Condition category
Surgery
Date applied
18/02/2011
Date assigned
31/03/2011
Last edited
13/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sami Shimi

ORCID ID

Contact details

Department of Surgery
University of Dundee
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8

Study information

Scientific title

A randomised, partially double-blind, controlled, parallel group study to evaluate the efficacy, safety and tolerability of pumactant 240mg in the prevention of the formation of peritoneal adhesions following abdominal surgery

Acronym

Study hypothesis

It is hypothesised that the application of pumactant powder into the abdominal cavity of human subjects following abdominal surgery may significantly reduce adhesion formation and potentially their associated morbidity. This trial was carried out to evaluate the efficacy of pumactant in reducing the formation of new peritoneal adhesions or the reformation of adhesions following abdominal surgery and its safety.

Ethics approval

Tayside Committee on Medical Research Ethics, approved in February 2000.
At the time COREC identified Aberdeen Ethics committee as the Main REC (MREC) for this study. This was communicated and became effective from August 2004.

Study design

Randomised partially double-blind controlled parallel group multi-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post operative intraperitoneal adhesions

Intervention

On completion of the first surgical procedure for each subject, the peritoneum was cleansed and irrigated with saline. A single dose of pumactant powder 240 mg (comprising of 3 puffer devices administering 80 mg per device) was administered (according to the randomisation schedule) to the peritoneal surface as an airborne dispersion immediately prior to closure. This was puffed onto the surface of the peritoneal cavity via carbon dioxide (CO2), using a puffer device, in as even strokes as possible so as to obtain a uniform covering.

For subjects randomised to receive CO2 alone (placebo), the identical puffer device was used but this was loaded with an empty vial (i.e. it administered only CO2 into the peritoneal cavity). After recovery from surgery, patients were readmitted 3-6 months later for reversal of colostomy / ileostomy. At that stage, adhesions were assessed and a further dose of pumactant (240 mg) or placebo was administered into the peritoneal cavity. After discharge from the second surgery, the patients involvement in the trial ceased.

Intervention type

Drug

Phase

Not Applicable

Drug names

Pumactant

Primary outcome measures

The evaluation of the efficacy of pumactant 240 mg in reducing the formation of peritoneal adhesions following abdominal surgery

Secondary outcome measures

Evaluate the safety and tolerability of pumactant 240 mg used in the peritoneal cavity following abdominal surgery

Overall trial start date

01/04/2001

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female subjects ( > 18 years old) were recruited into the study if it was thought that at the primary surgical procedure, they required the formation of a temporary stoma
2. Patients undergoing emergency treatment of obstructed /perforated carcinoma of the bowel or colonic diverticulitis by Hartmanns procedure
3. Patients undergoing elective low anterior bowel resection for the treatment of rectal carcinoma requiring formation of a temporary ileostomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140 (70 participants in each arm)

Participant exclusion criteria

1. Patients unable to comply with the study requirements, had cognitive impairments, had a history of drug and / or alcohol abuse
2. Patients receiving steroid medication
3. Patients had metastatic disease
4. Patients had American Society of Anesthesiologists (ASA) fitness grade of IV or above
5. Pregnant or lactating females

Recruitment start date

01/04/2001

Recruitment end date

01/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Surgery
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

Research and Innovation Service, University of Dundee (UK)

Sponsor details

University of Dundee
Nethergate
Dundee
DD1 4HN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Britannia Pharmaceuticals Limited, Surrey (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22789134

Publication citations

  1. Results

    Shimi SM, Loudon MA, Pumactant in the prevention of postoperative adhesions: a randomized trial., J. Surg. Res., 2012, 178, 2, 677-684, doi: 10.1016/j.jss.2012.06.060.

Additional files

Editorial Notes