Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy: A Factorial 2-by-2 Open-labeled Randomized Controlled Trial

Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy

Study Overview

• Status: Completed
• Conditions: Febrile Morbidity
• Intervention / Treatment: Procedure: Vagina douching; Procedure: Vagina painting

Detailed Description

Total abdominal hysterectomy (TAH) is the most common gynecologic operation worldwide. The two most common complications after TAH are febrile and infectious morbidities, incidence varying between 5 and 50 percent. After performing TAH, vaginal canal must be breached and closed to be blind-pouch stump. Routing vaginal douching at the night before and on the morning of the surgical date, and intra-operative painting are routinely practiced. However, no good quality of evidence base supports the effectiveness of vaginal douching and painting in preventing febrile and infectious morbidities after TAH.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who undergoing total abdominal hysterectomy
• Woman who agrees to participate in this study

Exclusion Criteria:

• Women with history of sea-food or iodine allergy
• Women who undergo emergency TAH
• Women who have intestinal resection in this operation
• Women who have active pelvic inflammatory disease before operation
• Women who have fever before operation
• Women who received antibiotic within 1 weeks before operation
• Women who be immunocompromised host

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control-douching group; No preoperative vagina douching
NO_INTERVENTION: Control-painting group; No intra-operative vagina painting
EXPERIMENTAL: Vaginal douching group; Preoperative vaginal douches with povidone-iodine solution	Procedure: Vagina douching; Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery
EXPERIMENTAL: Vaginal painting group; Intra-operative vaginal painting with povidone-iodine solution	Procedure: Vagina painting; Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Febrile morbidity	Defined as the presence of an oral temperature > 38 o C (100.4 o F) on two occasions at least 4 hours apart in the post-operative period excluding the first 24 hours	Day 1-7 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal cuff infection	Defined as redness, tenderness, infiltration or abscess at vaginal cuff	2 weeks after surgery
Other infectious morbidities	Defined by the presence of a urinary tract infection, abdominal wound infection, or pneumonitis; urinary tract infection defined as symptomatic infection with a mid-steam urine specimen showed bacterial growth > 105 bacteria/ml of urine; surgical wound infection defined as redness, tenderness, infiltration or abscess; pneumonitis defined as fever, physical and radiological findings of consolidation	2 weeks after surgery

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2018
• Primary Completion (ACTUAL): September 15, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (ACTUAL): May 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: RJVAG001

Drug and device information, study documents

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