Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE

NCT04033484 | Unknown

• 1 other identifier: Bio-NEST 01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

extralevator abdominoperineal excision; Perineal wound healing; negative pressure wound therapy; biological mesh

Outcome Measures

Primary Outcomes (1)

• perineal wound complications

  perineal wound complications after pelvic floor reconstruction following ELAPE

  6 months after operation

Study Arms (2)

Biological Mesh

ACTIVE COMPARATOR

Using biological mesh to recnostruct the pelvic floor following ELAPE

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

Procedure: Negative Pressure Wound Therapy

Interventions

Negative Pressure Wound Therapy PROCEDURE

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

Biological Mesh; Biological Mesh With Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• T1-T2, as determined by pre-operative MRI before neoadjuvant chemoradiotherapy
• Distant metastases
• Intestinal obstruction
• Pregnancy or lactating
• Contraindications to surgery
• A mental disorder

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Zhen Jun. Wang

Beijing, 100020, China

RECRUITING

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

Jia Gang Han, MD

CONTACT

+86013522867841; hjg211@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of General Surgery

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: July 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2019.07.1-2021.07.31
• Access Criteria: Inclusion criteria 1. Tumor within 4 cm of the anal verge 2. T3 or T4, as determined by pre-operative MRI examination; patient did receive neoadjuvant chemoradiotherapy 3. Absence of distant metastases 4. Absence of intestinal obstruction

Locations

CN (1)