CLINICAL TRIALS PROFILE FOR DURAPREP

All Clinical Trials for Duraprep

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00739583 ↗	Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions	Completed	Johns Hopkins University	Phase 4	2008-08-01	Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the mark.
NCT00829023 ↗	Efficacy of Surgical Preparation Solutions in Shoulder Surgery	Completed	CareFusion	N/A	2007-06-01	The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.
NCT00829023 ↗	Efficacy of Surgical Preparation Solutions in Shoulder Surgery	Completed	Northwestern University	N/A	2007-06-01	The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.
NCT01233050 ↗	Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery	Completed	3M	N/A	2010-12-01	Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.
NCT01233050 ↗	Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery	Completed	University of Pennsylvania	N/A	2010-12-01	Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.
NCT01290978 ↗	Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin	Completed	Cyberderm Inc.	Phase 4	2010-02-01	The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.

Clinical Trial Conditions for Duraprep

Condition Name

Condition Name for Duraprep
Intervention	Trials
Surgical Site Infection	2
Anesthesia	1
Knee Osteoarthritis	1
Anesthesia, Local	1

Condition MeSH

Condition MeSH for Duraprep
Intervention	Trials
Surgical Wound Infection	3
Tissue Adhesions	1
Osteoarthritis, Knee	1
Osteoarthritis	1

Clinical Trial Locations for Duraprep

Trials by Country

Trials by Country for Duraprep
Location	Trials
United States	23
Canada	2
Mexico	1

Trials by US State

Trials by US State for Duraprep
Location	Trials
Pennsylvania	3
Maryland	2
California	2
Ohio	2
Illinois	1

Clinical Trial Progress for Duraprep

Clinical Trial Phase

Clinical Trial Phase for Duraprep
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	1
N/A	3

Clinical Trial Status

Clinical Trial Status for Duraprep
Clinical Trial Phase	Trials
Completed	6
Enrolling by invitation	1
Recruiting	1

Clinical Trial Sponsors for Duraprep

Sponsor Name

Sponsor Name for Duraprep
Sponsor	Trials
3M	2
Johns Hopkins University	1
McMaster University	1

Sponsor Type

Sponsor Type for Duraprep
Sponsor	Trials
Other	12
Industry	5

Transforming Surgical Outcomes: Clinical Trials, Market Analysis, and Projections for DuraPrep

Introduction

DuraPrep, a preoperative skin preparation solution, has been a cornerstone in surgical practices for its antimicrobial properties and effectiveness in reducing surgical site infections (SSIs). This article delves into the current clinical trials, market analysis, and future projections for DuraPrep, highlighting its significance in the medical field.

Clinical Evidence and Effectiveness of DuraPrep

DuraPrep Surgical Solution, which contains iodine povacrylex and isopropyl alcohol, has been extensively studied for its efficacy in preoperative skin preparation. Clinical evidence shows that DuraPrep significantly reduces the incidence of SSIs. For instance, a study found that the implementation of DuraPrep resulted in a greater than 50% reduction in overall SSI, sternal infection, and surgical intervention post-infection[1].

Resistance to Saline Rinse and Antimicrobial Persistence

DuraPrep has demonstrated superior resistance to removal by saline-soaked gauze and maintains its antimicrobial effectiveness for up to 48 hours after application. This persistence is crucial in preventing the regrowth of normal skin flora and reducing the risk of infection[1].

Comparative Studies

The PREP-IT trials, which include the Aqueous-PREP and PREPARE trials, are ongoing multicenter pragmatic cluster randomized crossover trials comparing the effectiveness of different antiseptic skin solutions, including DuraPrep. These trials aim to evaluate the primary outcome of surgical site infection and secondary outcomes such as unplanned fracture-related reoperations within 12 months[4].

Market Analysis for Dura Substitutes and Related Markets

While DuraPrep itself is not a dura substitute, understanding the broader market context of surgical solutions and dura substitutes provides valuable insights.

Global Dura Substitutes Market

The global dura substitutes market, which is closely related to the surgical solutions market, was estimated at USD 232.27 million in 2024 and is projected to grow at a CAGR of 3.63% from 2025 to 2030. This growth is driven by advancements in neurosurgical techniques, the increasing prevalence of conditions requiring cranial or spinal surgeries, and a rising preference for minimally invasive procedures[2].

Regional Market Dynamics

North America dominates the dura substitutes market with a significant share, attributed to increasing neurological procedures, advancements in biomaterials, and rising awareness among healthcare providers. The Asia Pacific region is expected to grow at the fastest CAGR, driven by rising incidences of neurological disorders, improved healthcare infrastructure, and an aging population[2].

Market Projections for Surgical Solutions

Growth Drivers

The market for surgical solutions, including preoperative skin preparations like DuraPrep, is driven by several factors:

• Advancements in Surgical Techniques: The increasing adoption of minimally invasive surgical procedures and advancements in neurosurgical techniques are driving the demand for effective preoperative skin preparations.
• Rising Prevalence of Neurological Conditions: Conditions such as traumatic brain injuries, meningiomas, and chiari malformations are on the rise, increasing the need for surgical interventions and, by extension, preoperative skin preparations[2].

Market Barriers

Despite the growth drivers, the market faces some barriers:

• Economic Pressure: The need to contain healthcare costs can hamper market growth.
• Clinical Effectiveness: The purchasing decisions of customers are increasingly influenced by evidence of clinical effectiveness, which can pose a barrier to the adoption of new products unless robust clinical evidence is available[5].

Future Outlook for DuraPrep and Related Markets

Clinical Trials Impact

The ongoing PREP-IT trials and other clinical studies will provide critical evidence on the effectiveness of DuraPrep compared to other antiseptic solutions. These trials are expected to inform clinical guidelines and potentially lead to changes in clinical practice, further solidifying DuraPrep's position in the market[4].

Market Expansion

The global dura substitutes and surgical solutions markets are expected to experience moderate growth, driven by an aging population and an increase in patients requiring craniotomy interventions. The Asia Pacific region, in particular, is anticipated to see significant growth due to improving healthcare infrastructure and rising awareness of brain surgeries[2].

Key Takeaways

• Clinical Effectiveness: DuraPrep has shown significant reductions in SSIs and maintains antimicrobial effectiveness for up to 48 hours.
• Market Growth: The market for surgical solutions, including preoperative skin preparations, is expected to grow moderately, driven by advancements in surgical techniques and rising neurological conditions.
• Regional Dynamics: North America currently dominates the market, but the Asia Pacific region is expected to grow at the fastest CAGR.
• Clinical Trials: Ongoing trials will provide critical evidence to inform clinical guidelines and potentially change clinical practice.

FAQs

What is DuraPrep Surgical Solution?

DuraPrep Surgical Solution is a preoperative skin preparation containing iodine povacrylex and isopropyl alcohol, designed to reduce surgical site infections.

How effective is DuraPrep in reducing SSIs?

DuraPrep has been shown to reduce SSIs by more than 50% and significantly lower the rate of sternal infections and surgical interventions post-infection[1].

What are the key drivers of the dura substitutes market?

The key drivers include advancements in neurosurgical techniques, the increasing prevalence of conditions requiring cranial or spinal surgeries, and a rising preference for minimally invasive procedures[2].

Which region is expected to grow the fastest in the dura substitutes market?

The Asia Pacific region is expected to grow at the fastest CAGR due to rising incidences of neurological disorders, improved healthcare infrastructure, and an aging population[2].

What are the ongoing clinical trials evaluating DuraPrep?

The PREP-IT trials, including Aqueous-PREP and PREPARE, are ongoing multicenter pragmatic cluster randomized crossover trials comparing the effectiveness of different antiseptic skin solutions, including DuraPrep[4].

Sources

1. 3M™ DuraPrep™ Surgical Solution Clinical Evidence Summary.
2. Grand View Research - Dura Substitutes Market Size & Share | Industry Report 2030.
3. Global Clinical Trials Market Size, Top Share, Trends, Forecast by Straits Research.
4. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections - JAMA Network Open.
5. GlobalData - Dura Substitutes Market Size by Segments, Share, Regulatory.