Role of Hyaluronic Acid in the Prevention of Post-operative Adhesions: a RCT (HiB)

Services Institute of Medical Sciences, Pakistan

Status and phase: Unknown; Phase 3

Conditions: Post Operative Adhesions

Treatments: Drug: Hyaluronic Acid; Drug: NORMAL SALINE

Study type: Interventional

Funder types: Other

Identifiers

NCT02790177

ServicesIMSP

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

HiB

Experimental group

Description:

This group will receive the compound for the reduction of adhesions

Treatment:

Drug: Hyaluronic Acid

Normal saline

Placebo Comparator group

Description:

This group will just receive normal saline to ensure blinding.

Treatment:

Drug: NORMAL SALINE