Green Draping for Hysteroscopy

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using green drapes in the operating room during hysteroscopy can speed up the procedure. Hysteroscopy allows doctors to examine the inside of the uterus. The study will also assess if green drapes affect infection rates, complications, or the time needed to prepare the room for the next surgery. Women scheduled for a hysteroscopy at certain Emory locations may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance surgical procedures.

Will I have to stop taking my current medications?

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

What prior data suggests that the Green Draping Procedure is safe for hysteroscopy?

Research has shown that using green drapes in operating rooms is generally safe. One study suggested that smaller surgical areas, such as those with green drapes, might offer a safe alternative to traditional methods. This switch could reduce risks compared to usual draping practices.

Hysteroscopy, a procedure where green drapes might be used, is considered safe with few complications. However, as with any procedure, risks such as bleeding can occur.

Overall, evidence suggests that green drapes are well-tolerated and do not significantly increase the risk of infections or complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Green Draping Procedure for hysteroscopy because it offers a potentially simpler and more efficient approach compared to the traditional full draping methods. Unlike the standard full draping, which can be time-consuming and resource-intensive, green draping aims to streamline the procedure, possibly leading to shorter preparation times and reduced material use. By innovating in procedural efficiency, this method could enhance patient comfort and improve overall clinical workflow during hysteroscopies.

What evidence suggests that the Green Draping Procedure is effective for reducing operating room time during hysteroscopy?

This trial will compare green draping procedures with conventional full draping procedures during hysteroscopy. Research has shown that green drapes in surgery are as safe as traditional methods, without increasing the risk of infections like urinary tract infections post-surgery. Studies have also found that this method makes operating rooms more environmentally friendly by reducing waste. While the main goal is to reduce surgery time, the green draping method effectively maintains patient safety. Therefore, it promises to improve surgical efficiency without compromising care. ^{1 3 4 6 7}

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

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 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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/green-draping-for-hysteroscopy-ac041

Green Draping for Hysteroscopy · Info for Participants The research suggests that using surgical drapes, like the Green Draping Procedure, can improve patient care by reducing the risk of complications during ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39514248/

Does Minimizing the Use of Drapes Increase Infection Rates? Conclusions: A green draping protocol is noninferior to standard draping with respect to rates of postoperative culture-positive UTIs.

3. mja.com.au mja.com.au/journal/2024/221/5/developing-green-operating-room-exploring-barriers-and-opportunities-reducing

Developing the green operating room: exploring barriers ... Developing the green operating room: exploring barriers and opportunities to reducing operating room waste

4. researchgate.net researchgate.net/publication/385677457_Green_Cystoscopy_Does_Minimizing_the_Use_of_Drapes_Increase_Infection_Rates

Does Minimizing the Use of Drapes Increase Infection Rates? The green draping protocol eliminated the use of top drapes, leg drapes, and gowns; blue towels were permitted per the surgeon's discretion. All minor ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34735388/

A Fluid-Management Drape for Hysteroscopy We assessed the effectiveness and usability of a novel total capture drape compared with a standard drape during hysteroscopy.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/41/NCT06379841/ICF_000.pdf

You Are Being Asked to Be in a Research Study The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in decreased operating room time. What ...

7. pubs.acs.org pubs.acs.org/doi/10.1021/es504719g

Environmental Impacts of Surgical Procedures: Life Cycle ... This paper presents a robust analysis of the life cycle impacts of a single surgical procedure, using four different surgical methods. Because the operating ...