiotomy

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Normal vaginal delivery.
• At term (37 40 weeks ).
• Live baby.
• Vertex presentation

Exclusion Criteria:

• Third and fourth degree perineal tear.
• Instrumental vaginal delivery.
• Previous perineal surgery.
• Anaemia with hemoglobin level < 9 g/dl.
• Diabetes mellitus.
• Coagulation abnormalities.
• Postpartum hemorrhage.
• Delivery conducted outside Woman HealthHospital.
• Breech delivery.
• Body mass index >35 kg/m2.
• Local infectious lesions.
• Anal fissures or hemorrhoid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simple continuous; the sutures will be taken continuously by simple method	Procedure: Episiotomy; repair of perineal muscles and skin
Active Comparator: subcuticular; the sutures will be taken subcuticular	Procedure: Episiotomy; repair of perineal muscles and skin
Active Comparator: interrupted; the sutures will be taken interrupted method	Procedure: Episiotomy; repair of perineal muscles and skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the mean score of Perineal pain during vaginal suturing	assessment through visual analog scale score from 0 - 10 at every step of repair	10 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SCIE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No