Decreasing Intraoperative Skin Damage in Prone Position Surgeries

NCT04884737 | Completed Phase 4 Results FDA Device

• 1 other identifier: 21-000240
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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. The investigators will partents 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: (1) incidence of erythema and pressure injuries on face, chest and iliac crest determined by visual skin assessment between the two groups, (2) 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, and (3) SEM measures indicative of pressure injury damage on face, chest, iliac crest between the two groups. The study will also include 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.

Conditions

Pressure Injury

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI)

  Pressure damage to skin and soft tissues based on visual skin assessment

  Within 5 days of surgery

• Number of Participant With Erythema, Abrasions, and Moisture Associated Skin Damage (MASD)

  redness and skin damage from moisture or friction

  Within 5 days of surgery

• Number of Participants With a (Sub-epidermal Moisture) SEM Scanner Difference of Greater Than 0.5pF Measured at Preoperative Day of Surgery and at Least One Postoperative Assessment

  Difference of greater than 0.5pF between pre-operative and first post-operative readings of SEM (sub epidermal moisture or edema) at any anatomic site (face sites, chest, iliac crest)

  preoperatively and first postoperative assessment (within 24 hours)

Study Arms (2)

Pre-Intervention

NO 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.

Intervention

EXPERIMENTAL

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

Interventions

Mepilex Border Flex® (MBF) dressing OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Santa Monica Medical Center

Santa Monica, California, 90404, United States

Location

Related Publications (34)

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  BACKGROUND

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• Bates-Jensen BM, Crocker J, Nguyen V, Robertson L, Nourmand D, Chirila E, Laayouni M, Offendel O, Peng K, Romero SA, Fulgentes G, McCreath HE. Decreasing Intraoperative Skin Damage in Prone-Position Surgeries. Adv Skin Wound Care. 2024 Aug 1;37(8):413-421. doi: 10.1097/ASW.0000000000000186.

  PMID: 39037095 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Barbara Bates-Jensen, PhD, RN, FAAN
• Organization: UCLA School of Nursing

batesjen@sonnet.ucla.edu

626-437-8543

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: July 2, 2021
• Primary Completion: May 13, 2022
• Study Completion: March 10, 2023
• Last Updated: May 31, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)