## Protocol Section
### Identification Module
**NCT ID:** NCT02286479

**Brief Title:** Comparison of Loop and Primary Incision&Drainage Techniques in the Emergency Department

**Official Title:** Comparison of Loop Drainage and Primary Incision and Drainage Techniques in Patients With Cutaneous Abscess in the Emergency Department

#### Organization Study ID Info
**ID:** KOU KAEK 2014/259
#### Organization
**Class:** OTHER
**Full Name:** Kocaeli University
### Status Module
#### Completion Date
**Date:** 2016-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-08-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-08-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-08

**Type:** ACTUAL

#### Start Date
**Date:** 2014-10

**Status Verified Date:** 2016-08

#### Study First Post Date
**Date:** 2014-11-07
**Type:** ESTIMATED
**Study First Submit Date:** 2014-11-05
**Study First Submit QC Date:** 2014-11-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kocaeli University

#### Responsible Party

**Investigator Affiliation:** Kocaeli University

**Investigator Full Name:** Ibrahim Ulas Ozturan

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Skin abscesses are among the most common soft tissue infections cause emergency room visits frequently. Management of abscess drainage and prevent further complications are important entities for emergency physicians. Historically primary incision and drainage (I\&D) technique has found very effective method of abscess drainage, however a novel technique loop drainage holds promising. The purpose of our study is comparison efficacy of I\&D and loop drainage techniques in patients with cutaneous abscess.

### Conditions Module

**Conditions:**

- Skin Abscess

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.

**Intervention Names:**

- Procedure: Incision and Drainage

**Label:** Incision and Drainage

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.

**Intervention Names:**

- Procedure: Loop drainage

**Label:** Loop drainage

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Incision and Drainage

**Description:** In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.

**Name:** Incision and Drainage

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Loop drainage

**Description:** In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.

**Name:** Loop drainage

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Measure:** Procedure Pain Intensity

**Time Frame:** intraoperative

#### Primary Outcomes

**Measure:** Abscess Resolution

**Time Frame:** 7 days

#### Secondary Outcomes

**Measure:** Procedure Time

**Time Frame:** intraoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients presenting to Kocaeli University Emergency Department with cutaneous abscess.
* Providing written informed consent.

Exclusion Criteria:

* Under 18 years of age.
* Immunosuppressive patients.
* Using medications have effects on wound healing.
* Abscess is not recognizable by bedside ultrasound.
* Lidocaine allergy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kocaeli

**Country:** Turkey

**Facility:** Kocaeli University Medical Faculty Emergency Medicine Department

**Zip:** 41730

### IPD Sharing Statement Module

**IPD Sharing:** YES

### References Module

#### References

**Citation:** Ozturan IU, Dogan NO, Karakayali O, Ozbek AE, Yilmaz S, Pekdemir M, Suner S. Comparison of loop and primary incision & drainage techniques in adult patients with cutaneous abscess: A preliminary, randomized clinical trial. Am J Emerg Med. 2017 Jun;35(6):830-834. doi: 10.1016/j.ajem.2017.01.036. Epub 2017 Jan 22.

**PMID:** 28162873

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000013492

- Term: Suppuration

- ID: D000007239

- Term: Infections

- ID: D000007249

- Term: Inflammation

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC01

- Name: Infections

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M1112

- Name: Surgical Wound

- Relevance: LOW

- As Found: Unknown

- ID: M37

- Name: Abscess

- Relevance: HIGH

- As Found: Abscess

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M16273

- Name: Suppuration

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000038

- Term: Abscess

- ID: D000004630

- Term: Emergencies

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
