Effectiveness of TRIONIC compresses to stop abdominal oozing after deep inferior epigastric perforator breast reconstruction surgery
| ISRCTN | ISRCTN18170773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18170773 |
| EudraCT/CTIS number | 2022-A02571-42 |
| Secondary identifying numbers | DIEP-TRIOc-11.2022 |
- Submission date
- 17/04/2023
- Registration date
- 18/04/2023
- Last edited
- 24/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Breast reconstruction using the deep inferior epigastric perforator (DIEP) technique involves removing a piece of skin and fat from the abdominal region, as well as blood vessels (flap). This flap is placed in the thorax and the vessels of the flap are connected to the vessels of the thorax. The irrigated flap is then shaped to look like a natural breast. In the area where the flap has been harvested (donor site), electrocoagulation (conventional vessel closure technique) is used to limit haemorrhagic oozing (small flows of lymph and blood). Then drains (tubes) connected to bottles are placed in the abdominal area and the donor site is closed. The abdominal drains are used to drain off any haemorrhagic ooze that may accumulate after surgery. If these fluids are not drained, they can lead to complications such as seromas (accumulation of lymph) or haematomas (accumulation of blood), which delay healing. Drains are removed as soon as there is no or very little fluid to drain. TRIONIC compresses are indicated to reduce haemorrhagic oozing. The aim of this study is to demonstrate the effectiveness of TRIONIC in reducing haemorrhagic oozing at the flap donor site.
Who can participate?
Women aged over 18 years having DIEP flap reconstruction
What does the study involve?
Patients will be randomly assigned to either the TRIONIC group (TRIONIC is used on the donor site after electrocautery) or the control group (electrocautery alone). After surgery, the daily volume of abdominal fluid drained and the duration of the abdominal drain are noted. Abdominal complications are monitored for 3 weeks after surgery.
What are the possible benefits and risks of participating?
Participants may benefit from a decrease in drain duration and in the volume of fluid drained. No risks have been identified.
Where is the study run from?
A number of French hospitals. The lead centre is Hopital Européen Georges Pompidou, Paris (France)
When is the study starting and how long is it expected to run for?
January 2022 to February 2024
Who is funding the study?
Laboratoires Brothier (France)
Who is the main contact?
Laurent Lantieri, laurent.lantieri@aphp.fr
Contact information
Principal Investigator
Hôpital Européen Georges Pompidou, APHP
Chirurgie plastique reconstructrice et esthétique
20 rue Leblanc
Paris
75015
France
| Phone | +33 (0)1 56 09 53 20 |
|---|---|
| laurent.lantieri@aphp.fr |
Study information
| Study design | Multicentre prospective randomized 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 contact details to request a participant information sheet |
| Scientific title | Efficacy of TRIONIC after electrocautery vs electrocautery alone in controlling haemorrhagic oozing from the deep inferior epigastric perforator flap donor site - a multicenter randomized clinical investigation |
| Study acronym | TRIOD |
| Study objectives | It is hypothesized that TRIONIC could reduce haemorrhagic oozing postoperatively. |
| Ethics approval(s) | Approved 01/02/2023, CPP Sud Est 1 (CPP: Comité de protection des personnes = protection committee for people (involved in the study)) (CHU - Hôpital Bellevue DAMR - pavillon 31, 42055 Saint-Étienne Cedex 2, France; +33 (0)4 77 12 70 08; cpp.sudest1@chu-st-etienne.fr), ref: not applicable |
| Health condition(s) or problem(s) studied | Female adult patients having breast reconstruction with deep inferior epigastric perforator (DIEP) flap |
| Intervention | Patients are randomized (Interactive Web Response System [IWRS]) during surgery after electrocautery of the abdominal area. According to the randomization, patient will be treated with TRIONIC or not. TRIONIC will be applied and maintained in place until the bleeding stops. TRIONIC will be removed before closing the surgical site. Duration of follow-up: 21 days (+/- 3 days). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | TRIONIC (alginate) |
| Primary outcome measure | Number of days of abdominal drainage from placement of the abdominal drains until a volume of 20 ml/24 h is in each of the two drainage bottles |
| Secondary outcome measures | 1. Total volume of abdominal drainage fluid collected in the two drainage bottles from placement of the drains until a drainage volume ≤20 ml/24 h is achieved in each of the two bottles 2. Postoperative abdominal complications: 2.1. Percentage of patients with seroma and % of patients with haematoma during 21 days of follow-up 2.2. Percentage of patients with unhealed abdominal suture at 21 days after surgery 3. Tolerance: nature and frequency of TRIONIC-related incidents and adverse events (AEs) related to the investigation procedure |
| Overall study start date | 26/01/2022 |
| Completion date | 27/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 148 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Women aged 18 years or over 2. Undergoing unilateral or bilateral DIEP flap breast reconstruction 3. Having read and understood the patient information sheet and signed a written informed consent 4. Affiliated to the French social security system (“Sécurité sociale”) |
| Key exclusion criteria | 1. Patients with hemophilia, with Willebrand or Rendu-Osler disease or on long-term anticoagulant/antiplatelet treatment 2. Known to be allergic to the components of TRIONIC 3. End of hospitalization planned before the end of abdominal drainage 4. Might not return for the end-of-study visit 5. Under legal protection and/or unable to give written informed consent herself 6. Participating or going to participate or having taken part simultaneously in another trial which could have an impact on haemorrhagic oozing in the abdominal layer |
| Date of first enrolment | 27/04/2023 |
| Date of final enrolment | 08/02/2024 |
Locations
Countries of recruitment
- France
Study participating centres
20 rue Leblanc
Paris
75015
France
4 Rue de la Chine
Paris
75020
France
147 Bd Baille
Marseille
13005
France
1, avenue du Pr Jean Poulhès
Toulouse
31400
France
1 Place Alexis-Ricordeau
Nantes
44000
France
Sponsor information
Industry
41 rue de Neuilly
Nanterre
92000
France
| Phone | +33 (0)1 56 38 30 00 |
|---|---|
| Recherche.clinique@brothier.com | |
| Website | http://www.brothier.com |
"ROR" |
https://ror.org/007jkh405 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 09/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 24/06/2025 | 24/06/2025 | No | No |
Additional files
Editorial Notes
24/06/2025: The following changes were made to the study record:
1. Basic results uploaded.
2. Total final enrolment.
3. The recruitment end date was changed from 27/10/2024 to 08/02/2024.
4. The overall study end date was changed from 15/11/2024 to 27/02/2024.
02/06/2023: The following changes were made to the study record:
1. The recruitment start date was changed from 09/05/2023 to 27/04/2023.
2. The recruitment end date was changed from 09/11/2024 to 27/10/2024.
18/04/2023: Trial's existence confirmed by Brothier (France).
