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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure. |
|
| Control Arm | Placebo Comparator | Open appendectomy and standardized wound closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open appendectomy using Alexis Wound Retractor followed by standardized wound closure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 post operative days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Waxman, MD | Santa Barbara Cottage Hospital Director of Surgical Education | Principal Investigator |
| Todd Pederson, MD | Santa Barbara Cottage Hospital/Naval Hospital | Principal Investigator |
| Benedict Taylor, MD | Santa Barbara Cottage Hospital Surgical Resident | Principal Investigator |
| Pamela Lee, MD | Santa Barbara Cottage Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 21 post operative days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Infection | Skin and subcutaneous tissue disorders | Systematic Assessment | Wound Infection |
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This study population included gastric, hepato-biliary-pancreatic, as well as colorectal cases, whereas our study was limited to open appendectomy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Isaacs (Research Quality Assurance & Integrity Analyst) on behalf of Dr. Kenneth Waxman (PI) | Santa Barbara Cottage Hospital | 805-324-9255 | lisaacs@sbch.org |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| Open appendectomy with standardized wound closure | Procedure | 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants with physical barrier to protect the wound | Count of Participants | Participants |
|
| 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. |
|
|
| 0 |
| 61 |
| 1 |
| 61 |
| 0 |
| 61 |
| EG001 | 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. | 0 | 48 | 7 | 48 | 0 | 48 |
|
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| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |