NCT02790177

Brief Summary

The objective of study is to determine the effect of hyaluronic acid on the formation of post-operative adhesions. It will be a randomized control trial comparing the product against normal saline.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2016

Status
unknown

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

First Submitted

Initial submission to the registry

May 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

May 23, 2016

Last Update Submit

May 29, 2016

Conditions

Post Operative Adhesions

Outcome Measures

Primary Outcomes (1)

  • POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL

    3 months

Study Arms (2)

HiB

EXPERIMENTAL

This group will receive the compound for the reduction of adhesions

Drug: Hyaluronic Acid

Normal saline

PLACEBO COMPARATOR

This group will just receive normal saline to ensure blinding.

Drug: NORMAL SALINE

Interventions

Hyaluronic AcidDRUG
HiB
NORMAL SALINEDRUG
Normal saline

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- All consenting patients between the ages of 12-80, who undergo exploratory laparotomy and stoma formation

You may not qualify if:

  • Previous history of abdominal surgery History of peritoneal dialysis Patients in whom permanent stoma is formed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hyaluronic AcidSaline Solution

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 3, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

June 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share