Wound Infection Alexis Wound Retractor
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hospital, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/24/2018 |
Start Date: | March 2006 |
End Date: | June 2008 |
Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor
The purpose of this study is to determine whether the incidence of surgical site wound
infection will be reduced in open appendectomy patients through the use of the Alexis® wound
retractor.
infection will be reduced in open appendectomy patients through the use of the Alexis® wound
retractor.
Aim: This is a randomized comparison of open appendectomy using metal retractors and open
appendectomy using the Alexis® wound retractor in patients with simple and complicated
appendicitis. The study is designed in order to minimize bias by standardizing the two
procedures and blinding patients and nurses during the preoperative and postoperative period.
After obtaining informed consent, or informed assent of minors, subjects will be randomized
to either of two groups: one groups will undergo a standard open appendectomy using
traditional metal retractors. The second group will undergo an open appendectomy with the use
of the Alexis® wound retractor.
Pre-operative antibiotic Zosyn will be given prior to skin incision. Skin prep will be
betadine, duraprep or gel prep. After entering the peritoneal cavity, the Alexis® retractor
will be introduced and used to maintain retraction for the duration of surgery.
In simple appendicitis, the patient will receive one dose of antibiotics six hours after
surgery. The patient will not receive oral antibiotics at discharge. In complicated
appendicitis, the patient will be given Zosyn until afebrile for 24 hours and a normal white
blood cell count. The patient will be discharged on oral antibiotics.
Follow up will occur between the 14th and 21st post operative day. At the test of cure visit,
the wound will be checked for erythema, drainage, or opening. It will be assessed whether the
subject received any further medical attention or received medications since discharge.
appendectomy using the Alexis® wound retractor in patients with simple and complicated
appendicitis. The study is designed in order to minimize bias by standardizing the two
procedures and blinding patients and nurses during the preoperative and postoperative period.
After obtaining informed consent, or informed assent of minors, subjects will be randomized
to either of two groups: one groups will undergo a standard open appendectomy using
traditional metal retractors. The second group will undergo an open appendectomy with the use
of the Alexis® wound retractor.
Pre-operative antibiotic Zosyn will be given prior to skin incision. Skin prep will be
betadine, duraprep or gel prep. After entering the peritoneal cavity, the Alexis® retractor
will be introduced and used to maintain retraction for the duration of surgery.
In simple appendicitis, the patient will receive one dose of antibiotics six hours after
surgery. The patient will not receive oral antibiotics at discharge. In complicated
appendicitis, the patient will be given Zosyn until afebrile for 24 hours and a normal white
blood cell count. The patient will be discharged on oral antibiotics.
Follow up will occur between the 14th and 21st post operative day. At the test of cure visit,
the wound will be checked for erythema, drainage, or opening. It will be assessed whether the
subject received any further medical attention or received medications since discharge.
Inclusion Criteria:
- Clinical diagnosis of appendicitis
- Open appendectomy
- Ability to attend follow-up visit
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