Trial Outcomes & Findings for Abdominal Binder to Reduce Pain and Seroma Formation (NCT NCT01673568)

Results Overview

Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

24 hours after hernia repair

Results posted on

2014-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Abdominal Binder The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company. ETO garments: patients wearing abdominal binder for 7 days postoperatively	no Abdominal Binder no abdominal binder
Overall Study STARTED	28	28
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abdominal Binder to Reduce Pain and Seroma Formation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abdominal Binder n=28 Participants The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company. ETO garments: patients wearing abdominal binder for 7 days postoperatively	no Abdominal Binder n=28 Participants no abdominal binder was warn	Total n=56 Participants Total of all reporting groups
Age, Continuous	51 years n=93 Participants	51 years n=4 Participants	51 years n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours after hernia repair

Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.

Outcome measures

Outcome measures
Measure	Abdominal Binder n=28 Participants The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company. ETO garments: patients wearing abdominal binder for 7 days postoperatively	no Abdominal Binder n=28 Participants no abdominal binder
Visual Analog Scale of Pain Activity	50 units on a scale Interval 13.0 to 100.0	70 units on a scale Interval 11.0 to 97.0

SECONDARY outcome

Timeframe: postoperative day 7

Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.

Outcome measures

Outcome measures
Measure	Abdominal Binder n=28 Participants The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company. ETO garments: patients wearing abdominal binder for 7 days postoperatively	no Abdominal Binder n=28 Participants no abdominal binder
Seroma Formation	7 mL Interval 0.0 to 300.0	9 mL Interval 0.0 to 163.0

Adverse Events

Abdominal Binder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Abdominal Binder

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

Mette W. Christoffersen

Hvidovre Hospital University of Copenhagen

Phone: 38625826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place