Perineal Wound Complications After ELAPENCT04033484
Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE
A study testing Negative Pressure Wound Therapy in people with Perineal Wound Complications After ELAPE, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perineal Wound Complications After ELAPE
- What is being tested?
- Negative Pressure Wound Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal cancer within 4 cm of the anal verge
- T3 or T4, as determined by pre-operative MRI examination; patient did receive neoadjuvant chemoradiotherapy
- Absence of distant metastases
- Absence of intestinal obstruction
Who cannot join
- T1-T2, as determined by pre-operative MRI before neoadjuvant chemoradiotherapy
- Distant metastases
- Intestinal obstruction
- Pregnancy or lactating
- Contraindications to surgery
- A mental disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhen Jun. Wang
Beijing, 100020
Zhen Jun Wang, Prof., +86013601393711, hjg211@163.com
About this study
Official title: Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision
Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Negative pressure therapy has proven benefits in open wounds, and recently a negative pressure system has been developed for use on closed wounds at high risk of breakdown. A systematic review suggested a significant decrease in perineal wound complications when using incisional negative pressure wound therapy was demonstrated, with surgical site infection rates as low as 9% (vs 41% in control groups). The review suggested that incisional negative pressure wound therapy decreases perineal wound complications after abdominoperineal resection. Prospective study also suggested that after ELAPE the application of a negative pressure system to the perineal wound closed with biologic mesh may reduce perineal wound complications. The aim of the present study was to determine whether negative pressure therapy combined with biological mesh compared with biological mesh alone after ELAPE could improve wound healing.
- Conditions
- Perineal Wound Complications After ELAPE
- Being tested
- Negative Pressure Wound Therapy
- Keywords
- extralevator abdominoperineal excision, Perineal wound healing, negative pressure wound therapy, biological mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyProcedure or surgery
The perineal wound was reconstructed with biologic mesh after ELAPE. The subcutaneous adipose layer was closed with 2/0 vicryl sutures, and a suction drain was left in the deep layer. The subcuticular layer and skin were closed with 3/0 vicryl mattress sutures and the negative pressure system applied at 80 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Biological Mesh | Active comparator | Using biological mesh to recnostruct the pelvic floor following ELAPE Receives: Procedure: Negative Pressure Wound Therapy |
| Biological Mesh With Negative Pressure Wound Therapy | Experimental | Using biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE Receives: Procedure: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
perineal wound complications
perineal wound complications after pelvic floor reconstruction following ELAPE
Measured: 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Jul 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal Wound Complications After ELAPEStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033484
- Sponsor's protocol ID
- Bio-NEST 01
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Negative pressure therapy has proven benefits in open wounds, and recently a negative pressure system has been developed for use on closed wounds at high risk of breakdown. Prospective study also suggested that after ELAPE the application of a negative pressure system to the perineal wound closed with biologic mesh may reduce perineal wound complications. The aim of the present study was to determine whether negative pressure therapy combined with biological mesh compared with biological mesh alone after ELAPE could improve wound healing.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision
- ClinicalTrials.gov ID
- NCT04033484
- Acronym / sponsor ID
- Bio-NEST 01
- Conditions
- Perineal Wound Complications After ELAPE
- Keywords
- extralevator abdominoperineal excision, Perineal wound healing, negative pressure wound therapy, biological mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Negative pressure therapy has proven benefits in open wounds, and recently a negative pressure system has been developed for use on closed wounds at high risk of breakdown. A systematic review suggested a significant decrease in perineal wound complications when using incisional negative pressure wound therapy was demonstrated, with surgical site infection rates as low as 9% (vs 41% in control groups). The review suggested that incisional negative pressure wound therapy decreases perineal wound complications after abdominoperineal resection. Prospective study also suggested that after ELAPE the application of a negative pressure system to the perineal wound closed with biologic mesh may reduce perineal wound complications. The aim of the present study was to determine whether negative pressure therapy combined with biological mesh compared with biological mesh alone after ELAPE could improve wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological Mesh | Active comparator | Procedure: Negative Pressure Wound TherapyUsing biological mesh to recnostruct the pelvic floor following ELAPE |
| Biological Mesh With Negative Pressure Wound Therapy | Experimental | Procedure: Negative Pressure Wound TherapyUsing biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rectal cancer within 4 cm of the anal verge
- T3 or T4, as determined by pre-operative MRI examination; patient did receive neoadjuvant chemoradiotherapy
- Absence of distant metastases
- Absence of intestinal obstruction
Key exclusion criteria (6 listed)
- T1-T2, as determined by pre-operative MRI before neoadjuvant chemoradiotherapy
- Distant metastases
- Intestinal obstruction
- Pregnancy or lactating
- Contraindications to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyThe perineal wound was reconstructed with biologic mesh after ELAPE. The subcutaneous adipose layer was closed with 2/0 vicryl sutures, and a suction drain was left in the deep layer. The subcuticular layer and skin were closed with 3/0 vicryl mattress sutures and the negative pressure system applied at 80 mmHg | Procedure or surgery | Biological Mesh, Biological Mesh With Negative Pressure Wound Therapy |
Primary outcome
perineal wound complications
Time frame: 6 months after operation
perineal wound complications after pelvic floor reconstruction following ELAPE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: Yes. Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Negative pressure therapy has proven benefits in open wounds, and recently a negative pressure system has been developed for use on closed wounds at high risk of breakdown. Prospective study also suggested that after ELAPE the application of a negative pressure system to the perineal wound closed with biologic mesh may reduce perineal wound complications. The aim of the present study was to determine whether negative pressure therapy combined with biological mesh compared with biological mesh alone after ELAPE could improve wound healing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy in people with Perineal Wound Complications After ELAPE, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Gang Han, MD (+86013522867841, hjg211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perineal wound complications (time frame: 6 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.