- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07588412
Comparison of Standard Incision and Drainage Versus Percutaneous Suction Drainage in the Management of Acute Breast Abscess (I&D VS PSD)
A Comparative Study of Management of Acute /Pyogenic Breast Abscess Using Standard Incision and Drainage Versus Percutaneous Suction Drainage
연구 개요
상세 설명
Acute breast abscess is a common surgical condition requiring prompt intervention. Conventional incision and drainage (I&D) has been the standard treatment; however, it is associated with increased pain, prolonged healing, and frequent dressings. Minimally invasive techniques such as percutaneous suction drainage (PSD) have emerged as alternatives with potential advantages.
This prospective comparative interventional study was conducted at GSVM Medical College, Kanpur, from May 2025 to Feb 2026. Eighty patients diagnosed with acute pyogenic breast abscess were allocated into two groups: Group A (I&D) and Group B (PSD).
Outcomes assessed included postoperative pain (VAS score), duration of hospital stay, wound healing time, number of dressings, complications (residual abscess, fistula), and recurrence at 3 months. The study aims to compare the efficacy and safety of both treatment modalities.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Uttar Pradesh
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Kanpur, Uttar Pradesh, 인도, 208002
- Gsvm Medical College
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients diagnosed with acute pyogenic breast abscess
- Abscess size ≥ 3 cm on ultrasonography
- Willing to participate and provide written informed consent
Exclusion Criteria:
- Abscess size < 3 cm on ultrasonography
- Patients unwilling to provide informed consent
- Pre-existing skin disorders involving the breast
- Significant comorbid conditions (e.g., coagulopathy, diabetes mellitus, HIV infection, hepatitis B or C)
- Diagnosed cases of antibioma
- Tuberculous mastitis
- Breast malignancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Incision and Drainage
Standard surgical incision and drainage of breast abscess
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Standard surgical incision and drainage of breast abscess with evacuation of pus.
|
|
실험적: Percutaneous Suction Drain
Minimally invasive suction drain placement for breast abscess
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Minimally invasive placement of suction catheter for drainage of breast abscess.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative pain
기간: Day 1, 3, 7, 14, 30, 60, and 90 post procedure
|
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a patient-reported pain assessment scale ranging from 0 to 10, where: 0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain severity. Pain scores will be recorded on postoperative Day 1, Day 3, Day 7, Day 14, Day 30, Day 60, and Day 90 after the procedure. |
Day 1, 3, 7, 14, 30, 60, and 90 post procedure
|
|
Number of Dressings
기간: Within 30 days post-procedure
|
Total number of postoperative dressings required per patient in number
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Within 30 days post-procedure
|
|
Length of Hospitalization
기간: Up to 15 days post-procedure
|
Length of hospital stay measured in days from procedure to discharge
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Up to 15 days post-procedure
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|
Wound healing
기간: From procedure to complete wound healing (up to 30 days)
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Time to complete wound healing, defined as the number of days from the procedure to full epithelialization of the wound with absence of discharge, assessed by clinical examination.
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From procedure to complete wound healing (up to 30 days)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Residual Abscess
기간: Within 30 days post-procedure
|
Incidence of residual abscess, defined as the presence of a persistent or recurrent fluid collection at the original site confirmed by clinical examination and/or ultrasonography after the initial procedure.
|
Within 30 days post-procedure
|
|
FISTULA FORMATION
기간: Within 30 days post-procedure
|
Incidence of fistula formation, defined as the development of a persistent abnormal tract with discharge from the wound site following the procedure, confirmed by clinical examination.
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Within 30 days post-procedure
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Hassan SSU et al. (2024). Comparative study on recurrence rates: incision and drainage versus percutaneous aspiration in breast abscess. DOI: 10.54112/bcsir.v2024i1.783
- Prashanth C et al. (2024). Institutional comparative study: ultrasound-guided needle aspiration versus incision and drainage in 50 patients-success, healing, recurrence. DOI: 10.18203/2349-2902.isj20241308
- Khan MH et al. (2023). Prospective comparative study: percutaneous needle aspiration versus conventional incision and drainage in 120 breast abscess patients. DOI: 10.53350/pjmhs020231712516
- Singh SP et al. (2022). Extended cohort analysis: open incision and drainage versus ultrasound-guided minimally invasive procedures in breast abscess. DOI: 10.53730/ijhs.v6nS2.6001
- Singh SP et al. (2022). Prospective cohort study: incision and drainage versus ultrasound-guided minimally invasive drainage-healing, complications, recurrence. DOI: 10.53730/ijhs.v6nS1.5857
- Reddy KS et al. (2022). Clinical comparison of incision and drainage versus percutaneous suction drainage: healing, hospital stay, and scar quality. DOI: 10.33545/surgery.2022.v6.i3a.913
- Chorma A et al. (2022). Comparative three-arm investigation: conventional incision and drainage versus percutaneous suction drainage versus ultrasound-guided aspiration. DOI: 10.22159/ajpcr.2022.v15i11.45696
- Ali MN et al. (2020). Clinical study: ultrasound-guided needle aspiration versus surgical incision and drainage-outcomes and patient selection. DOI: 10.3329/taj.v33i1.49817
- Dayal P et al. (2019). Prospective randomized controlled trial: ultrasound-guided needle aspiration versus conventional incision and drainage in 100 patients with breast abscess. DOI: 10.32553/ijmbs.v3i4.201
- Kataria R et al. (2019). Randomized controlled trial: ultrasound-guided needle aspiration versus suction catheter drainage for breast abscess. DOI: 10.18203/2349-2902.isj20193682
- Oditya S et al. Comparative clinical study of conventional incision and drainage versus percutaneous suction catheter drainage in puerperal breast abscess. 2016. DOI: 10.18203/2349-2902.isj20162751
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- GSVMC-INT-2024-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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