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Decreasing Intraoperative Skin Damage in Prone Position Surgeries (P3I)

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ClinicalTrials.gov Identifier: NCT04884737
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Barbara Bates-Jensen, PhD, RN, FAAN, University of California, Los Angeles

Brief Summary:

Preventing Pressure Injuries among patients undergoing spinal or orthopedic surgery in the prone position is challenging because of position required for surgical access and limited availability of pressure reduction surfaces for prone position operating tables. A new dressing technology (Mepilex Border Flex® (MBF) provides increased conformability of the dressing to the skin with the ability of the dressing to move in all directions (e.g., 360-degree flexibility) with even slight body movements. Limited data exists on use of silicone foam dressings with all direction flexibility during prone surgical procedures.

We plan to recruit participants scheduled for surgery in the prone position at UCLA Santa Monica Medical Center and propose to examine use of the MBF dressings on the chest, iliac crest, and face (chin, cheeks, forehead) of patients undergoing this type of surgery using a prospective, non-randomized pre/post intervention clinical trial design.

Three outcome measures will be compared between patients undergoing prone surgery with standard care (no dressings, pressure reduction positioning on the operating table) and those with standard care and use of MBF dressings placed on the chest, iliac crest and face. First, we will compare incidence of erythema and pressure injuries on face, chest and iliac crest determined by visual skin assessment between the two groups. Next, we will compare incidence of moisture associated skin damage (MASD) and friction abrasions on face, chest and iliac crest determined by visual skin assessment between the two groups. Last, we will compare SEM measures indicative of pressure injury damage on face, chest, iliac crest between the two groups.

We will also complete a 6-month retrospective medical record review of patients who underwent prone surgeries from February 1, 2018 through July 31, 2018 to determine a historical pressure injury facility incident rate. The year 2018 was chosen to avoid changes associated with the COVID-19 pandemic.


Condition or disease Intervention/treatment Phase
Pressure Injuries, Prone, Surgery Other: Mepilex Border Flex® (MBF) dressing Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

In months 1-3 Pre-Intervention participants will have 6 skin assessments at face (chin, cheeks, forehead), chest, and iliac crest: preoperative, Post Anesthesia Recovery Unit, transfer to floor, and post-operative days 1, 3 and 5.

In months 4-6 Intervention participants will have the same skin assessments at the same times and will have the dressings placed pre-operatively and removed following surgery.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Decreasing Intraoperative Skin Damage in Prone Position Surgeries
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
No Intervention: Pre-Intervention
Pre-Intervention Group participants will have 6 visits. During the pre-intervention baseline (3 months) participants will undergo visual skin assessment and SEM Scanner readings at face (chin, cheeks, forehead), chest, and iliac crest, conducted by the research staff: 1.) consent and preoperative, 2.) immediately following surgery in the Post Anesthesia Recovery (PAR) Unit, 3.) on transfer to the floor unit, 4.) post-operative day 1, 5.) post-operative day 3 and 6.) post-operative day 5 or discharge from hospital (whichever occurs first). Combined visit time will be 1 hour and 40 minutes.
Experimental: Intervention
Intervention Group participants will have 7 visits. During intervention (3 months) research staff will conduct the visual skin assessment and SEM Scanner readings at face (chin, cheeks, forehead), chest, and iliac crest, and place the MBF dressings to the face (chin, cheeks, forehead), chest and iliac crest: 1.consent and preoperative, 2. MBF dressing placement, 3.) immediately following surgery in the PAR unit with the MBF dressings removed , 4.) on transfer to the floor unit, 5.) post-operative day 1, 6.) post operative day 3 and 7.) post-operative day 5 or discharge from hospital (whichever occurs first). Combined visit time will be 1 hour and 55 minutes.
Other: Mepilex Border Flex® (MBF) dressing
A new dressing technology (Mepilex Border Flex® (MBF)) provides increased conformability of the dressing to the skin with the ability of the dressing to move in all directions (e.g., 360-degree flexibility) with even slight body movements. Limited data exists on use of silicone foam dressings with all direction flexibility during prone surgical procedures.




Primary Outcome Measures :
  1. Intraoperative acquired pressure injuries (IAPI) [ Time Frame: Within 5 days of surgery ]
    Pressure damage to skin and soft tissues

  2. Erythema, abrasions, and Moisture associated skin damage (MASD) [ Time Frame: Within 5 days of surgery ]
    redness and skin damage from moisture or friction

  3. SEM Scanner values [ Time Frame: Within 5 days ]
    Readings of edema of the anatomic sites



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A participant must 18 years or older and is scheduled for surgery in the prone position to be conducted at UCLA Santa Monica Medical Center.

Exclusion Criteria:

  • Patients who are not scheduled for surgery in the prone position. Patients with known allergy to the components of the Mepilex Border Flex (MBF) dressing which consists of silicone, polyurethane, polyacrylate, viscose, polyester and polyolefin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884737


Contacts
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Contact: Barbara M Bates-Jensen, PhD, RN 6264378543 bbatesjensen@sonnet.ucla.edu
Contact: Heather E McCreath, PhD 3102670848 hmccreath@mednet.ucla.edu

Locations
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United States, California
UCLA Santa Monica Medical Center Recruiting
Santa Monica, California, United States, 90404
Contact: Barbara M Bates-Jensen, PhD, RN    626-437-8543    bbatesjensen@sonnet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Barbara Bates-Jensen, PhD, RN, FAAN, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04884737    
Other Study ID Numbers: 21-000240
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Crush Injuries
Wounds and Injuries