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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22789134
Publication citations
-
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.