An interventional study of Negative Pressure Wound Therapy in Perineal Wound Complications After ELAPE, sponsored by Beijing Chao Yang Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Treatment
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.
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This study's planned enrollment of 66 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
Using biological mesh to recnostruct the pelvic floor following ELAPE
Procedure: Negative Pressure Wound Therapy
Using biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE
Procedure: Negative Pressure Wound Therapy
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
perineal wound complications
perineal wound complications after pelvic floor reconstruction following ELAPE
Time frame: 6 months after operation
Plan to share: 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.
Supporting information: Study protocol
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Beijing Chao Yang Hospital