Clinical trials: Perineal Trauma
Perineal Tear and Episiotomy
The Effect of Mucogyne® Gel on Wound Healing
The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the…
- Trial name
- ARTHEMIS (NCT05888194)
- Testing
- Mucogyne® gel
- Where
- 3 sites in France
- Volunteers
- 118 people
- Sponsor
- Biocodex
Complication of Surgical Procedure
TCOT Effectiveness in Preventing Wound Infections in Perineal Resections
In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate.
- Trial name
- NCT02374294
- Testing
- Epiflo
- Sponsor
- Neogenix, LLC dba Ogenix
Pelvic Floor, Perineal Rupture
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of…
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Trial name
- NCT03883867
- Where
- 3 sites in United States, Czechia
- Volunteers
- 20 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Episiotomy, Perineal Wound Healing
Optimizing Early Episiotomy Wound Healing
This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early episiotomy wound healing.
- Trial name
- NCT07814781
- Testing
- Beta-Sitosterol Ointment, Hydrophilic Methacrylate Gel
- Where
- Qatar
- Volunteers
- 107 people
- Sponsor
- Hamad Medical Corporation
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
Perineal Laceration Repair
Comparison of Absorbable Sutures in Perineal Laceration Repair
The purpose of this study is to determine the difference in pain scales between absorbable suture types for second-degree perineal laceration repair.
- Trial name
- NCT00223119
- Testing
- Absorbable Sutures
- Where
- United States
- Sponsor
- Medtronic - MITG
Pregnancy, Childbirth
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a…
- Trial name
- PeriFlex (NCT06542744)
- Testing
- Training with the Emagina device at home until birth, No intervention
- Where
- 15 sites in France
- Volunteers
- 88 people
- Sponsor
- Mumming
Perineal Trauma
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth.
- Trial name
- ASISU-PMCF (NCT07844005)
- Testing
- Perineal protection device
- Where
- Denmark
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- oasicare ApS