Trial Outcomes & Findings for Decreasing Intraoperative Skin Damage in Prone Position Surgeries (NCT NCT04884737)
NCT ID: NCT04884737
Last Updated: 2023-05-31
Results Overview
Pressure damage to skin and soft tissues based on visual skin assessment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
Within 5 days of surgery
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
57
|
|
Overall Study
COMPLETED
|
39
|
48
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decreasing Intraoperative Skin Damage in Prone Position Surgeries
Baseline characteristics by cohort
| Measure |
Pre-Intervention
n=39 Participants
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
n=48 Participants
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.
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.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 Years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
61.0 Years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 days of surgeryPressure damage to skin and soft tissues based on visual skin assessment
Outcome measures
| Measure |
Pre-Intervention
n=39 Participants
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
n=48 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI)
|
13 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Within 5 days of surgeryredness and skin damage from moisture or friction
Outcome measures
| Measure |
Pre-Intervention
n=39 Participants
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
n=48 Participants
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.
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.
|
|---|---|---|
|
Number of Participant With Erythema, Abrasions, and Moisture Associated Skin Damage (MASD)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: preoperatively and first postoperative assessment (within 24 hours)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)
Outcome measures
| Measure |
Pre-Intervention
n=39 Participants
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
n=48 Participants
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.
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.
|
|---|---|---|
|
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
|
17 Participants
|
11 Participants
|
Adverse Events
Pre-Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Barbara Bates-Jensen, PhD, RN, FAAN
UCLA School of Nursing
Phone: 626-437-8543
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place