ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Oct 16, 2024

Keywords

ClinConnect Summary

The ENVELOP clinical trial is studying different ways to care for wounds after surgery for pilonidal sinus disease, which is a condition that can cause painful cysts near the tailbone. The trial compares two methods: one group of patients will receive a special type of wound care called negative-pressure wound therapy, which uses suction to help heal the wound, while another group will receive standard open wound care. Researchers want to find out which method leads to better healing and recovery based on patient experiences.

To be eligible for this trial, participants must be at least 18 years old and scheduled for elective surgery to remove a pilonidal sinus without closing the wound immediately. Those who have certain medical conditions or who are having emergency surgery won't be able to participate. If you join the study, you can expect to receive either of the two types of wound care and will be asked to fill out questionnaires about your recovery. This trial aims to improve post-surgery care for patients with pilonidal sinus disease, helping to ensure quicker and more effective healing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • i) They are aged 18 years or older
• • ii) They are undergoing elective pilonidal sinus excision without primary closure
• Exclusion Criteria:
• • i) They are unable to adhere to protocol requirements e.g. questionnaire completion
• • ii) They are undergoing emergency drainage for a pilonidal abscess
• • iii) They are undergoing surgery for a pilonidal sinus disease in locations other than the natal cleft
• • iv) They have underlying osteomyelitis
• • v) They have underlying fistulating disease e.g. Crohn's