Green Draping for Hysteroscopy

Recruiting at 2 trial locations

Overseen By Michael Heit, MD,PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Prisoners, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Baseline

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time. Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Green Draping Procedure safe for use in humans?

Hysteroscopy, which may involve procedures like Green Draping, is generally considered safe with low complication rates, though it can have risks like bleeding, infection, and uterine perforation. Proper management and preventative measures can enhance safety. ^{1 2 3 4 5}

What makes the Green Draping Procedure unique compared to other treatments for hysteroscopy?

The Green Draping Procedure is unique because it involves using a special type of surgical draping that may incorporate optical camouflage technology, potentially improving the visual environment during hysteroscopy. This approach is different from standard surgical draping as it might use materials that mimic natural vegetation reflectance, enhancing the surgical field's visibility and reducing glare. ^{6 7 8 9 10}

What data supports the effectiveness of the Green Draping Procedure treatment?

The research suggests that using surgical drapes, like the Green Draping Procedure, can improve patient care by reducing the risk of complications during surgery and enhancing patient comfort. This is supported by studies showing that draping techniques can decrease surgical time, maximize exposure, and reduce infection risk. ^{11 12 13 14 15}

Who Is on the Research Team?

Michael Heit, MD,PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals scheduled to undergo a hysteroscopy, which is a procedure used to examine the inside of the uterus. The study does not specify particular inclusion or exclusion criteria, so it's likely open to adults who meet standard requirements for this type of surgery.

Inclusion Criteria

All women undergoing a hysteroscopic procedure at Emory St Joseph's, Emory Dunwoody ASC, Emory University Hospital, Emory University Hospital ASC.

Exclusion Criteria

I have difficulty making decisions due to cognitive impairment.

Prisoners

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hysteroscopy with either full draping or green draping procedures

Baseline

1 visit (in-person)

Follow-up

Participants are monitored for post-operative complications and infection rates

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Green Draping Procedure

Trial Overview The study is testing two different preparation methods before a hysteroscopy: the traditional full draping and an alternative green draping technique. Researchers want to see if green draping can reduce time in the operating room and improve other outcomes like infection rates.

How Is the Trial Designed?

Group I: Green Draping Experimental Treatment 1 Intervention

This arm will follow the green draping procedures.

Group II: Full Draping Active Control 1 Intervention

This arm will follow the conventional full draping procedures.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Using a transparent head drape during surgery allows for continuous monitoring of the patient's head and upper limb positions, which can help prevent complications caused by malpositions.

This method is simple, cost-effective, and non-restrictive, ultimately improving the quality of patient care in the operating theatre.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[About a simple method to prevent accidents caused by changes in positioning in surgery: The transparent head drape]. Pauchot, J., Meresse, T., Di Tommaso, L., et al.[2022]

The new surgical draping technique reduces surgical time and improves exposure of the surgical site, which can lead to more efficient procedures.

This technique also aims to lower the risk of infection and enhance patient comfort during surgery, making it a beneficial approach for both surgeons and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Draping technique to isolate lashes and achieve maximum exposure. Slade, SG., Brint, SF.[2019]

The Steri-Drape eye drape is designed for ophthalmic surgeries like cataract extraction, providing effective fluid control during procedures.

The Steri-Drape procedural sheet serves as an all-in-one body sheet with absorbent properties, enhancing safety and cleanliness in surgical environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two sets of eye drapes. [2016]

In a study of 200 patients undergoing gynecologic laparoscopy, both maximum hygienic protocols and limited aseptic precautions resulted in low rates of perioperative infection, indicating that reduced hygiene measures may be safe for certain procedures.

No significant differences were found in clinical control parameters, such as perioperative temperature and white blood cell count, suggesting that minimizing standard hygienic measures could be feasible, but further research with a larger sample size is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of aseptic measures in gynecologic endoscopy: a comparative clinical trial. Aydeniz, B., Meyer, A., Geiss, HK., et al.[2019]

The lightweight surgical drape support enhances patient comfort during ophthalmic surgeries by preventing the drape from blocking the nasal and oral airways, which is crucial for procedures performed under local anesthesia.

This device is sterilizable and compact, ensuring it does not interfere with the surgeon or assistant's work during delicate microsurgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new surgical drape support. Carpel, EF.[2019]

Operative hysteroscopy is a minimally invasive and cost-effective procedure for treating benign uterine disorders, offering a safe alternative to major surgeries with low complication rates.

Awareness and management of potential complications, such as bleeding and uterine perforation, are essential for optimizing patient care and improving the safety of hysteroscopic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in operative hysteroscopy - is prevention possible? Aas-Eng, MK., Langebrekke, A., Hudelist, G.[2017]

Office Hysteroscopy (OH) is a safe and effective surgical technique for treating intracavitary uterine pathology, resolving over 90% of surgical needs without the need for an operating room or general anesthesia.

The implementation of OH contributes significantly to patient safety by reducing the risk of adverse events associated with traditional surgical methods, aligning with the World Health Organization's efforts to improve patient safety in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office Hysteroscopy. An operative gold standard technique and an important contribution to Patient Safety. Mairos, J., Di Martino, P.[2021]

Operative hysteroscopy is generally a safe procedure with excellent outcomes, but gynecologists must be aware of potential complications and manage them promptly to ensure patient safety and minimize legal risks.

Preoperative measures, such as using misoprostol or laminara, can reduce the risk of complications like uterine perforation, highlighting the importance of careful preoperative evaluation and fluid management during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in hysteroscopy: prevention, treatment and legal risk. Bradley, LD.[2022]

A survey of 212 gynaecologists in the UK revealed that while 64.7% always perform a vaginal examination before hysteroscopy, only a small percentage routinely sound (10.4%) or dilate (5.2%) the uterus prior to the procedure, indicating inconsistent safety practices.

The study identified a significant need for standardized guidelines in hysteroscopy to enhance safety measures and reduce the risk of uterine perforation, as many practitioners recognized dilatation as the most likely stage for such complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety aspects of hysteroscopy, specifically in relation to entry and specimen retrieval: a UK survey of practice. Walker, SH., Gokhale, L.[2022]

A study of 283 women undergoing outpatient hysteroscopy found that 88.7% would be willing to have the procedure again, indicating high acceptability for this method of diagnosing abnormal uterine bleeding.

Pain levels significantly influenced willingness to return for the procedure, with those experiencing higher pain scores (median VAS of 6.50) less likely to attend again, while the type of analgesia or anaesthetic did not affect their decision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient hysteroscopy: factors influencing post-procedure acceptability in patients attending a tertiary referral centre. McIlwaine, K., Readman, E., Cameron, M., et al.[2010]

The newly developed holographic corner cube retroreflector (HCCR) array functions as a color-selective wavelength filter, allowing for the tuning of diffracted light from 460 to 545 nm by adjusting the incident angle, which can enhance applications in photonic devices.

The HCCR array can also serve as effective optical sensors for temperature and humidity, providing a visible color change for quick diagnostics, showcasing its practical utility in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Color-selective holographic retroreflector array for sensing applications. Ahmed, R., Yetisen, AK., Yun, SH., et al.[2020]

The study presents a biomimetic film made of Ge/ZnS multilayers that effectively simulates the spectral characteristics of vegetation, achieving a high spectral similarity coefficient of 92.1% for hyperspectral camouflage.

This film not only provides effective camouflage against hyperspectral detection but also absorbs laser signals at 1.06 µm with a low reflectance of 17.8%, demonstrating its dual functionality and thermal stability up to 250 °C.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomimetic multilayer film simulating solar spectrum reflection characteristics of natural vegetations for optical camouflage. Deng, Z., Zhou, P., Hu, W., et al.[2023]

The new metal-based graphical hetero-structure (MGHS) camouflage shows high contrast colors and ultra-low infrared emissivity, making it effective for both visible and infrared light, with emissivity values as low as 0.04.

Different thicknesses of the color-controlling sub-layer (20, 40, and 60 nm) allow for the creation of various colors (yellow, navy, cyan) through constructive interference, demonstrating the potential for customizable camouflage patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metal-Based Graphical SiO₂/Ag/ZnS/Ag Hetero-Structure for Visible-Infrared Compatible Camouflage. Qi, D., Wang, X., Chen, F., et al.[2020]

A new remote sensing method using hyperspectroscopy can efficiently estimate various plant attributes, including biomass production and photosynthetic performance, with high accuracy and predictive capacity.

This method allows for the simultaneous determination of fifteen different plant characteristics, making it a valuable tool for studying plant physiology and photosystem dynamics, especially in large sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Quantification Method for Yield, Calorimetric Energy and Chlorophyll a Fluorescence Parameters in Nicotiana tabacum L. Using Vis-NIR-SWIR Hyperspectroscopy. Falcioni, R., Moriwaki, T., Antunes, WC., et al.[2023]

A new method using a Convolutional Neural Network has been developed to accurately extract vegetation spectral reflectance from ground-based hyperspectral imaging, achieving a high prediction accuracy of 98.1% in testing.

This method is effective even without knowing specific atmospheric conditions, making it a reliable tool for assessing plant health using non-invasive techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atmospheric correction of vegetation reflectance with simulation-trained deep learning for ground-based hyperspectral remote sensing. Qamar, F., Dobler, G.[2023]

Citations

1. France pubmed.ncbi.nlm.nih.gov

[About a simple method to prevent accidents caused by changes in positioning in surgery: The transparent head drape]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Draping technique to isolate lashes and achieve maximum exposure. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Two sets of eye drapes. [2016]

4. Ireland pubmed.ncbi.nlm.nih.gov

Reduction of aseptic measures in gynecologic endoscopy: a comparative clinical trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A new surgical drape support. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Complications in operative hysteroscopy - is prevention possible? [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

Office Hysteroscopy. An operative gold standard technique and an important contribution to Patient Safety. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Complications in hysteroscopy: prevention, treatment and legal risk. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Safety aspects of hysteroscopy, specifically in relation to entry and specimen retrieval: a UK survey of practice. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Outpatient hysteroscopy: factors influencing post-procedure acceptability in patients attending a tertiary referral centre. [2010]

11. England pubmed.ncbi.nlm.nih.gov

Color-selective holographic retroreflector array for sensing applications. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Biomimetic multilayer film simulating solar spectrum reflection characteristics of natural vegetations for optical camouflage. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Metal-Based Graphical SiO₂/Ag/ZnS/Ag Hetero-Structure for Visible-Infrared Compatible Camouflage. [2020]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Rapid Quantification Method for Yield, Calorimetric Energy and Chlorophyll a Fluorescence Parameters in Nicotiana tabacum L. Using Vis-NIR-SWIR Hyperspectroscopy. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Atmospheric correction of vegetation reflectance with simulation-trained deep learning for ground-based hyperspectral remote sensing. [2023]