Appendicitis
Conditions
Keywords
Appendectomy, Surgery, Infection
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOpen appendectomy using Alexis Wound Retractor followed by standardized wound closure
The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
PROCEDUREOpen appendectomy with standardized wound closure
The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
Sponsors
Santa Barbara Cottage Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of appendicitis * Open appendectomy * Ability to attend follow-up visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Wound Infection, After Open Appendectomy | 21 post operative days | Wound infections will be documents in both the traditional retraction arm and the wound protections device arm. The severity of appendicitis between the two groups will be matched. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Arm The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.
Open appendectomy using Alexis Wound Retractor followed by standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure. | 61 |
| Control Arm Open appendectomy and standardized wound closure
Open appendectomy with standardized wound closure: The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure. | 48 |
| Total | 109 |
Baseline characteristics
| Characteristic | Experimental Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 18.9 | 33.1 years STANDARD_DEVIATION 16.1 | 34.4 years STANDARD_DEVIATION 17.7 |
| Number of Participants with physical barrier to protect the wound | 61 Participants | 48 Participants | 109 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 61 participants | 48 participants | 109 participants |
| Sex: Female, Male Female | 23 Participants | 16 Participants | 39 Participants |
| Sex: Female, Male Male | 38 Participants | 32 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 48 |
| other Total, other adverse events | 0 / 61 | 0 / 48 |
| serious Total, serious adverse events | 1 / 61 | 7 / 48 |
Outcome results
Primary
Post-operative Wound Infection, After Open Appendectomy
Wound infections will be documents in both the traditional retraction arm and the wound protections device arm. The severity of appendicitis between the two groups will be matched.
Time frame: 21 post operative days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Arm | Post-operative Wound Infection, After Open Appendectomy | 1 Participants |
| Control Arm | Post-operative Wound Infection, After Open Appendectomy | 7 Participants |