Trial Outcomes & Findings for Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings (NCT NCT02653183)
NCT ID: NCT02653183
Last Updated: 2019-07-01
Results Overview
Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
0-5 days
Results posted on
2019-07-01
Participant Flow
118 subjects were enrolled and 113 subjects were randomized, Out of the 113 randomized subjects. Screening failure, IP never applied, inclusion criteria inclusion criteria 4 not met.=5 Not included in the analysis The patient signed IC after data been entered into the eCRF. Excluded from the analysis=5
Participant milestones
| Measure |
Device Mepilex Border Post-Op
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
|
Overall Study
COMPLETED
|
49
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings
Baseline characteristics by cohort
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Type of surgery
Hip
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Type of surgery
Knee
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Skin type
Normal
|
45 participants
n=5 Participants
|
41 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Skin type
Dry
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Skin type
Oily
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-5 daysScale range from 0 (no dressing failure) to 7 ( complete dressing failure).
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Composite score 0
|
36 participants
|
32 participants
|
|
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Composite score1
|
10 participants
|
11 participants
|
|
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Composite score 2
|
0 participants
|
1 participants
|
|
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Composite score 3
|
4 participants
|
4 participants
|
|
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Composite score 4
|
3 participants
|
1 participants
|
|
Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing
Composite score 5
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 0-5 daysDressings adherence to the staples/sutures? Yes/No
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Dressings Adherence to the Staples/Sutures
No
|
53 participants
|
50 participants
|
|
Dressings Adherence to the Staples/Sutures
Yes
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-5 daysItching feeling under the dressing? Yes/No
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Itching Feeling Under the Dressing
No
|
53 participants
|
48 participants
|
|
Itching Feeling Under the Dressing
Yes
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 0-5 days4 point rating scale ( poor, good, very good,excellent)
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Patients Satisfaction With Wearing the Dressing
Poor
|
0 participants
|
1 participants
|
|
Patients Satisfaction With Wearing the Dressing
Good
|
13 participants
|
19 participants
|
|
Patients Satisfaction With Wearing the Dressing
Very good
|
22 participants
|
24 participants
|
|
Patients Satisfaction With Wearing the Dressing
Excellent
|
18 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 0-5 days4 point rating scale ( poor, good, very good,excellent)
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Nurses/Doctors Satisfaction With Applying the Dressing
Very Good
|
17 participants
|
12 participants
|
|
Nurses/Doctors Satisfaction With Applying the Dressing
Poor
|
2 participants
|
2 participants
|
|
Nurses/Doctors Satisfaction With Applying the Dressing
Good
|
13 participants
|
35 participants
|
|
Nurses/Doctors Satisfaction With Applying the Dressing
Excellent
|
21 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 0-5 days4 point rating scale ( poor, good, very good,excellent)
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Patients Mobility After Operation
Poor
|
0 participants
|
1 participants
|
|
Patients Mobility After Operation
Good
|
12 participants
|
19 participants
|
|
Patients Mobility After Operation
Very good
|
23 participants
|
24 participants
|
|
Patients Mobility After Operation
Excellent
|
18 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 0-5 daysLocal/systemic infection? Yes/No
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Local/Systemic Infection
No
|
53 participants
|
50 participants
|
|
Local/Systemic Infection
Yes
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 7Different adhesive on the dressings, can any difference be identified during dressing removal. Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable.
Outcome measures
| Measure |
Device Mepilex Border Post-Op
n=53 Participants
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 Participants
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Pain Level Before and During Dressing Removal
Pain before removal of dressing at last visit
|
7.8 units on a scale
Standard Deviation 13.8
|
4.9 units on a scale
Standard Deviation 6.3
|
|
Pain Level Before and During Dressing Removal
Pain during removal of dressing at last visit
|
6.9 units on a scale
Standard Deviation 11.7
|
10 units on a scale
Standard Deviation 12
|
Adverse Events
Device Mepilex Border Post-Op
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Device Aquacel Surgical
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Device Mepilex Border Post-Op
n=53 participants at risk
Post-operative all-in-one self-adherent soft silicone coated foam dressing.
Active Comparator: Aquacel Surgical: Post-operative all-in-one self-adherent soft silicone coated foam dressing
|
Device Aquacel Surgical
n=50 participants at risk
Aquacel Surgical is a sterile, one piece post-operative dressing from ConvaTec.
Experimental: Mepilex Border Post-Op: Aquacel Surgical is a sterile, one piece post-operative dressing
|
|---|---|---|
|
Surgical and medical procedures
Nausea
|
17.0%
9/53
|
16.0%
8/50
|
|
Surgical and medical procedures
Obstipation
|
9.4%
5/53
|
2.0%
1/50
|
|
Surgical and medical procedures
Allergic reaction
|
0.00%
0/53
|
2.0%
1/50
|
|
Surgical and medical procedures
Dizziness
|
1.9%
1/53
|
0.00%
0/50
|
|
Surgical and medical procedures
Elevated glucose levels
|
3.8%
2/53
|
4.0%
2/50
|
|
Surgical and medical procedures
Excema, medication related
|
1.9%
1/53
|
0.00%
0/50
|
|
Surgical and medical procedures
Fever
|
1.9%
1/53
|
2.0%
1/50
|
|
Surgical and medical procedures
Insomnia
|
0.00%
0/53
|
2.0%
1/50
|
|
Surgical and medical procedures
Itching
|
0.00%
0/53
|
2.0%
1/50
|
|
Surgical and medical procedures
Low hemoglobine level
|
1.9%
1/53
|
0.00%
0/50
|
|
Surgical and medical procedures
Skin allergy
|
1.9%
1/53
|
0.00%
0/50
|
|
Surgical and medical procedures
Confusion
|
1.9%
1/53
|
0.00%
0/50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER