Study to evaluate the efficacy, safety and tolerability of pumactant 240mg in the prevention of the formation of peritoneal adhesions following abdominal surgery
| ISRCTN | ISRCTN99599132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99599132 |
| Secondary identifying numbers | 8 |
- Submission date
- 18/02/2011
- Registration date
- 31/03/2011
- Last edited
- 13/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Sami Shimi
Scientific
Scientific
Department of Surgery
University of Dundee
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised partially double-blind controlled parallel group multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2001 |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 (70 participants in each arm) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2001 |
| Date of final enrolment | 01/07/2005 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Surgery
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
Research and Innovation Service, University of Dundee (UK)
University/education
University/education
University of Dundee
Nethergate
Dundee
DD1 4HN
Scotland
United Kingdom
"ROR" |
https://ror.org/03h2bxq36 |
|---|
Funders
Funder type
Industry
Britannia Pharmaceuticals Limited, Surrey (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2012 | Yes | No |
