NCT01685593

Brief Summary

We conducted a controlled randomized trial examining the ability of the Mott abdominal Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

5.1 years

First QC Date

September 12, 2012

Last Update Submit

September 13, 2012

Conditions

Postoperative Pain

Keywords

abdominal binder

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    linear pain scale

    24 hours

Secondary Outcomes (1)

  • ambulations in 24 hours postoperatively

    24 hours

Other Outcomes (1)

  • amount morphine used in 24 hours postoperatively

    24 hours

Study Arms (2)

regular bandage

SHAM COMPARATOR

no abdominal binder

Other: no binder

abdominal binder

EXPERIMENTAL

binder

Device: abdominal binder

Interventions

abdominal binderDEVICE
abdominal binder
no binderOTHER
regular bandage

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • gynecologic abdominal laparotomy patients

You may not qualify if:

  • non gynecologic abdominal laparotomy patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78232, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 14, 2012

Study Start

January 1, 2001

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

US(1)