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Use of Chitosan Powder in Loop Electrosurgical Excision Procedure

Primary Purpose

Vaginal Bleeding, Loop Electrosurgical Excision

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Chitosan
Sponsored by
Erzincan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaginal Bleeding

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: women were aged > 21 years old women were not pregnant women who were undergoing LEEP. Exclusion Criteria: Women with pelvic infection Women with abnormal vaginal bleeding Women with coagulopathy Women with chronic pain syndromes Women with psychiatric disorders Women with the previous hysterectomy with removal of the cervix, Women with a history of cervical cancer Women who could not complete follow-up calls

Sites / Locations

  • Kemal GüngördükRecruiting
  • Mugla Sıtkı Kocman University Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Chitosan

Arm Description

LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. An empty spray pump was used because we cannot find any identical powder for the placebo

LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. The application of 3 or 4 pumps of chitosan powder was carried out into the wound bed by spray pump which was prepared by a nurse.

Outcomes

Primary Outcome Measures

median early postoperative blood loss
early postoperative blood loss using the difference in hematocrit values after LEEP and 24 h after the procedure according to the following formula: estimated blood loss = estimated blood volume × (hematocrit 1 - hematocrit 2) / hematocrit 1, where the estimated blood volume in milliliters = body weight in kilograms × 85

Secondary Outcome Measures

Wound healing score
wound healing score was evaluated according to scale (min: 0, max:4)

Full Information

First Posted
December 13, 2022
Last Updated
August 20, 2023
Sponsor
Erzincan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05661708
Brief Title
Use of Chitosan Powder in Loop Electrosurgical Excision Procedure
Official Title
Use of Chitosan Powder in Loop Electrosurgical Excision Procedure to Reduce Postoperative Complications: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Early treatment of cervical intraepithelial neoplasia (CIN) II-III gives rise to a decrease in the incidence of invasive cervical cancer. Though there is no obvious consensus from randomized studies as to the optimal management of CIN II-III, loop electrosurgical excision procedure (LEEP) is the most extensively used method because of its technical ease, inexpensive, steep learning curve, and low rate of complications. In spite of these benefits, current literature suggests that some patients experience some complications such as postoperative vaginal bleeding, abnormal vaginal discharge, abdominal pain, and infection. These adversely affect the recovery period, increase patient anxiety, readmission to the hospital for further treatment and encumber patients' daily life. Postoperative vaginal bleeding (PVB) is one of the most common and unpleasant of these complications. Its incidence has been reported to vary between 2% to 78%. Many different types of treatments have been applied to avert or diminish PVC such as the use of vasopressin, tranexamic acid, Monsel's solution, and local hemostats (e.g., TachoSil or Tisseel), but these attempts have failed to show precise benefits over routine clinical approaches. Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic, non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin. Due to its molecular characteristics, chitosan has been used for improved hemostasis. Furthermore, chitosan has an antimicrobial and wound-healing effect. The current literature concerning the influence of using chitosan after the LEEP is limited to only one trial. The authors of that study reported that using chitosan after the LEEP can reduce vaginal bleeding and enhancing wound healing. However, that study has some limitations. Therefore, investigators designed this randomized trial to assess the effect of local chitosan implementation on postoperative vaginal bleeding and wound healing in LEEP

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Bleeding, Loop Electrosurgical Excision

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. An empty spray pump was used because we cannot find any identical powder for the placebo
Arm Title
Chitosan
Arm Type
Experimental
Arm Description
LEEP was performed in an outpatient setting by a single resident physician (KG). A full blood count was taken (hematocrit 1). The procedure was designed according to colposcopic findings such as the type of transformation zone and position of the lesion. After positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) was applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix. LEEP was performed as described in a previous trial. After the hemostasis that obtained using the ball electrode at a 40-W coagulation setting, the remaining cervical tissue was washed with 20 ccs of sterile saline to ensure no active bleeding from the cervical wound. The application of 3 or 4 pumps of chitosan powder was carried out into the wound bed by spray pump which was prepared by a nurse.
Intervention Type
Drug
Intervention Name(s)
Chitosan
Intervention Description
Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic, non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin. Due to its molecular characteristics, chitosan has been used for improved hemostasis. Furthermore, chitosan has an antimicrobial and wound-healing effect
Primary Outcome Measure Information:
Title
median early postoperative blood loss
Description
early postoperative blood loss using the difference in hematocrit values after LEEP and 24 h after the procedure according to the following formula: estimated blood loss = estimated blood volume × (hematocrit 1 - hematocrit 2) / hematocrit 1, where the estimated blood volume in milliliters = body weight in kilograms × 85
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Wound healing score
Description
wound healing score was evaluated according to scale (min: 0, max:4)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women were aged > 21 years old women were not pregnant women who were undergoing LEEP. Exclusion Criteria: Women with pelvic infection Women with abnormal vaginal bleeding Women with coagulopathy Women with chronic pain syndromes Women with psychiatric disorders Women with the previous hysterectomy with removal of the cervix, Women with a history of cervical cancer Women who could not complete follow-up calls
Facility Information:
Facility Name
Kemal Güngördük
City
Menteşe
State/Province
Muğla
ZIP/Postal Code
48000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kemal Güngördük
Phone
05057465266
Email
drkemalgungorduk@gmail.com
Facility Name
Mugla Sıtkı Kocman University Education and Research Hospital
City
Mugla
ZIP/Postal Code
48000
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mugla Sıtkı Kocman University Education and R Hospital
Phone
+905054921766
Email
drkemalgungorduk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Chitosan Powder in Loop Electrosurgical Excision Procedure

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